Food and Drug Administration Modernization Act of 1997
PL 105-115 (S.830), enacted 11/21/1997

I l l STAT. 2296 
PUBLIC LAW 105-115—NOV. 21, 1997 
Public Law 105-115 
105th Congress 
An Act 
N 
21 1QQ7 
"^^ amend the Federal Food, Drug, and Cosmetic Act and the PubUc Health Service 
:— 
Act to improve the regulation of food, drugs, devices, and biological products, 
[8. 830] 
and for other purposes. 
Be it enacted by the Senate and House of Representatives 
of 
Food and Drug 
the United States of America in Congress assembled. 
Administration 
Modernization 
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS. 
2l\jSC?0^i note 
^^^ SHORT TiTLE.—This Act may be cited as the "Food and 
Drug Administration Modernization Act of 1997". 
(b) REFERENCES.—Except as otherwise specified, whenever in 
this Act an amendment or repeal is expressed in terms of an 
amendment to or a repeal of a section or other provision, the 
reference shall be considered to be made to that section or other 
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.). 
(c) TABLE OF CONTENTS.—The table of contents for this Act 
is as follows: 
Sec. 1. Short title; references; table of contents. 
Sec. 2. Definitions. 
TITLE I—IMPROVING REGULATION OF DRUGS 
Subtitle A—^Fees Relating to Drugs 
Sec. 101. Findings. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use drug fees. 
Sec. 104. Annual reports. 
Sec. 105. Savings. 
Sec. 106. Effective date. 
Sec. 107. Termination of effectiveness. 
Subtitle B—Other Improvements 
Sec. 111. Pediatric studies of drugs. 
Sec. 112. Expediting study and approval of fast track drugs. 
Sec. 113. Information program on clinical trials for serious or life-threatening dis-
eases. 
Sec. 114. Health care economic information. 
Sec. 115. Clinical investigations. 
Sec. 116. Manufacturing changes for drugs. 
Sec. 117. Streamlining clinical research on drugs. 
Sec. 118. Data requirements for drugs and biologies. 
Sec. 119. Content and review of applications. 
Sec. 120. Scientific advisory panels. 
Sec. 121. Positron emission tomography. 
Sec. 122. Requirements for radiopharmaceuticals. 
Sec. 123. Modernization of regulation. 
Sec. 124. Pilot and small scale manufacture. 
Sec. 125. Insulin and antibiotics. 
Sec. 126. Elimination of certain labeling requirements. 
Sec. 127. Application of Federal law to practice of pharmacy compounding. 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2297 
Sec. 128. Reauthorization of clinical pharmacology program. 
Sec. 129. Regulations for sunscreen products. 
Sec. 130. Reports of postmarketing approval studies. 
Sec. 131. Notification of discontinuance of a life saving product. 
TITLE II—IMPROVING REGULATION OF DEVICES 
Sec. 201. Investigational device exemptions. 
Sec. 202. Special review for certain devices. 
Sec. 203. Expanding humanitarian use of devices. 
Sec. 204. Device standards. 
Sec. 205. Scope of review; collaborative determinations of device data requirements. 
Sec. 206. Premarket notification. 
Sec. 207. Evaluation of automatic class III designation. 
Sec. 208. Classification panels. 
Sec. 209. Certainty of review timeframes; collaborative review process. 
Sec. 210. Accreditation of persons for review of premarket notification reports. 
Sec. 211. Device tracking. 
Sec. 212. Postmarket surveillance. 
Sec. 213. Reports. 
Sec. 214. Practice of medicine. 
Sec. 215. Noninvasive blood glucose meter. 
Sec. 216. Use of data relating to premarket approval; product development protocol. 
Sec. 217. Clarification of the number of required clinical investigations for ap-
proval. 
TITLE III—IMPROVING REGULATION OF FOOD 
Sec. 301. Flexibility for regulations regarding claims. 
Sec. 302. Petitions for claims. 
Sec. 303. Health claims for food products. 
Sec. 304. Nutrient content claims. 
Sec. 305. Referral statements. 
Sec. 306. Disclosure of irradiation. 
Sec. 307. Irradiation petition. 
Sec. 308. Glass and ceramic ware. 
Sec. 309. Food contact substances. 
TITLE rV—GENERAL PROVISIONS 
Sec. 401. Dissemination of information on new uses. 
Sec. 402. Expanded access to investigational therapies and diagnostics. 
Sec. 403. Approval of supplemental applications for approved products. 
Sec. 404. Dispute resolution. 
Sec. 405. Informal agency statements. 
Sec. 406. Food and Drug Administration mission and annual report. 
Sec. 407. Information system. 
Sec. 408. Education and training. 
Sec. 409. Centers for education and research on therapeutics. 
Sec. 410. Mutual recognition agreements and global harmonization. 
Sec. 411. Environmental impact review. 
Sec. 412. National uniformity for nonprescription drugs and cosmetics. 
Sec. 413. Food and Drug Administration study of mercury compounds in drugs and 
food. 
Sec. 414. Interagency collaboration. 
Sec. 415. Contracts for expert review. 
Sec. 416. Product classification. 
Sec. 417. Registration of foreign establishments. 
Sec. 418. Clarification of seizure authority. 
Sec. 419. Interstate commerce. 
Sec. 420. Safety report disclaimers. 
Sec. 421. Labeling and advertising regarding compliance with statutory require-
ments. 
Sec. 422. Rule of construction. 
TITLE V—EFFECTIVE DATE 
Sec. 501. Effective date. 
SEC. 2. DEFINrriONS. 
21 USC 321 note. 
In this Act, the terms "drug", "device", "food", and "dietary 
supplement" have the meaning given such terms in section 201 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 
I l l STAT. 2298 
PUBLIC LAW 105-115—NOV. 21, 1997 
TITLE I—IMPROVING REGULATION OF 
DRUGS 
Subtitle A—Fees Relating to Drugs 
21 use 379g 
SEC. 101. FINDINGS. 
'''^- 
Congress finds t h a t ^ 
(1) prompt approval of safe and effective new drugs and 
other therapies is critical to the improvement of the public 
health so that patients may enjoy the benefits provided by 
these therapies to treat and prevent illness and disease; 
(2) the public health will be served by making additional 
fiinds available for the purpose of augmenting the resources 
of the Food and Drug Administration that are devoted to the 
process for review of human drug applications.; 
(3) the provisions added by the Prescription Drug User 
Fee Act of 1992 have been successful in substantially reducing 
review times for human drug applications and should be— 
(A) reauthorized for an additional 5 years, with certain 
technical improvements; and 
(B) carried out by the Food and Drug Administration 
with new commitments to implement more ambitious and 
comprehensive improvements in regulatory processes of the 
Food and Drug Administration; and 
(4) the fees authorized by amendments made in this subtitle 
will be dedicated toward expediting the drug development proc-
ess and the review of humsin drug applications as set forth 
in the goals identified, for purposes of part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and Human 
Services to the chairman of the Committee on Commerce of 
the House of Representatives and the chairman of the Commit-
tee on Labor and Human Resources of the Senate, as set 
forth in the Congressional Record. 
SEC. 102. DEFINITIONS. 
Section 735 (21 U.S.C. 379g) is amended— 
(1) in the second sentence of paragraph (1)— 
(A) by striking "Service Act, and" and inserting "Service 
Act,"; and 
(B) by striking "September 1, 1992." and inserting 
the following: "September 1, 1992, does not include an 
application for a licensure of a biological product for further 
manufacturing use only, and does not include an applica-
tion or supplement submitted by a State or Federal Govern-
ment entity for a drug that is not distributed commercially. 
Such term does include an application for licensure, as 
described in subparagraph (D), of a large volume biological 
product intended for single dose injection for intravenous 
use or infusion."; 
(2) in the second sentence of paragraph (3)— 
(A) by striking "Service Act, and" and inserting "Service 
Act,"; and 
(B) by striking "September 1, 1992." and inserting 
the following: "September 1, 1992, does not include a 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2299 
biological product that is licensed for further manufacturing 
use only, and does not include a drug that is not distributed 
commercially and is the subject of an application or supple-
ment submitted by a State or Federal Government entity. 
Such term does include a large volume biological product 
intended for single dose injection for intravenous use or 
infusion."; 
(3) in paragraph (4), by striking "without" and inserting 
"without substantial"; 
(4) by amending the first sentence of paragraph (5) to 
read as follows: 
"(5) The term 'prescription drug establishment' means a 
foreign or domestic place of business which is at one general 
physical location consisting of one or more buildings all of 
which are within five miles of each other and at which one 
or more prescription drug products are manufactured in final 
dosage form."; 
(5) in paragraph (7)(A)— 
(A) by striking "employees under contract" and all 
that follows through "Administration," the second time it 
occurs and inserting "contractors of the Food and Drug 
Administration,"; and 
(B) by striking "and committees," and inserting "and 
committees eind to contracts with such contractors,"; 
(6) in paragraph (8)— 
(A) in subpgiragraph (A)— 
(i) by striking "August of" and inserting "April 
of"; and 
(ii) by striking "August 1992" and inserting "April 
1997"; and 
(B) in subparagraph (B)— 
(i) by striking "section 254(d)" and inserting "sec-
tion 254(c)"; 
(ii) by striking "1992" and inserting "1997"; and 
(iii) by striking "102d Congress, 2d Session" and 
inserting "105th Congress, 1st Session"; and 
(7) by adding at the end the following: 
"(9) The term 'affiliate' means a business entity that has 
a relationship with a second business entity if, directly or 
indirectly— 
"(A) one business entity controls, or has the power 
to control, the other business entity; or 
"(B) a third party controls, or has power to control, 
both of the business entities.". 
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 379h(a)) is 
amended— 
(1) by striking "Beginning in fiscal year 1993" and inserting 
"Beginning in fiscal year 1998"; 
(2) in paragraph (1)— 
(A) by striking subparagraph (B) and inserting the 
following: 
"(B) PAYMENT.—The fee required by subparagraph (A) 
shall be due upon submission of the application or supple-
ment."; 
(B) in subparagraph (D)— 
I l l STAT. 2300 
PUBLIC LAW 105-115—NOV. 21, 1997 
(i) in the subparagraph heading, by striking "NOT 
ACCEPTED" and inserting "REFUSED"; 
(ii) by striking "50 percent" and inserting "75 per-
cent"; 
(iii) by striking "subparagraph (B)(i)" and inserting 
"subparagraph (B) ; and 
(iv) by striking "not accepted" and 
inserting 
"refused"; and 
(C) by adding at the end the following: 
"(E) 
EXCEPTION FOR DESIGNATED ORPHAN DRUG OR 
INDICATION.—^A human drug application for a prescription 
drug product that has been designated as a drug for a 
rare disease or condition pursuant to section 526 shall 
not be subject to a fee under subparagraph (A), unless 
the human drug application includes an indication for other 
than a rare disease or condition. A supplement proposing 
to include a new indication for a rare disease or condition 
in a human drug application shall not be subject to a 
fee under subparagraph (A), if the drug has been des-
ignated pursuant to section 526 as a drug for a rare disease 
or condition with regard to the indication proposed in such 
supplement. 
"(F) 
EXCEPTION 
FOR 
SUPPLEMENTS 
FOR 
PEDIATRIC 
INDICATIONS.—^A supplement to a human drug application 
proposing to include a new indication for use in pediatric 
populations shall not be assessed a fee under subparagraph 
(A). 
"(G) 
REFUND OF FEE IF APPLICATION WITHDRAWN.— 
If an application or supplement is withdrawn after the 
application or supplement was filed, the Secretary may 
refund the fee or a portion of the fee if no substantial 
work was performed on the application or supplement after 
the application or supplement was filed. The Secretary 
shall have the sole discretion to refund a fee or a portion 
of the fee under this subparagraph. A determination by 
the Secretary concerning a remnd under this paragraph 
shall not be reviewable."; 
(3) by striking paragraph (2) and inserting the following: 
"(2) PRESCRIPTION DRUG ESTABLISHMENT FEE.— 
"(A) IN GENERAL.—Except as provided in subparagraph 
(B), each person that— 
"(i) is named as the applicant in a human drug 
application; and 
"(ii) after September 1, 1992, had pending before 
the Secretary a human drug application or supplement, 
shall be assessed an annual fee established in subsection 
(b) for each prescription drug establishment listed in its 
approved human drug application as an establishment that 
manufactures the prescription drug product named in the 
application. The sinnual establishment fee shall be assessed 
in each fiscal year in which the prescription drug product 
named in the application is assessed a fee luider paragraph 
(3) unless the prescription drug establishment listed in 
the application does not engage in the msinufacture of 
the prescription drug product during the fiscal year. The 
establishment fee shall be payable on or before January 
31 of each year. Each such establishment shall be assessed 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2301 
only one fee per establishment, notwithstanding the num-
ber of prescription drug products manufactured at the 
establishment. In the event an establishment is listed in 
a human drug application by more than one applicant, 
the establishment fee for the fiscal year shall be divided 
equally and assessed among the applicants whose prescrip-
tion drug products are manufactured by the establishment 
during the fiscal year and assessed product fees under 
paragraph (3). 
"(B) 
EXCEPTION.—If, 
during the fiscal year, an 
applicant initiates or causes to be initiated the manufacture 
of a prescription drug product at an establishment listed 
in its human drug application— 
"(i) that did not manufacture the product in the 
previous fiscal year; and 
"(ii) for which the full establishment fee has been 
assessed in the fiscal year at a time before manufacture 
of the prescription drug product was begun; 
the applicant will not be assessed a share of the establish-
ment fee for the fiscal year in which the manufacture 
of the product began."; and 
(4) in paragraph (3)— 
(A) in subparagraph (A)— 
(i) in clause (i), by striking "is listed" and inserting 
"has been submitted for listing'; and 
(ii) by striking "Such fee shall be payable" and 
all that follows through "section 510." and inserting 
the following: "Such fee shall be payable for the fiscal 
year in which the product is first submitted for listing 
under section 510, or is submitted for relisting under 
section 510 if the product has been withdrawn from 
listing and relisted. After such fee is paid for that 
fiscal year, such fee shall be payable on or before 
January 31 of each year. Such fee shall be paid only 
once for each product for a fiscal year in which the 
fee is payable."; and 
(B) in subparagraph (B), by striking "505(j)." and 
inserting the following: "505(j), under an abbreviated 
application filed under section 507 (as in effect on the 
day before the date of enactment of the Food and Drug 
Administration Modernization Act of 1997), or under an 
abbreviated new drug application pursuEint to regulations 
in effect prior to the implementation of the Drug Price 
Competition and Patent Term Restoration Act of 1984.". 
(b) FEE AMOUNTS.—Section 736(b) (21 U.S.C. 379h(b)) is amend-
ed to read as follows: 
"(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), 
(f), and (g), the fees required under subsection (a) shall be deter-
mined and assessed as follows: 
"(1) APPLICATION AND SUPPLEMENT FEES.— 
"(A) FULL FEES.—The application fee under subsection 
(a)(l)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 
in each of fiscal years 1999 and 2000, $267,606 in fiscal 
year 2001, and $258,451 in fiscal year 2002. 
"(B) 
OTHER 
FEES.—^The 
fee 
under 
subsection 
(a)(l)(A)(ii) shall be $125,352 in fiscal year 1998, $128,169 
I l l STAT. 2302 
PUBLIC LAW 105-115—NOV. 21, 1997 
in each of fiscal years 1999 and 2000, $133,803 in fiscal 
year 2001, and $129,226 in fiscal year 2002. 
"(2) TOTAL FEE REVENUES FOR ESTABLISHMENT FEES.—The 
total fee revenues to be collected in establishment fees under 
subsection (a)(2) shall be $35,600,000 in fiscal year 1998, 
$36,400,000 in each of fiscal years 1999 and 2000, $38,000,000 
in fiscal year 2001, and $36,700,000 in fiscal year 2002. 
"(3) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total 
fee revenues to be collected in product fees under subsection 
(a)(3) in a fiscal year shall be equal to the total fee revenues 
collected in establishment fees under subsection (a)(2) in that 
fiscal year.". 
(c) INCREASES AND ADJUSTMENTS.—Section 736(c) (21 U.S.C. 
379h(c)) is amended— 
(1) in the subsection heading, by striking "INCREASES AND"; 
(2) in paragraph (1)— 
(A) by striking "(1) REVENUE" and all that follows 
through "increased by the Secretary" and inserting the 
following: "(1) INFLATION ADJUSTMENT.—The fees and total 
fee revenues established in subsection (b) shall be adjusted 
by the Secretarj^'; 
(B) in subparagraph (A), by striking "increase" and 
inserting "change"; 
(C) in subparagraph (B), by striking "increase" and 
inserting "change"; and 
(D) by adding at the end the following flush sentence: 
"The adjustment made each fiscal year by this subsection will 
be added on a compounded basis to the sum of all adjustments 
made each fiscal year after fiscal year 1997 under this sub-
section."; 
(3) in paragraph (2), by striking "October 1, 1992," and 
all that follows through "such schedule." and inserting the 
following: "September 30, 1997, adjust the establishment and 
product fees described in subsection (b) for the fiscal year 
in which the adjustment occurs so that the revenues collected 
fi-om each of the categories of fees described in paragraphs 
(2) and (3) of subsection (b) shall be set to be equal to the 
revenues collected from the category of application and supple-
ment fees described in paragraph (1) of subsection (b)."; and 
(4) in paragraph (3), by striking "paragraph (2)" and insert-
ing "this subsection", 
(d) FEE WAIVER OR REDUCTION.—Section 736(d) (21 U.S.C. 
379h(d)) is amended— 
(1) by redesignating paragraphs (1), (2), (3), and (4) as 
subparagraphs (A), (B), (C), and (D), respectively and indenting 
appropriately; 
(2) by striking "The Secretary shsdl grant a" and all that 
follows through "finds that—" and inserting the following: 
"(1) IN GENERAL.—The Secretary shall grant a waiver from 
or a reduction of one or more fees assessed under subsection 
(a) where the Secretary finds that—"; 
(3) in subparagraph (C) (as so redesignated in paragraph 
(1)), by striking ", or" and inserting a comma; 
(4) in subparagraph (D) (as so redesignated in paragraph 
(1)), by striking the period and inserting ", or"; 
(5) by inserting after subparagraph (D) (as so redesignated 
in paragraph (1)) the following: 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2303 
"(E) the applicant involved is a small business submit-
ting its first human drug application to the Secretary for 
review."; and 
(6) by striking "In making the finding in paragraph (3)," 
and all that follows through "standard costs." and inserting 
the following: 
"(2) USE OF STANDARD COSTS.—In making the finding in 
paragraph (1)(C), the Secretary may use standard costs. 
"(3) RULES RELATING TO SMALL BUSINESSES.— 
"(A) DEFINITION.—In paragraph (1)(E), the term 'small 
business' means an entity that has fewer than 500 employ-
ees, including employees of affiliates. 
"(B) WAIVER OF APPLICATION FEE.—The Secretary shall 
waive under paragraph (1)(E) the application fee for the 
first human drug application that a small business or its 
affiliate submits to the Secretary for review. After a small 
business or its affiliate is gramted such a waiver, the small 
business or its affiliate shall pay— 
"(i) application fees for all subsequent human drug 
applications submitted to the Secretary for review in 
the same manner as an entity that does not qualify 
as a small business; and 
"(ii) all supplement fees for all supplements to 
human drug applications submitted to the Secretary 
for review in the same manner as an entity that does 
not qualify as a small business.". 
(e) 
ASSESSMENT 
OF FEES.—Section 736(f)(1) (21 U.S.C. 
379h(f)(l)) is amended— 
(1) by striking "fiscal year 1993" and inserting "fiscal year 
1997"; and 
(2) by striking "fiscal year 1992" and inserting "fiscal year 
1997 (excluding the amount of fees appropriated for such fiscal 
year)". 
(f) CREDITING AND AVAILABILITY OF FEES.—Section 736(g) (21 
U.S.C. 379h(g)) is amended— 
(1) in paragraph (1), by adding at the end the following: 
"Such sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and expenses appro-
priation account without fiscal year limitation to such appro-
priation account for salaries and expenses with such fiscal 
year limitation. The sums transferred shall be available solely 
for the process for the review of human drug applications."; 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking "Acts" and insert-
ing "Acts, or otherwise made available for obligation,"; and 
(B) in subparagraph (B), by striking "over such costs 
for fiscal year 1992 and inserting "over such costs, exclud-
ing costs paid fi*om fees collected under this section, for 
fiscal year 1997"; and 
(3) by striking paragraph (3) and inserting the following: 
"(3) 
AUTHORIZATION 
OF 
APPROPRIATIONS.—There 
are 
authorized to be appropriated for fees under this section— 
"(A) $106,800,000 for fiscal year 1998; 
"(B) $109,200,000 for fiscal year 1999; 
"(C) $109,200,000 for fiscal year 2000; 
"(D) $114,000,000 for fiscal year 2001; and 
"(E) $110,100,000 for fiscal year 2002, 
I l l STAT. 2304 
PUBLIC LAW 105-115—NOV. 21, 1997 
as adjusted to reflect adjustments in the total fee revenues 
made under this section and changes in the total amounts 
collected by application, supplement, establishment, and prod-
uct fees. 
"(4) OFFSET.—^Any amount of fees collected for a fiscal 
year under this section that exceeds the amount of fees specified 
in appropriation Acts for such fiscal year shall be credited 
to the appropriation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be subtracted 
from the amount of fees that would otherwise be authorized 
to be collected under this section pursuant to appropriation 
Acts for a subsequent fiscal year.", 
(g) REQUIREMENT FOR WRITTEN 
REQUESTS FOR WAIVERS, 
REDUCTIONS, AND REFUNDS.—Section 736 (21 U.S.C. 379h) is 
amended— 
(1) by redesignating subsection (i) as subsection Q); and 
(2) by inserting after subsection (h) the following: 
"(i) WRITTEN 
REQUESTS FOR WAIVERS, 
REDUCTIONS, AND 
REFUNDS.—^To qualify for consideration for a waiver or reduction 
under subsection (d), or for a refund of any fee collected in accord-
ance with subsection (a), a person shall submit to the Secretary 
a written request for such waiver, reduction, or refund not later 
than 180 days after such fee is due.". 
2iusc379h 
(h) SPECIAL RULE FOR WAIVERS AND REFUNDS.—Any requests 
note. 
for waivers or refunds for fees assessed under section 736 of the 
Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to 
the date of enactment of this Act shall be submitted in writing 
to the Secretary of Health and Human Services within 1 year 
after the date of enactment of this Act. Any requests for waivers 
or refunds pertaining to a fee for a human drug application or 
supplement accepted for filing prior to October 1, 1997 or to a 
product or establishment fee required by such Act for a fiscal 
year prior to fiscal year 1998, shall be evaluated according to 
the terms of the Prescription Drug User Fee Act of 1992 (as in 
effect on September 30, 1997) and part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (as in effect 
on September 30, 1997). The term "person" in such Acts shall 
continue to include an affiliate thereof. 
21 use 379g 
SEC. 104. ANNUAL REPORTS. 
"°^' 
(a) PERFORMANCE REPORT.—^Beginning with fiscal year 1998, 
not later than 60 days after the end of each fiscal year during 
which fees are collected under part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g 
et seq.), the Secretary of Health and Human Services shall prepare 
and submit to the Committee on Commerce of the House of Rep-
resentatives and the Committee on Labor and Human Resources 
of the Senate a report concerning the progress of the Food and 
Drug Administration in achieving the goals identified in the letters 
described in section 101(4) during such fiscal year and the future 
plans of the Food and Drug Administration for meeting the goals, 
(b) FISCAL REPORT,—Beginning with fiscal year 1998, not later 
than 120 days after the end of each fiscal year during which 
fees are collected under the part described in subsection (a), the 
Secretary of Health and Human Services shall prepare and submit 
to the Committee on Commerce of the House of Representatives 
and the Committee on Labor and Human Resources of the Senate 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2305 
a report on the implementation of the authority for such fees 
during such fiscal year and the use, by the Food and Drug Adminis-
tration, of the fees collected during such fiscal year for which 
the report is made. 
SEC. 105. SAVINGS. 
21USC 379g 
Notwithstanding section 105 of the Prescription Drug User 
Fee Act of 1992, the Secretary shall retain the authority to assess 
and collect any fee required by part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act for a human 
drug application or supplement accepted for filing prior to October 
1, 1997, and to assess and collect any product or establishment 
fee required by such Act for a fiscal year prior to fiscal year 
1998. 
SEC. 106. EFFECTIVE DATE. 
21USC379g 
The amendments made by this subtitle shall take effect October 
1, 1997. 
SEC. 107. TERMINATION OF EFFECTIVENESS. 
21USC379g 
The amendments made by sections 102 and 103 cease to be 
effective October 1, 2002, and section 104 ceases to be effective 
120 days after such date. 
Subtitle B—Other Improvements 
SEC. 111. PEDLVTRIC STUDIES OF DRUGS. 
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting 
after section 505 the following: 
"SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 
21 USC 355a. 
"(a) MARKET 
EXCLUSIVITY 
FOR 
NEW DRUGS.—If, prior to 
approval of an application that is submitted under section 505(b)(1), 
the Secretary determines that information relating to the use of 
a new drug in the pediatric population may produce health benefits 
in that population, the Secretary makes a written request for pedi-
atric studies (which shall include a timeframe for completing such 
studies), and such studies are completed within any such timeframe 
and the reports thereof submitted in accordance with subsection 
(d)(2) or accepted in accordance with subsection (d)(3)— 
"(l)(A)(i) the period referred to in subsection (c)(3)(D)(ii) 
of section 505, and in subsection (j)(4)(D)(ii) of such section, 
is deemed to be five years and six months rather than five 
years, and the references in subsections (c)(3)(D)(ii) and 
(j)(4)(D)(ii) of such section to four years, to forty-eight months, 
and to seven and one-half years are deemed to be four and 
one-half years, fifty-four months, and eight years, respectively; 
or 
"(ii) the period referred to in clauses (iii) and (iv) of sub-
section (c)(3)(D) of such section, and in clauses (iii) and (iv) 
of subsection (j)(4)(D) of such section, is deemed to be three 
years and six months rather than three years; and 
"(B) if the drug is designated under section 526 for a 
rare disease or condition, the period referred to in section 
527(a) is deemed to be seven years and six months rather 
than seven years; and 
"(2)(A) if the drug is the subject of— 
I l l STAT. 2306 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(i) a listed patent for which a certification has been 
submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
of section 505 and for which pediatric studies were submit-
ted prior to the expiration of the patent (including any 
patent extensions); or 
"(ii) a listed patent for which a certification has been 
submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) 
of section 505, 
the period during which an application may not be approved 
under section 505(c)(3) or section 505(j)(4)(B) shall be extended 
by a period of six months after the date the patent expires 
(including any patent extensions); or 
"(B) if the drug is the subject of a listed patent for which 
a certification has been submitted under subsection (b)(2)(A)(iv) 
or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringe-
ment litigation resulting from the certification the court deter-
mines that the patent is valid and would be infi*inged, the 
period during which an application may not be approved under 
section 505(c)(3) or section 505(j)(4)(B) shall be extended by 
a period of six months after the date the patent expires (includ-
ing any patent extensions), 
"(b) SECRETARY TO DEVELOP LIST OF DRUGS FOR WHICH ADDI-
TIONAL PEDIATRIC INFORMATION MAY BE BENEFICIAL.—Not later 
than 180 days after the date of enactment of the Food and Drug 
Administration Modernization Act of 1997, the Secretary, after con-
sultation with experts in pediatric research shall develop, prioritize, 
and publish an initial list of approved drugs for which additional 
pediatric information may produce health benefits in the pediatric 
population. The Secretary shall annually update the list. 
"(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.— 
If the Secretary makes a written request to the holder of an 
approved application under section 505(b)(1) for pediatric studies 
(which shall include a timefi-ame for completing such studies) 
concerning a drug identified in the list described in subsection 
(b), the holder agrees to the request, the studies are completed 
within any such timefi*ame, and the reports thereof are submitted 
in accordance with subsection (d)(2) or accepted in accordance with 
subsection (d)(3)— 
"(l)(A)(i) the period referred to in subsection (c)(3)(D)(ii) 
of section 505, and in subsection (j)(4)(D)(ii) of such section, 
is deemed to be five years and six months rather than five 
years, and the references in subsections (c)(3)(D)(ii) and 
(j)(4)(D)(ii) of such section to four years, to forty-eight months, 
and to seven and one-half years are deemed to be four and 
one-half years, fifty-four months, and eight years, respectively; 
or 
"(ii) the period referred to in clauses (iii) and (iv) of sub-
section (c)(3)(D) of such section, and in clauses (iii) and (iv) 
of subsection (j)(4)(D) of such section, is deemed to be three 
years and six months rather than three years; and 
"(B) if the drug is designated under section 526 for a 
rare disease or condition, the period referred to in section 
527(a) is deemed to be seven years and six months rather 
than seven years; and 
"(2)(A) if the drug is the subject of— 
"(i) a listed patent for which a certification has been 
submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2307 
of section 505 and for which pediatric studies were submit-
ted prior to the expiration of the patent (including any 
patent extensions); or 
"(ii) a Usted patent for which a certification has been 
submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) 
of section 505, 
the period during which an appUcation may not be approved 
under section 505(c)(3) or section 505(j)(4)(B) shall be extended 
by a period of six months after the date the patent expires 
(including any patent extensions); or 
"(B) if the drug is the subject of a listed patent for which 
a certification has been submitted under subsection (b)(2)(A)(iv) 
or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringe-
ment litigation resulting from the certification the court deter-
mines that the patent is valid and would be infringed, the 
period during which an application may not be approved under 
section 505(c)(3) or section 505(j)(4)(B) shall be extended by 
a period of six months after the date the patent expires (includ-
ing any patent extensions). 
"(d) CONDUCT OF PEDIATRIC STUDIES.— 
"(1) AGREEMENT FOR STUDIES.—The Secretary may, pursu-
ant to a written request from the Secretary under subsection 
(a) or (c), after consultation with— 
"(A) the sponsor of an application for an investigational 
new drug under section 505(i); 
"(B) the sponsor of an application for a new drug 
under section 505(b)(1); or 
"(C) the holder of an approved application for a drug 
under section 505(b)(1), 
agree with the sponsor or holder for the conduct of pediatric 
studies for such drug. Such agreement shall be in writing 
and shall include a timeframe for such studies. 
"(2) WRITTEN PROTOCOLS TO MEET THE STUDIES REQUIRE-
MENT.—If the sponsor or holder and the Secretary agree upon 
written protocols for the studies, the studies requirement of 
subsection (a) or (c) is satisfied upon the completion of the 
studies and submission of the reports thereof in accordance 
with the original written request and the written agreement 
referred to in paragraph (1). Not later than 60 days after 
the submission of the report of the studies, the Secretary shall 
determine if such studies were or were not conducted in accord-
ance with the original written request and the written agree-
ment and reported in accordance with the requirements of 
the Secretary for filing and so notify the sponsor or holder. 
"(3) OTHER METHODS TO MEET THE STUDIES REQUIREMENT.— 
If the sponsor or holder and the Secretary have not agreed 
in writing on the protocols for the studies, the studies require-
ment of subsection (a) or (c) is satisfied when such studies 
have been completed and the reports accepted by the Secretary. 
Not later than 90 days after the submission of the reports 
of the studies, the Secretary shall accept or reject such reports 
and so notify the sponsor or holder. The Secretary's only respon-
sibility in accepting or rejecting the reports shall be to deter-
mine, within the 90 days, whether the studies fairly respond 
to the written request, have been conducted in accordance 
with commonly accepted scientific principles and protocols, and 
H I STAT. 2308 
PUBLIC LAW 105-115—NOV. 21, 1997 
have been reported in accordance with the requirements of 
the Secretary for filing. 
"(e) DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION.— 
If the Secretary determines that the acceptance or approval of 
an application under section 505(b)(2) or 505(j) for a new drug 
may occur after submission of reports of pediatric studies under 
this section, which were submitted prior to the expiration of the 
patent (including einy patent extension) or the applicable period 
under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses 
(ii) through (iv) of section 5050*)(4)(D), but before the Secretary 
has determined whether the requirements of subsection (d) have 
been satisfied, the Secretary shall delay the acceptsince or approval 
under section 505(b)(2) or 505(j) until the determination under 
subsection (d) is made, but any such delay shall not exceed 90 
days. In the event that requirements of this section are satisfied, 
the applicable six-month period under subsection (a) or (c) shall 
be deemed to have been running during the period of delay. 
"(f) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.— 
The Secretary shall publish a notice of any determination that 
the requirements of subsection (d) have been met and that submis-
sions and approvals under subsection (b)(2) or (j) of section 505 
for a drug will be subject to the provisions of this section. 
"(g) DEFINITIONS.—As used in this section, the term 'pediatric 
studies' or 'studies' means at least one clinical investigation (that, 
at the Secretary's discretion, may include pharmacokinetic studies) 
in pediatric age groups in which a drug is anticipated to be used. 
"(h) LIMITATIONS.—^A drug to which the six-month period imder 
subsection (a) or (b) has already been applied— 
"(1) may receive an additional six-month period under sub-
section (c)(l)(A)(ii) for a supplemental application if all other 
requirements under this section are satisfied, except that such 
a drug may not receive any additional such period under sub-
section (c)(2); and 
"(2) may not receive any additional such period under 
subsection (c)(1)(B). 
"(i) 
RELATIONSHIP TO REGULATIONS.—Notwithstanding 
any 
other provision of law, if any pediatric study is required pursuant 
to regulations promulgated by the Secretary and such study meets 
the completeness, timeliness, £ind other requirements of this section, 
such study shall be deemed to satisfy the requirement for market 
exclusivity pursuant to this section. 
"(j) SUNSET.—^A drug may not receive any six-month period 
under subsection (a) or (c) unless the application for the drug 
under section 505(b)(1) is submitted on or before January 1, 2002. 
After January 1, 2002, a drug shall receive a six-month period 
under subsection (c) if— 
"(1) the drug was in commercial distribution as of the 
date of enactment of the Food and Drug Administration Mod-
ernization Act of 1997; 
"(2) the drug was included by the Secretary on the list 
imder subsection (b) as of January 1, 2002; 
"(3) the Secretary determines that there is a continuing 
need for information relating to the use of the drug in the 
pediatric population and that the drug may provide health 
benefits in that population; and 
"(4) all requirements of this section are met. 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2309 
"(k) REPORT.—The Secretary shall conduct a study and report 
to Congress not later than January 1, 2001, based on the experience 
under the program established under this section. The study and 
report shall examine all relevant issues, including— 
"(1) the effectiveness of the program in improving informa-
tion about important pediatric uses for approved drugs; 
"(2) the adequacy of the incentive provided under this 
section; 
"(3) the economic impact of the program on taxpayers and 
consumers, including the impact of the lack of lower cost generic 
drugs on patients, including on lower income patients; and 
"(4) any suggestions for modification that the Secretary 
determines to be appropriate.". 
SEC. 112. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS. 
(a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.), as amended 
by section 125, is amended by inserting before section 508 the 
following: 
"SEC. 506. FAST TRACK PRODUCTS. 
21USC 356. 
"(a) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT.— 
"(1) IN GENERAL.—The Secretary shall, at the request of 
the sponsor of a new drug, facilitate the development and 
expedite the review of such drug if it is intended for the 
treatment of a serious or life-threatening condition and it dem-
onstrates the potential to address unmet medical needs for 
such a condition. (In this section, such a drug is referred 
to as a 'fast track product'.) 
"(2) REQUEST FOR DESIGNATION.—The sponsor of a 
new 
drug may request the Secretary to designate the drug as a 
fast track product. A request for the designation may be made 
concurrently with, or at any time after, submission of an 
application for the investigation of the drug under section 505(i) 
or section 351(a)(3) of the Public Health Service Act. 
"(3) DESIGNATION.—Within 60 calendar days after the 
receipt of a request under paragraph (2), the Secretary shall 
determine whether the drug that is the subject of the request 
meets the criteria described in paragraph (1). If the Secretary 
finds that the drug meets the criteria, the Secretary shall 
designate the drug as a fast track product and shall take 
such actions as are appropriate to expedite the development 
and review of the application for approval of such product. 
"(b) APPROVAL OF APPLICATION FOR A FAST TRACK PRODUCT.— 
"(1) IN GENERAL.—The Secretary may approve an applica-
tion for approval of a fast track product under section 505(c) 
or section 351 of the Public Health Service Act upon a deter-
mination that the product has an effect on a clinical endpoint 
or on a surrogate endpoint that is reasonably likely to predict 
clinical benefit. 
"(2) LIMITATION.—Approval of a fast track product under 
this subsection may be subject to the requirements— 
"(A) that the sponsor conduct appropriate post-approval 
studies to validate the surrogate endpoint or otherwise 
confirm the effect on the clinical endpoint; and 
"(B) that the sponsor submit copies of all promotional 
materials related to the fast track product during the 
preapproval review period and, following approval and for 
such period thereafter as the Secretary determines to be 
I l l STAT. 2310 
PUBLIC LAW 105-115—NOV. 21, 1997 
appropriate, at least 30 days prior to dissemination of 
the materials. 
"(3) EXPEDITED WITHDRAWAL OF APPROVAL.—The Secretary 
may withdraw approval of a fast track product using expedited 
procedures (as prescribed by the Secretary in regulations which 
shall include an opportunity for an informal hearing) if— 
"(A) the sponsor fails to conduct any required post-
approval study of the fast track drug with due diligence; 
"(B) a post-approval study of the fast track product 
fails to verify clinical benefit of the product; 
"(C) other evidence demonstrates that the fast track 
product is not safe or effective under the conditions of 
use; or 
"(D) the sponsor disseminates false or misleading pro-
motional materials with respect to the product. 
"(c) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF 
A FAST TRACK PRODUCT.— 
"(1) IN GENERAL.—If the Secretary determines, 
after 
preliminary evaluation of clinical data submitted by the spon-
sor, that a fast track product may be effective, the Secretary 
shall evaluate for filing, and may commence review of portions 
of, an application for the approval of the product before the 
sponsor submits a complete application. The Secretary shall 
commence such review only if the applicant— 
"(A) provides a schedule for submission of information 
necessary to make the application complete; and 
"(B) pays any fee that may be required under section 
736. 
"(2) EXCEPTION.—^Any time period for review of human 
drug applications that has been agreed to by the Secretary 
and that has been set forth in goals identified in letters of 
the Secretary (relating to the use of fees collected under section 
736 to expedite the drug development process and the review 
of human drug applications) shall not apply to an application 
submitted under paragraph (1) until the date on which the 
application is complete. 
"(d) AWARENESS EFFORTS.—The Secretary shall— 
"(1) develop and disseminate to physicians, 
patient 
organizations, pharmaceutical and biotechnology companies, 
and other appropriate persons a description of the provisions 
of this section applicable to fast track products; and 
"(2) establish a program to encourage the development 
of surrogate endpoints that are reasonably likely to predict 
clinical benefit for serious or life-threatening conditions for 
which there exist significant unmet medical needs.". 
21 use 356 note. 
(b) GUIDANCE.—Within 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall 
issue guidance for fast track products (as defined in section 506(a)(1) 
of the Federal Food, Drug, and Cosmetic Act) that describes the 
policies and procedures that pertain to section 506 of such Act. 
SEC. 113. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERI-
OUS OR LIFE-THREATENING DISEASES. 
(a) IN GENERAL.—Section 402 of the Public Health Service 
Act (42 U.S.C. 282) is amended— 
(1) by redesignating subsections (j) and (k) as subsections 
(k) and (1), respectively; and 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2311 
(2) by inserting after subsection (i) the following: 
"(j)(l)(A) The Secretary, acting through the Director of NIH, Establishment. 
shall estalDlish, maintain, and operate a data bank of information 
on clinical trials for drugs for serious or life-threatening diseases 
£ind conditions (in this subsection referred to as the 'data bank'). 
The activities of the data bank shall be integrated and coordinated 
with related activities of other agencies of the Department of Health 
and Human Services, and to the extent practicable, coordinated 
with other data banks containing similar information. 
"(B) The Secretary shall establish the data bank after consulta-
tion with the Commissioner of Food and Drugs, the directors of 
the appropriate agencies of the National Institutes of Health 
(including the National Library of Medicine), and the Director of 
the Centers for Disease Control and Prevention. 
"(2) In carrying out paragraph (1), the Secretary shall collect, 
catalog, store, and disseminate the information described in such 
paragraph. The Secretary shall disseminate such information 
through information systems, which shall include toll-free telephone 
commxinications, available to individuals with serious or life-
threatening diseases £ind conditions, to other members of the public, 
to health care providers, and to researchers. 
"(3) The data bank shall include the following: 
"(A) A registry of clinical trials (whether federally or pri-
vately funded) of experimental treatments for serious or life-
threatening diseases and conditions imder regulations promul-
gated pursuant to section 505(i) of the Federal Food, Drug, 
and Cosmetic Act, which provides a description of the purpose 
of each experimental drug, either with the consent of the proto-
col sponsor, or when a trial to test effectiveness begins. Informa-
tion provided shall consist of eligibility criteria for participation 
in the clinical trials, a description of the location of trial sites, 
and a point of contact for those wanting to enroll in the trial, 
and shall be in a form that can be readily understood by 
members of the public. Such information shall be forwarded 
to the data bank by the sponsor of the trial not later than 
21 days after the approval of the protocol. 
"(B) Information pertaining to experimental treatments for 
serious or life-threatening diseases and conditions that may 
be available— 
"(i) under a treatment investigational new drug 
application that has been submitted to the Secretary under 
section 561(c) of the Federal Food, Drug, and Cosmetic 
Act; or 
"(ii) as a Group C cancer drug (as defined by the 
National Cancer Institute). 
The data bank may also include information pertaining to 
the results of clinical trials of such treatments, with the consent 
of the sponsor, including information concerning potential 
toxicities or adverse effects associated with the use or adminis-
tration of such experimental treatments. 
"(4) The data bank shall not include information relating to 
an investigation if the sponsor has provided a detailed certification 
to the Secretary that disclosure of such information would substan-
tially interfere with the timely enrollment of subjects in the inves-
tigation, unless the Secretary, after the receipt of the certification, 
provides the sponsor with a detailed written determination that 
Ill STAT. 2312 
PUBLIC LAW 105-115—NOV. 21, 1997 
such disclosure would not substantially interfere with such enroll-
ment. 
Appropriation 
"(5) For the purpose of carr3dng out this subsection, there 
authorization. 
are authorized to be appropriated such sums as may be necessary. 
Fees collected under section 736 of the Federal Food, Drug, and 
Cosmetic Act shall not be used in carrying out this subsection.". 
42 use 282 note. 
(b) COLLABORATION AND REPORT.— 
(1) IN GENERAL.—The Secretary of Health and Human 
Services, the Director of the National Institutes of Health, 
and the Commissioner of Food and Drugs shall collaborate 
to determine the feasibility of including device investigations 
within the scope of the data bank under section 402(j) of the 
Public Health Service Act. 
(2) REPORT.—Not later than two years after the date of 
enactment of this section, the Secretary of Health and Human 
Services shall prepare and submit to the Committee on Labor 
£md Human Resources of the Senate and the Committee on 
Commerce of the House of Representatives a report— 
(A) of the public health need, if any, for inclusion 
of device investigations within the scope of the data bank 
under section 402(j) of the Public Health Service Act; 
(B) on the adverse impact, if any, on device innovation 
and research in the United States if information relating 
to such device investigations is required to be publicly 
disclosed; and 
(C) on such other issues relating to such section 402(j) 
as the Secretary determines to be appropriate. 
SEC. 114. HEALTH CARE ECONOMIC INFORMATION. 
(a) IN GENERAL.—Section 502(a) (21 U.S.C. 352(a)) is amended 
by adding at the end the following: "Health care economic informa-
tion provided to a formulary committee, or other similar entity, 
in the course of the committee or the entity carrying out its respon-
sibilities for the selection of drugs for managed care or other similar 
organizations, shall not be considered to be false or misleading 
under this paragraph if the health care economic information 
directly relates to an indication approved under section 505 or 
under section 351(a) of the Public Health Service Act for such 
drug and is based on competent and reliable scientific evidence. 
The requirements set forth in section 505(a) or in section 351(a) 
of the Public Health Service Act shall not apply to health care 
economic information provided to such a committee or entity in 
accordance with this paragraph. Information that is relevant to 
the substantiation of the health care economic information pre-
sented pursuant to this paragraph shall be made available to the 
Secretary upon request. In this paragraph, the term ^health care 
economic information' means any analysis that identifies, measures, 
or compares the economic consequences, including the costs of the 
represented health outcomes, of the use of a drug to the use of 
another drug, to another health care intervention, or to no interven-
tion.". 
21 use 352 note. 
(b) STUDY AND REPORT.—The Comptroller General of the United 
States shall conduct a study of the implementation of the provisions 
added by the amendment made by subsection (a). Not later than 
4 years and 6 months after the date of enactment of this Act, 
the Comptroller General of the United States shall prepare and 
submit to Congress a report containing the findings of the study. 
•%&\J^-' 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2313 
SEC. 115. CLINICAL INVESTIGATIONS. 
(a) CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
INVESTIGATIONS FOR APPROVAL.—Section 505(d) (21 U.S.C. 355(d)) 
is amended by adding at the end the following: "If the Secretary 
determines, based on relevan G science, that data from one adequate 
and well-controlled clinical investigation and confirmatory evidence 
(obtained prior to or after such investigation) are sufficient to 
establish effectiveness, the Secretary may consider such data and 
evidence to constitute substantial evidence for purposes of the 
preceding sentence.". 
(b) WOMEN AND MINORITIES.—Section 505(b)(1) (21 U.S.C. 
355(b)(1)) is amended by adding at the end the following: "The 
Secretary shall, in consultation with the Director of the National 
Institutes of Health and with representatives of the drug manufac-
turing industry, review and develop guidance, as appropriate, on 
the inclusion of women and minorities in clinical trials required 
by clause (A).". 
SEC. 
1
1
6
. 
MANUFACTURING 
CHANGES 
FOR 
DRUGS. 
(a) IN GENERAL.—Chapter V, as amended by section 112, is 
amended by inserting after section 506 the following section: 
"SEC. 506A. MANUFACTURING CHANGES. 
21 USC 356a. 
"(a) IN GENERAL.—^With respect to a drug for which there 
is in effect an approved application imder section 505 or 512 or 
a license under section 351 of the Public Health Service Act, a 
change from the msinufacturing process approved pursuant to such 
application or license may be made, and the drug as made with 
the chsmge may be distributed, if— 
"(1) the holder of the approved application or license 
(referred to in this section as a Tiolder') has validated the 
effects of the change in accordance with subsection (b); and 
"(2)(A) in the case of a major manufacturing change, the 
holder has complied with the requirements of subsection (c); 
or 
"(B) in the case of a change that is not a major manufactur-
ing change, the holder complies with the applicable require-
ments of subsection (d). 
"(b) VALIDATION OF EFFECTS OF CHANGES.—For purposes of 
subsection (a)(1), a drug made with a manufacturing change 
(whether a major manufacturing change or otherwise) may be 
distributed only if, before distribution of the drug as so made, 
the holder involved validates the effects of the change on the iden-
tity, strength, quality, purity, and potency of the drug as the iden-
tity, strength, quality, purity, and potency may relate to the safety 
or effectiveness of the drug. 
"(c) MAJOR MANUFACTURING CHANGES.— 
"(1) 
REQUIREMENT OF SUPPLEMENTAL APPLICATION.—For 
purposes of subsection (a)(2)(A), a drug made with a major 
manufacturing change may be distributed only if, before the 
distribution of the drug as so made, the holder involved submits 
to the Secretary a supplemental application for such change 
and the Secretary approves the application. The application 
shall contain such information as the Secretary determines 
to be appropriate, and shall include the information developed 
under subsection (b) by the holder in validating the effects 
of the change. 
39-194 O - 97 - 8 : QL 3 Part 3 
I l l STAT. 2314 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(2) CHANGES QUALIFYING AS MAJOR CHANGES.—For pur-
poses of subsection (a)(2)(A), a major manufacturing change 
is a manufacturing change that is determined by the Secretary 
to have substantial potential to adversely affect the identity, 
strength, quality, purity, or potency of the drug as they may 
relate to the safety or effectiveness of a drug. Such a change 
includes a change that— 
"(A) is made in the qualitative or quantitative formula-
tion of the drug involved or in the specifications in the 
approved application or license referred to in subsection 
(a) for the drug (unless exempted by the Secretary by 
regulation or guidance from the requirements of this sub-
section); 
"(B) is determined by the Secretary by regulation or 
guidance to require completion of an appropriate clinical 
study demonstrating equivalence of the drug to the drug 
as manufactured without the change; or 
"(C) is another type of change determined by the Sec-
retary by regulation or guidance to have a substantial 
potential to adversely affect the safety or effectiveness of 
the drug. 
"(d) OTHER MANUFACTURING CHANGES.— 
"(1) IN GENERAL.—For purposes of subsection (a)(2)(B), the 
Secretary may regulate drugs made with 
manufacturing 
changes that are not major manufacturing changes as follows: 
"(A) The Secretary may in accordance with paragraph 
(2) authorize holders to distribute such drugs without 
submitting a supplemental application for such changes. 
"(B) The Secretary may in accordance with paragraph 
(3) require that, prior to the distribution of such drugs, 
holders submit to the Secretary supplemental applications 
for such changes. 
"(C) The Secretary may establish categories of such 
changes and designate categories to which subparagraph 
(A) applies and categories to which subparagraph (B) 
applies. 
"(2) 
CHANGES NOT REQUIRING SUPPLEMENTAL APPLICA-
TION.— 
"(A) SUBMISSION 
OF REPORT.—A holder making a 
manufacturing change to which paragraph (1)(A) applies 
shall submit to the Secretary a report on the change, 
which shall contain such information as the Secretary 
determines to be appropriate, and which shall include the 
information developed under subsection (b) by the holder 
in validating the effects of the chemge. The report shall 
be submitted by such date as the Secretary may specify. 
"(B) AUTHORITY REGARDING ANNUAL REPORTS.—In the 
case of a holder that during a single year makes more 
than one manufacturing change to which paragraph (1)(A) 
applies, the Secretary may in carrying out subparagraph 
(A) authorize the holder to comply with such subparagraph 
by submitting a single report for the year that provides 
the information required in such subparagraph for all the 
changes made by the holder during the year. 
"(3) CHANGES REQUIRING SUPPLEMENTAL APPLICATION.— 
"(A) SUBMISSION OF SUPPLEMENTAL APPLICATION.—The 
supplemental application required under paragraph (1)(B) 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2315 
for a manufacturing change shall contain such information 
as the Secretary determines to be appropriate, which shall 
include the information developed under subsection (b) by 
the holder in validating the effects of the change. 
"(B) AUTHORITY FOR DISTRIBUTION.—In the case of a 
manufacturing change to which paragraph (1)(B) applies: 
"(i) The holder involved may commence distribu-
tion of the drug involved 30 days after the Secretary 
receives the supplemental application under such para-
graph, unless the Secretary notifies the holder within 
such 30-day period that prior approval of the applica-
tion is required before distribution may be commenced, 
"(ii) The Secretary may designate a category of 
such changes for the purpose of providing that, in 
the case of a change that is in such category, the 
holder involved may commence distribution of the drug 
involved upon the receipt by the Secretary of a supple-
mental application for the change. 
"(iii) If the Secretary disapproves the supplemental 
application, the Secretary may order the manufacturer 
to cease the distribution of the drugs that have been 
made with the manufacturing change.", 
(b) TRANSITION RULE.—The amendment made by subsection 
21 use 356a 
(a) takes effect upon the effective date of regulations promulgated note. 
by the Secretary of Health and Human Services to implement 
such amendment, or upon the expiration of the 24-month period 
beginning on the date of the enactment of this Act, whichever 
occurs first. 
SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS. 
Section 505(i) (21 U.S.C. 355(i)) is amended— 
(1) by redesignating paragraphs (1) through (3) as subpara-
graphs (A) through (C), respectively; 
(2) by inserting "(1)" after "(i)"; 
(3) by striking the last two sentences; and 
(4) by inserting after paragraph (1) (as designated by para-
graph (2) of this section) the following new paragraphs: 
"(2) Subject to paragraph (3), a clinical investigation of a new 
drug may begin 30 days after the Secretary has received from 
the manufacturer or sponsor of the investigation a submission 
containing such information about the drug and the clinical inves-
tigation, including— 
"(A) information on design of the investigation and ade-
quate reports of basic information, certified by the applicant 
to be accurate reports, necessary to assess the safety of the 
drug for use in clinical investigation; and 
"(B) adequate information on the chemistry and manufac-
turing of the drug, controls available for the drug, and primary 
data tabulations from animal or human studies. 
"(3)(A) At any time, the Secretary may prohibit the sponsor 
of an investigation from conducting the investigation (referred to 
in this paragraph as a 'clinical hold') if the Secretary makes a 
determination described in subparagraph (B). The Secretary shall 
specify the basis for the clinical hold, including the specific informa-
tion available to the Secretary which served as the basis for such 
clinical hold, and confirm such determination in writing. 
I l l STAT. 2316 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a chnical hold is 
that— 
"(i) the drug involved represents an unreasonable risk to 
the safety of the persons who are the subjects of the clinical 
investigation, taking into account the qualifications of the clini-
cal investigators, information about the drug, the design of 
the clinical investigation, the condition for which the drug 
is to be investigated, and the health status of the subjects 
involved; or 
"(ii) the clinical hold should be issued for such other reasons 
as the Secretary may by regulation establish (including reasons 
established by regulation before the date of the enactment 
of the Food and Drug Administration Modernization Act of 
1997). 
"(C) Any written request to the Secretary fi-om the sponsor 
of an investigation that a clinical hold be removed shall receive 
a decision, in writing and specifying the reasons therefor, within 
30 days after receipt of such request. Any such request shall include 
sufficient information to support the removal of such clinical hold. 
"(4) Regulations under paragraph (1) shall provide that such 
exemption shall be conditioned upon the manufacturer, or the spon-
sor of the investigation, requiring that experts using such drugs 
for investigational purposes certify to such manufacturer or sponsor 
that they will inform any human beings to whom such drugs, 
or any controls used in connection therewith, are being adminis-
tered, or their representatives, that such drugs are being used 
for investigational purposes and will obtain the consent of such 
human beings or their representatives, except where it is not fea-
sible or it is contrary to the best interests of such human beings. 
Nothing in this subsection shall be construed to require any clinical 
investigator to submit directly to the Secretary reports on the 
investigational use of drugs.". 
21 use 355 note. 
SEC. 118. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS. 
Within 12 months after the date of enactment of this Act, 
the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall issue guidsmce that 
describes when abbreviated study reports may be submitted, in 
lieu of full reports, with a new drug application under section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) and with a biologies license application under section 351 
of the Pubhc Health Service Act (42 U.S.C. 262) for certain types 
of studies. Such guidance shall describe the kinds of studies for 
which abbreviated reports are appropriate and the appropriate 
abbreviated report formats. 
SEC. 119. CONTENT AND REVIEW OF APPLICATIONS. 
(a) SECTION 505(b).—Section 505(b) (21 U.S.C. 355(b)) is amend-
ed by adding at the end the following: 
"(4)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1) or under 
section 351 of the Public Health Service Act, which shall relate 
to promptness in conducting the review, technical excellence, lack 
of bias and conflict of interest, and knowledge of regulatory and 
scientific standards, and which shall apply equally to all individuals 
who review such applications. 
iC«"*j-, 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2317 
"(B) The Secretary shall meet with a sponsor of an investigation 
or an applicant for approval for a drug under this subsection or 
section 351 of the Public Health Service Act if the sponsor or 
applicant makes a reasonable written request for a meeting for 
the purpose of reaching agreement on the design and size of clinical 
trisQs intended to form the primary basis of an effectiveness claim. 
The sponsor or applicant shall provide information necessary for 
discussion and agreement on the design and size of the clinical 
trials. Minutes of any such meeting shall be prepared by the Sec-
retary and made available to the sponsor or applicant upon request. 
"(C) Any agreement regarding the parameters of the design 
and size of clinical trials of a new drug under this paragraph 
that is reached between the Secretary and a sponsor or applicant 
shall be reduced to writing and made part of the administrative 
record by the Secretary. Such agreement shall not be changed 
after the testing begins, except— 
"(i) with the written agreement of the sponsor or applicant; 
or 
"(ii) pursuant to a decision, made in accordance with 
subparagraph (D) by the director of the reviewing division, 
that a substantial scientific issue essential to determining the 
safety or effectiveness of the drug has been identified after 
the testing has begun. 
"(D) A decision under subparagraph (C)(ii) by the director shall 
be in writing and the Secretary shall provide to the sponsor or 
applicant an opportunity for a meeting at which the director and 
the sponsor or applicant will be present and at which the director 
will document the scientific issue involved. 
"(E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance division personnel unless such field or 
compliance division personnel demonstrate to the reviewing division 
why such decision should be modified. 
"(F) No action by the reviewing division may be delayed because 
of the unavailability of information from or action by field personnel 
unless the reviewing division determines that a delay is necessary 
to assure the marketing of a safe and effective drug. 
"(G) For purposes of this paragraph, the reviewing division 
is the division responsible for the review of an application for 
approval of a drug imder this subsection or section 351 of the 
Public Health Service Act (including all scientific and medical mat-
ters, chemistry, manufacturing, and controls).". 
(b) SECTION 505(j).— 
(1) AMENDMENT.—Section 505(j) (21 U.S.C 355(j)) is amend-
ed— 
(A) by redesignating paragraphs (3) through (8) as 
paragraphs (4) through (9), respectively; and 
(B) by adding after paragraph (2) the following: 
"(3)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1), which shall 
relate to promptness in conducting the review, technical excellence, 
lack of bias and conflict of interest, and knowledge of regulatory 
and scientific standards, £ind which shall apply equally to all 
individuals who review such applications. 
"(B) The Secretary shall meet with a sponsor of an investigation 
or an applicant for approval for a drug under this subsection if 
the sponsor or applicant makes a reasonable written request for 
I l l STAT. 2318 
PUBLIC LAW 105-115—NOV. 21, 1997 
a meeting for the purpose of reaching agreement on the design 
and size of bioavailability and bioequivalence studies needed for 
approval of such application. The sponsor or applicant shall provide 
information necessary for discussion and agreement on the design 
and size of such studies. Minutes of any such meeting shall be 
prepared by the Secretary and made available to the sponsor or 
applicant. 
"(C) Any agreement regarding the parameters of design and 
size of bioavailability and bioequivalence studies of a drug under 
this paragraph that is reached between the Secretary and a sponsor 
or applicant shall be reduced to writing and made part of the 
administrative record by the Secretary. Such agreement shall not 
be chsinged after the testing begins, except— 
"(i) with the written agreement of the sponsor or applicant; 
or 
"(ii) pursuant to a decision, made in accordance with 
subparagraph (D) by the director of the reviewing division, 
that a substantial scientific issue essential to determining the 
safety or effectiveness of the drug has been identified after 
the testing has begun. 
"(D) A decision under subparagraph (C)(ii) by the director shall 
be in writing and the Secretary shall provide to the sponsor or 
applicant an opportunity for a meeting at which the director and 
the gponsor or applicant will be present and at which the director 
will document the scientific issue involved. 
"(E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance office personnel unless such field or compli-
ance office personnel demonstrate to the reviewing division why 
such decision should be modified. 
"(F) No action by the reviewing division may be delayed because 
of the unavailability of information from or action by field personnel 
unless the reviewing division determines that a delay is necessary 
to assure the marketing of a safe £ind effective drug. 
"(G) For purposes of this paragraph, the reviewing division 
is the division responsible for the review of an application for 
approval of a drug under this subsection (including scientific mat-
ters, chemistry, manufacturing, and controls).". 
(2) CONFORMING AMENDMENTS.—Section 505(j) (21 U.S.C. 
355(j)), as amended by paragraph (1), is further amended— 
(A) in paragraph (2)(A)(i), by striking "(6)" and insert-
ing "(7)"; 
(B) in paragraph (4) (as redesignated in paragraph 
(D), by striking "(4)" and inserting "(5)"; 
(C) in paragraph (4)(I) (as redesignated in paragraph 
(D), by striking "(5)" and inserting "(6)"; and 
(D) in paragraph (7)(C) (as redesignated in paragraph 
(1)), by striking "(5)" each place it occurs and inserting 
"(6)". 
SEC. 120. SCIENTIFIC ADVISORY PANELS. 
Section 505 (21 U.S.C. 355) is amended by adding at the end 
the following: 
"(n)(l) For the purpose of providing expert scientific advice 
and recommendations to the Secretary regarding a clinical inves-
tigation of a drug or the approval for marketing of a drug under 
section 505 or section 351 of the Public Health Service Act, the 
J . - . ^ l -
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2319 
Secretary shall establish panels of experts or use panels of experts 
established before the date of enactment of the Food and Drug 
Administration Modernization Act of 1997, or both. 
"(2) The Secretary may delegate the appointment and oversight 
authority granted under section 904 to a director of a center or 
successor entity within the Food and Drug Administration. 
"(3) The Secretary shall make appointments to each panel 
established under paragraph (1) so that each panel shall consist 
of— 
"(A) members who are qualified by training and experience 
to evaluate the safety and effectiveness of the drugs to be 
referred to the panel and who, to the extent feasible, possess 
skill and experience in the development, manufacture, or utili-
zation of such drugs; 
"(B) members with diverse expertise in such fields as clini-
cal and administrative medicine, pharmacy, pharmacology, 
pharmacoeconomics, biological and physical sciences, and other 
related professions; 
"(C) a representative of consumer interests, and a rep-
resentative of interests of the drug manufacturing industry 
not directly affected by the matter to be brought before the 
panel; and 
"(D) two or more members who are specialists or have 
other expertise in the particular disease or condition for which 
the drug under review is proposed to be indicated. 
Scientific, trade, and consumer organizations shall be afforded an 
opportunity to nominate individuals for appointment to the panels. 
No individual who is in the regular full-time employ of the United 
States and engaged in the administration of this Act may be a 
voting member of any panel. The Secretary shall designate one 
of the members of each panel to serve as chairman thereof. 
"(4) Each member of a panel shall publicly disclose all conflicts 
of interest that member may have with the work to be undertaken 
by the panel. No member of a panel may vote on any matter 
where the member or the immediate family of such member could 
gain financially from the advice given to the Secretary. The Sec-
retary may grant a waiver of any conflict of interest requirement 
upon public disclosure of such conflict of interest if such waiver 
is necessary to sifford the panel essential expertise, except that 
the Secretary may not grant a waiver for a member of a panel 
when the member's own scientific work is involved. 
"(5) The Secretary shall, as appropriate, provide education and 
training to each new panel member before such member participates 
in a panel's activities, including education regarding requirements 
under this Act and related regulations of the Secretary, and the 
administrative processes and procedures related to panel meetings. 
"(6) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a peinel 
or otherwise engaged in its business, shall be entitled to receive 
compensation for each day so engaged, including traveltime, at 
rates to be fixed by the Secretary, but not to exceed the daily 
equivalent of the rate in effect for positions classified above grade 
GS-15 of the General Schedule. While serving away from their 
homes or regular places of business, panel members may be allowed 
travel expenses (including per diem in lieu of subsistence) as author-
ized by section 5703 of title 5, United States Code, for persons 
in the Government service employed intermittently. 
I l l STAT. 2320 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(7) The Secretary shall ensure that scientific advisory panels 
meet regularly and at appropriate intervals so that any matter 
to be reviewed by such a panel can be presented to the panel 
not more than 60 days after the matter is ready for such review. 
Meetings of the panel may be held using electronic communication 
to convene the meetings. 
"(8) Within 90 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and 
Drug Administration official responsible for the matter shall review 
the conclusions and recommendations of the panel, and notify the 
affected persons of the final decision on the matter, or of the 
reasons that no such decision has been reached. Each such final 
decision shall be documented including the rationale for the deci-
sion.". 
SEC. 121. POSITRON EMISSION TOMOGRAPHY. 
(a) REGULATION OF COMPOUNDED POSITRON EMISSION TOMOG-
RAPHY DRUGS.—Section 201 (21 U.S.C. 321) is amended by adding 
at the end the following: 
"(ii) The term 'compounded positron emission tomography 
drug*— 
"(1) means a drug that— 
"(A) exhibits spontaneous disintegration of unstable 
nuclei by the emission of positrons and is used for the 
purpose of providing dual photon positron emission tomo-
graphic diagnostic images; and 
"(B) has been compounded by or on the order of a 
practitioner who is licensed by a State to compound or 
order compounding for a drug described in subparagraph 
(A), and is compounded in accordance with that State's 
law, for a patient or for research, teaching, or quality 
control; and 
"(2) includes any nonradioactive reagent, reagent kit, 
ingredient, nuclide generator, accelerator, target material, elec-
tronic synthesizer, or other apparatus or computer program 
to be used in the preparation of such a drug.". 
(b) ADULTERATION.— 
(1) IN GENERAL.—Section 501(a) (21 U.S.C. 351(a)) is 
amended by striking "; or (3)" and inserting the following: 
"; or (C) if it is a compounded positron emission tomography 
drug and the methods used in, or the facilities and controls 
used for, its compounding, processing, packing, or holding do 
not conform to or are not operated or administered in conformity 
with the positron emission tomography compounding standards 
and the official monographs of the United States Pharmacopoeia 
to assure that such drug meets the requirements of this Act 
as to safety £ind has the identity and strength, and meets 
the quality and purity characteristics, that it purports or is 
represented to possess; or (3)". 
21 use 351 note. 
(2) SuNSET.—Section 501(a)(2)(C) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 
4 years after the date of enactment of this Act or 2 years 
after the date on which the Secretary of Health and Human 
Services establishes the requirements described in subsection 
(c)(1)(B), whichever is later. 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2321 
(c) REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND 21 use 355 note. 
CURRENT GOOD MANUFACTURING PRACTICES FOR POSITRON EMIS-
SION TOMOGRAPHY.— 
(1) PROCEDURES AND REQUIREMENTS.— 
(A) IN GENERAL.—In order to take account of the special 
characteristics of positron emission tomography drugs and 
the special techniques and processes required to produce 
these drugs, not later than 2 years after the date of enact-
ment of this Act, the Secretary of Health and Human 
Services shall establish— 
(i) appropriate procedures for the approval of 
positron emission tomography drugs pursuant to sec-
tion 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355); and 
(ii) appropriate current good manufacturing prac-
tice requirements for such drugs. 
(B) CONSIDERATIONS AND CONSULTATION.—In establish-
ing the procedures and requirements required by subpara-
graph (A), the Secretary of Health and Human Services 
shall take due account of any relevant differences between 
not-for-profit institutions that compound the drugs for their 
patients £ind commercial manufacturers of the drugs. Prior 
to establishing the procedures and requirements, the Sec-
retary of Health and Human Services shall consult with 
patient advocacy groups, professional associations, manu-
facturers, and physicians and scientists licensed to make 
or use positron emission tomography drugs. 
(2) SUBMISSION OF NEW DRUG APPLICATIONS AND ABBRE-
VIATED NEW DRUG APPLICATIONS.— 
(A) IN GENERAL.—Except as provided in subparagraph 
(B), the Secretary of Health and Human Services shall 
not require the submission of new drug applications or 
abbreviated new drug applications under subsection (b) 
or (j) of section 505 (21 U.S.C. 355), for compoimded 
positron emission tomography drugs that are not adulter-
ated drugs described in section 501(a)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as 
amended by subsection (b)), for a period of 4 years after 
the date of enactment of this Act, or for 2 years after 
the date on which the Secretary establishes procedures 
and requirements under paragraph (1), whichever is longer. 
(B) EXCEPTION.—Nothing in this Act shall prohibit the 
voluntary submission of such applications or the review 
of such applications by the Secretary of Health and Human 
Services. Nothing in this Act shall constitute an exemption 
for a positron emission tomography drug from the require-
ments of regulations issued under section 505(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). 
(d) REVOCATION OF CERTAIN INCONSISTENT DOCUMENTS.— Federal Register, 
Within 30 days after the date of enactment of this Act, the Secretary publication. 
of Health and Humsui Services shall publish in the Federal Register 
a notice terminating the application of the following notices and 
rule: 
(1) A notice entitled "Regulation of Positron Emission 
Tomography Radiopharmaceutical Drug Products; Guidance; 
Public Workshop", published in the Federal Register on Feb-
ruary 27, 1995, 60 Fed. Reg. 10594. 
I l l STAT. 2322 
PUBLIC LAW 105-115—NOV. 21, 1997 
(2) A notice entitled "Draft Guideline on the Manufacture 
of Positron Emission Tomography Radiopharmaceutical Drug 
Products; Availability", published in the Federal Register on 
February 27, 1995, 60 Fed. Reg. 10593. 
(3) A final rule entitled "Current Good Manufacturing Prac-
tice for Finished Pharmaceuticals; Positron Emission Tomog-
raphy, published in the Federal Register on April 22, 1997, 
62 Fed. Reg. 19493 (codified at part 211 of title 21, Code 
of Federal Regulations). 
21 use 355 note. 
(e) DEFINITION.—^As used in this section, the term "compounded 
positron emission tomography drug" has the meaning given the 
term in section 201 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321). 
21 u s e 355 note. 
SEC. 122. REQUIREMENTS FOR RADIOPHARMACEUTICALS. 
(a) REQUIREMENTS.— 
(1) REGULATIONS.— 
(A) PROPOSED REGULATIONS.—Not later than 180 days 
after the date of enactment of this Act, the Secretary of 
Health and Human Services, after consultation with 
patient advocacy groups, associations, physicians licensed 
to use radiopharmaceuticals, and the regulated industry, 
shall issue proposed regulations governing the approval 
of radiopharmaceuticals. The regulations shall provide that 
the determination of the safety and effectiveness of such 
a radiopharmaceutical under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 
351 of the PubUc Health Service Act (42 U.S.C. 262) shall 
include 
consideration 
of 
the 
proposed 
use 
of 
the 
radiopharmaceutical in the practice of medicine, the 
pharmacological 
and 
toxicological 
activity 
of 
the 
radiopharmaceutical 
(including any carrier or ligand 
component of the radiopharmaceutical), and the estimated 
absorbed radiation dose of the radiopharmaceutical. 
(B) FINAL REGULATIONS.—Not later than 18 months 
after the date of enactment of this Act, the Secretary shall 
promulgate final regulations governing the approval of the 
radiopharmaceuticals. 
(2) SPECIAL RULE.—In the case of a radiopharmaceutical, 
the indications for which such radiopharmaceutical is approved 
for marketing may, in appropriate cases, refer to manifestations 
of disease (such as biochemical, physiological, anatomic, or 
pathological processes) common to, or present in, one or more 
disease states. 
(b) DEFINITION.—In this section, the term 
"radiopharma-
ceutical" means— 
(1) an article— 
(A) that is intended for use in the diagnosis or monitor-
ing of a disease or a manifestation of a disease in humans; 
and 
(B) that exhibits spontaneous disintegration of unstable 
nuclei with the emission of nuclear particles or photons; 
or 
(2) any nonradioactive reagent kit or nuclide generator 
that is intended to be used in the preparation of any such 
article. 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2323 
SEC. 123. MODERNIZATION OF REGULATION. 
(a) LICENSES.— 
(1) IN GENERAL.—Section 351(a) of the Public Health Serv-
ice Act (42 U.S.C. 262(a)) is amended to read as follows: 
"(a)(1) No person shall introduce or deliver for introduction 
into interstate commerce any biological product unless— 
"(A) a biologies license is in effect for the biological product; 
and 
"(B) each package of the biological product is plainly 
marked with— 
"(i) the proper name of the biological product contained 
in the package; 
"(ii) the name, address, and applicable license number 
of the manufacturer of the biological product; and 
"(iii) the expiration date of the biological product. 
"(2)(A) The Secretary shall establish, by regulation, require-
ments for the approval, suspension, and revocation of biologies 
licenses. 
"(B) The Secretary shall approve a biologies license applica-
tion— 
"(i) on the basis of a demonstration that— 
"(I) the biological product that is the subject of the 
application is safe, pure, and potent; and 
"(II) the facility in which the biological product is 
manufactured, processed, packed, or held meets standards 
designed to assure that the biological product continues 
to be safe, pure, and potent; and 
"(ii) if the applicant (or other appropriate person) consents 
to the inspection of the facility that is the subject of the applica-
tion, in accordance with subsection (c). 
"(3) The Secretary shall prescribe requirements under which 
a biological product undergoing investigation shall be exempt from 
the requirements of paragraph (1).". 
(2) ELIMINATION OF EXISTING LICENSE REQUIREMENT.—Sec-
tion 351(d) of the Pubhc Health Service Act (42 U.S.C. 262(d)) 
is amended— 
(A) by striking "(d)(1)" and all that follows through 
"of this section."; 
(B) in paragraph (2)— 
(i) by striking "(2)(A) Upon" and inserting "(d)(1) 
Upon"and 
(ii) by redesignating subparagraph (B) as para-
graph (2); and 
(C) in paragraph (2) (as so redesignated by subpara-
graph (B)(ii))— 
(i) by striking "subparagraph (A)" and inserting 
"paragraph (1)"; and 
(ii) by striking "this subparagraph" each place it 
appears and inserting "this paragraph". 
(b) LABELING.—Section 351(b) of the Public Health Service Act 
(42 U.S.C. 262(b)) is amended to read as follows: 
"(b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark 
on the package or container of the biological product so as to 
falsify the label or mark.". 
I l l STAT. 2324 
PUBLIC LAW 105-115—NOV. 21, 1997 
(c) INSPECTION.—Section 351(c) of the Public Health Service 
Act (42 U.S.C. 262(c)) is amended by striking "virus, serum," and 
all that follows and inserting "biological product.". 
(d) DEFINITION; APPLICATION.—Section 351 of the Pubhc Health 
Service Act (42 U.S.C. 262) is amended by adding at the end 
the following: 
"(i) In this section, the term 'biological product' means a virus, 
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component 
or derivative, allergenic product, or analogous product, or arsphen-
amine or derivative of arsphenamine (or any other trivalent organic 
arsenic compound), applicable to the prevention, treatment, or cure 
of a disease or condition of human beings.". 
(e) CONFORMING AMENDMENT.—Section 503(g)(4) (21 U.S.C. 
353(g)(4)) is amended— 
(1) in subparagraph (A)— 
(A) by striking "section 351(a)" and inserting "section 
351(i)"; and 
(B) by striking "262(a)" and inserting "262(i)"; and 
(2) in subparagraph (B)(iii), by striking "product or 
establishment license under subsection (a) or (d)" and inserting 
"biologies license application under subsection (a)". 
21 use 355 note. 
(f) SPECIAL RULE.—The Secretary of Health and Human Serv-
ices shall take measures to minimize differences in the review 
and approval of products required to have approved biologies license 
applications under section 351 of the Public Health Service Act 
(42 U.S.C. 262) and products required to have approved new drug 
applications under section 505(b)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)(1)). 
(g) APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC 
ACT.—Section 351 of the Pubhc Health Service Act (42 U.S.C. 
262), as amended by subsection (d), is further amended by adding 
at the end the following: 
"(j) The Federal Food, Drug, and Cosmetic Act applies to a 
biological product subject to regulation under this section, except 
that a product for which a license has been approved under sub-
section (a) shall not be required to have an approved application 
under section 505 of such Act.". 
(h) EXAMINATIONS AND PROCEDURES.—Paragraph (3) of section 
353(d) of the Pubhc Health Service Act (42 U.S.C. 263a(d)) is 
amended to read as follows: 
"(3) EXAMINATIONS AND PROCEDURES.—The examinations 
and procedures identified in paragraph (2) are laboratory 
examinations and procedures that have been approved by the 
Food and Drug Administration for home use or that, as deter-
mined by the Secretary, are simple laboratory examinations 
and procedures that have an insignificant risk of an erroneous 
result, including those that— 
"(A) employ methodologies that are so simple and 
accurate as to render the likelihood of erroneous results 
by the user negligible, or 
"(B) the Secretary has determined pose no unreason-
able risk of harm to the patient if performed incorrectly.". 
SEC. 124. PILOT AND SMALL SCALE MANUFACTURE. 
(a) HUMAN DRUGS.—Section 505(c) (21 U.S.C. 355(c)) is amend-
ed by adding at the end the following: 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2325 
"(4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
^ 
drug and to obtain approval for the drug prior to manufacture 
of the drug in a larger facility, unless the Secretary makes a 
determination that a full scale production facility is necessary to 
ensure the safety or effectiveness of the drug.". 
(b) ANIMAL DRUGS.—Section 512(c) (21 U.S.C. 360b(c)) is 
amended by adding at the end the following: 
"(4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval for the drug prior to manufacture 
of the drug in a larger facility, unless the Secretary makes a 
determination that a full scale production facility is necessary to 
ensure the safety or effectiveness of the drug.". 
SEC. 125. INSULIN AND ANTIBIOTICS. 
(a) CERTIFICATION OF DRUGS CONTAINING INSULIN.— 
(1) AMENDMENT.—Section 506 (21 U.S.C. 356), as in effect 
before the date of the enactment of this Act, is repealed. 
(2) CONFORMING AMENDMENTS.— 
(A) Section 301(j) (21 U.S.C. 331(j)) is amended by 
striking "506, 507,". 
(B) Subsection (k) of section 502 (21 U.S.C. 352) is 
I*6T)63.1GQ 
(C) Sections 301(i)(l), 510(j)(l)(A), and 510(j)(l)(D) (21 
U.S.C. 331(i)(l), 360(j)(l)(A), 360(j)(l)(D)) are each amended 
by striking ", 506, 507,", 
(D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended 
by inserting after "503(b)" the following: "cr composed 
wholly or partly of insulin". 
(E) Section 8126(h)(2) of title 38, United States Code, 
is amended by inserting "or" at the end of subparagraph 
(B), by striking "; or" at the end of subparagraph (C) 
and inserting a period, and by striking subparagraph (D). 
(b) CERTIFICATION OF ANTIBIOTICS.— 
(1) AMENDMENT.—Section 507 (21 U.S.C. 357) is repealed. 
(2) CONFORMING AMENDMENTS.— 
(A) Section 201(aa) (21 U.S.C. 321(aa)) is amended 
by striking out "or 507", section 201(dd) (21 U.S.C. 321(dd)) 
is amended by striking "507,", and section 201(fD(3)(A) 
(21 U.S.C. 321(fD(3)(A)) is amended by striking ", certified 
as an antibiotic under section 507,". 
(B) Section 301(e) (21 U.S.C. 331(e)) is amended by 
striking "507(d) or (g),". 
(C) Section 306(d)(4)(B)(ii) (21 U.S.C. 335a(d)(4)(B)(ii)) 
is amended by striking "or 507". 
(D) Section 502 (21 U.S.C. 352) is amended by striking 
subsection (1). 
(E) Section 520(1) (21 U.S.C. 360j(l)) is amended by 
striking paragraph (4) and by striking "or Antibiotic Drugs" 
in the subsection heading. 
(F) Section 525(a) (21 U.S.C. 360aa(a)) is amended 
by inserting "or" at the end of paragraph (1), by striking 
paragraph (2), and by redesignating paragraph (3) as para-
graph (2). 
I l l STAT. 2326 
PUBLIC LAW 105-115—NOV. 21, 1997 
(G) Section 525(a) (21 U.S.C. 360aa(a)) is amended 
by striking ", certification of such drug for such disease 
or condition under section 507,", 
(H) Section 526(a)(1) (21 U.S.C. 360bb) is amended 
by striking "the submission of an application for certifi-
cation of the drug under section 507,", by inserting "or" 
at the end of subparagraph (A), by striking subparagraph 
(B), and by redesignating subparagraph (C) as subpara-
graph (B), 
(I) Section 526(b) (21 U.S.C. 360bb(b)) is amended— 
(i) in paragraph (1), by striking ", a certificate 
was issued for the drug under section 507,"; and 
(ii) in paragraph (2) by striking ", a certificate 
has not been issued for the drug under section 507," 
and by striking ", approval of an application for certifi-
cation under section 507,". 
(J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by 
inserting "or" at the end of paragraph (1), by striking 
paragraph (2), by redesignating paragraph (3) as paragraph 
(2), and by striking ", issue another certification under 
section 507,". 
(K) Section 527(b) (21 U.S.C. 360cc(b)) is amended 
by striking ", if a certification is issued under section 
507 for such a drug,", ", of the issuance of the certification 
under section 507,", ", issue another certification under 
section 507,", ", of such certification,", ", of the certifi-
cation,", and ", issuance of other certifications,". 
(L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended 
by striking ", section 507 (d) or (g),". 
(M) Section 735(1) (21 U.S.C. 379g(l)(C)) is amended 
by inserting "or" at the end of subparagraph (B), by striking 
subparagraph (C), and by redesignating subparagraph (D) 
as subparagraph (C). 
(N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) 
of the Orphan 
Drug Act (21 U.S.C. 360ee(b)(l)(A), 
360ee(b)(l)(B)) are each amended by striking "or 507". 
(O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue 
26 use 45C. 
Code of 1986 is amended by striking "or 507". 
(P) Section 156(f)(4)(B) of title 35, United States Code, 
is amended by striking "507," each place it occurs, 
(c) EXPORTATION.—Section 802 (21 U.S.C. 382) is amended by 
adding at the end the following: 
"(i) Insulin and antibiotic drugs may be exported without regard 
to the requirements in this section if the insulin and antibiotic 
drugs meet the requirements of section 801(e)(1).". 
21 u s e 355 note. 
(d) TRANSITION.— 
(1) IN GENERAL.—^An application that was approved by 
the Secretary of Health and Human Services before the date 
of the enactment of this Act for the marketing of an antibiotic 
drug under section 507 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 357), as in effect on the day before the date 
of the enactment of this Act, shall, on and after such date 
of enactment, be considered to be an application that was 
submitted and filed under section 505(b) of such Act (21 U.S.C. 
355(b)) £uid approved for safety and effectiveness under section 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2327 
505(c) of such Act (21 U.S.C. 355(c)), except that if such applica-
tion for marketing was in the form of an abbreviated apphca-
tion, the appHcation shall be considered to have been filed 
and approved under section 505(j) of such Act (21 U.S.C. 355(j)). 
(2) EXCEPTION.—The following subsections of section 505 
(21 U.S.C. 355) shall not apply to any application for marketing 
in which the drug that is the subject of the application contains 
an antibiotic drug and the antibiotic drug was the subject 
of any application for marketing received by the Secretary 
of Health and Human Services under section 507 of such Act 
(21 U.S.C. 357) before the date of the enactment of this Act: 
(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii), 
(j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and 
(ii) The third and fourth sentences of subsection (b)(1) 
(regarding the filing and publication of patent information); 
and 
(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) 
if the investigations relied upon by the applicant for 
approval of the application were not conducted by or for 
the applicant and for which the applicant has not obtained 
a right of reference or use from the person by or for 
whom the investigations were conducted. 
(3) PUBLICATION.—For purposes of this section, the Sec-
retary is authorized to make available to the public the estab-
lished name of each antibiotic drug that was the subject of 
any application for marketing received by the Secretary for 
Health and Human Services under section 507 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 357) before the date 
of enactment of this Act. 
(e) DEFINITION.—Section 201 (21 U.S.C. 321), as amended by 
section 121(a)(1), is further amended by adding at the end the 
following: 
"(jj) The term 'antibiotic drug* means any drug (except drugs 
for use in animals other than humans) composed wholly or partly 
of any kind of penicillin, streptomycin, chlortetracycline, chlor-
amphenicol, bacitracin, or any other drug intended for human use 
containing any quantity of any chemical substance which is pro-
duced by a micro-organism and which has the capacity to inhibit 
or destroy micro-organisms in dilute solution (inclu(Ung a chemically 
synthesized equivalent of any such substance) or any derivative 
thereof.". 
SEC. 126. ELIMINATION OF CERTAIN LABELING REQUIREMENTS. 
(a) 
PRESCRIPTION 
DRUGS.—Section 
503(b)(4) 
(21 
U.S.C. 
353(b)(4)) is amended to read as follows: 
"(4)(A) A drug that is subject to paragraph (1) shall be deemed 
to be misbranded if at any time prior to dispensing the label 
of the drug fails to bear, at a minimum, the sjnnbol *Rx only'. 
"(B) A drug to which paragraph (1) does not apply shall be 
deemed to be misbranded if at any time prior to dispensing the 
label of the drug bears the symbol described in subparagraph (A).". 
(b) MISBRANDED DRUG.—Section 502(d) (21 U.S.C. 352(d)) is 
repealed. 
(c) CONFORMING AMENDMENTS.— 
(1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended— 
(A) by striking subparagraph (A); and 
I l l STAT. 2328 
PUBLIC LAW 105-115—NOV. 21, 1997 
(B) by redesignating subparagraphs (B) and (C) as 
subparagraphs (A) and (B), respectively. 
(2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by 
striking "section 502(d) and". 
(3) Section 102(9)(A) of the Controlled Substances Act (21 
U.S.C. 802(9)(A)) is amended— 
(A) in clause (i), by striking "(i)"; and 
(B) by striking "(ii)" and all that follows. 
SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHAR-
• MACY COMPOUNDING. 
(a) AMENDMENT.—Chapter V is amended by inserting after 
section 503 (21 U.S.C. 353) the following: 
21 u s e 353a. 
"SEC. 503A. PHARMACY COMPOUNDING. 
"(a) IN GENERAL.—Sections 501(a)(2)(B), 502(f)(1), and 505 shall 
not apply to a drug product if the drug product is compounded 
for an identified individual patient based on the unsolicited receipt 
of a valid prescription order or a notation, approved by the prescrib-
ing practitioner, on the prescription order that a compounded prod-
uct is necessary for the identified patient, if the drug product 
meets the requirements of this section, and if the compounding— 
" ( l ) i s b y -
"(A) a licensed pharmacist in a State licensed pharmacy 
or a Federal facility, or 
"(B) a licensed physician, 
on the prescription order for such individual patient made 
by a licensed physician or other licensed practitioner authorized 
by State law to prescribe drugs; or 
"(2)(A) is by a licensed pharmacist or licensed physician 
in limited quantities before the receipt of a valid prescription 
order for such individual patient; and 
"(B) is based on a history of the licensed pharmacist or 
licensed physician receiving valid prescription orders for the 
compounding of the drug product, which orders have been 
generated solely within an established relationship between— 
"(i) the licensed pharmacist or licensed physician; and 
"(ii)(I) such individual patient for whom the prescrip-
tion order will be provided; or 
"(II) the physician or other licensed practitioner who 
will write such prescription order. 
"(b) COMPOUNDED DRUG.— 
"(1) 
LICENSED PHARMACIST AND LICENSED PHYSICIAN.—A 
drug product may be compounded under subsection (a) if the 
licensed pharmacist or licensed physician— 
"(A) compounds the drug product using bulk drug sub-
stances, as defined in regulations of the Secretary published 
at section 207.3(a)(4) of title 21 of the Code of Federal 
Regulations— 
"(i) that— 
"(I) comply with the standards of an applicable 
United States Pharmacopoeia or National For-
mulary monograph, if a monograph exists, and 
the United States Pharmacopoeia chapter on phar-
macy compounding; 
"(II) if such a monograph does not exist, are 
drug substances that are components of drugs 
approved by the Secretary; or 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2329 
"(III) if such a monograph does not exist and 
the drug substance is not a component of a drug 
approved by the Secretary, that appear on a list 
developed by the Secretary through regulations 
issued by the Secretary under subsection (d); 
"(ii) that are manufactured by an establishment 
that is registered under section 510 (including a foreign 
establishment that is registered under section 510(i)); 
and 
"(iii) that are accompanied by valid certificates 
of analysis for each bulk drug substance; 
"(B) compounds the drug product using ingredients 
(other than bulk drug substances) that comply with the 
standards of an applicable United States Pharmacopoeia 
or National Formulary monograph, if a monograph exists, 
and the United States Pharmacopoeia chapter on pharmacy 
compounding; 
"(C) does not compound a drug product that appears 
on a list published by the Secretary in the Federal Register 
of drug products that have been withdrawn or removed 
from the market because such drug products or components 
of such drug products have been found to be unsafe or 
not effective; and 
"(D) does not compound regularly or in inordinate 
amounts (as defined by the Secretary) any drug products 
that are essentially copies of a commercially available drug 
product. 
"(2) DEFINITION.—For purposes of paragraph (1)(D), the 
term 'essentially a copy of a commercially available drug prod-
uct' does not include a drug product in which there is a change, 
made for an identified individual patient, which produces for 
that patient a significant difference, as determined by the 
prescribing practitioner, between the compounded drug and 
the comparable commercially available drug product. 
"(3) DRUG PRODUCT.—A drug product may be compounded 
under subsection (a) only if— 
"(A) such drug product is not a drug product identified 
by the Secretary by regulation as a drug product that 
presents demonstrable difficulties for compounding that 
reasonably demonstrate an adverse effect on the safety 
or effectiveness of that drug product; and 
"(B) such drug product is compounded in a State— 
"(i) that has entered into a memorandum of under-
standing with the Secretary which addresses the dis-
tribution of inordinate amounts of compounded drug 
products interstate and provides for appropriate inves-
tigation by a State agency of complaints relating to 
compounded drug products distributed outside such 
State; or 
"(ii) that has not entered into the memorandum 
of understanding described in clause (i) and the 
licensed pharmacist, licensed pharmacy, or licensed 
physician distributes (or causes to be distributed) 
compounded drug products out of the State in which 
they are compounded in quantities that do not exceed 
5 percent of the total prescription orders dispensed 
or distributed by such pharmacy or physician. 
I l l STAT. 2330 
PUBLIC LAW 105-115—NOV. 21, 1997 
The Secretary shall, in consultation with the National Associa-
tion of Boards of Pharmacy, develop a standard memorandum 
of understanding for use by the States in complying with 
subparagraph (BXi). 
"(c) ADVERTISING AND PROMOTION.—^A drug may be compounded 
under subsection (a) only if the pharmacy, licensed pharmacist, 
or licensed physician does not advertise or promote the compounding 
of any particular drug, class of drug, or type of drug. The pharmacy, 
licensed pharmacist, or licensed physician may advertise and pro-
mote the compounding service provided by the licensed pharmacist 
or licensed physician. 
"(d) REGULATIONS.— 
"(1) IN GENERAL.—The Secretary shall issue regulations 
to implement this section. Before issuing regulations to imple-
ment subsections (b)(l)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Sec-
retary shall convene and consult an advisory committee on 
compounding unless the Secretary determines that the issuance 
of such regulations before consultation is necessary to protect 
the public health. The advisory committee shall include rep-
resentatives from the National Association of Boards of Phar-
macy, the United States Pharmacopoeia, pharmacy, physician, 
and consumer organizations, and other experts selected by the 
Secretary. 
"(2) LIMITING COMPOUNDING.—The Secretary, in consulta-
tion with the United States Pharmacopoeia Convention, Incor-
porated, shall promulgate regulations identifying drug sub-
stances that may be used in compounding under subsection 
(b)(l)(A)(i)(III) for which a monograph does not exist or which 
are not components of drug products approved by the Secretary. 
The Secretary shall include in the regulation the criteria for 
such substances, which shall include historical use, reports 
in peer reviewed medical literature, or other criteria the Sec-
retary may identify. 
"(e) APPLICATION.—This section shall not apply to— 
"(1) compounded positron emission tomography drugs as 
defined in section 201(ii); or 
"(2) radiopharmaceuticals. 
"(f) 
DEFINITION.—^As 
used 
in 
this 
section, 
the 
term 
'compounding' does not include mixing, reconstituting, or other such 
acts that are performed in accordance with directions contained 
in approved labeling provided by the product's manufacturer and 
other manufacturer directions consistent with that labeling.". 
21 use 353a 
(b) EFFECTIVE DATE.—Section 503A of the Federal Food, Drug, 
note. 
and Cosmetic Act, added by subsection (a), shall take effect upon 
the expiration of the 1-year period beginning on the date of the 
enactment of this Act. 
SEC. 128. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PRO-
GRAM. 
Section 2 of PubHc Law 102-222 (105 Stat. 1677) is amended— 
(1) in subsection (a), by striking "a grant" and all that 
follows through "Such grant" and inserting the following: 
"grants for a pilot program for the training of individuals in 
clinical pharmacology at appropriate medical schools. Such 
grants"; and 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2331 
(2) in subsection (b), by striking "to carry out this section" 
and inserting ", and for fiscal years 1998 through 2002 
$3,000,000 for each fiscal year, to carry out this section". 
SEC. 129. REGULATIONS FOR SUNSCREEN PRODUCTS. 
21 USC 393 note. 
Not later than 18 months after the date of enactment of this 
Act, the Secretary of Health and Human Services shall issue regula-
tions for over-the-counter sunscreen products for the prevention 
or treatment of sunburn. 
SEC. 130. REPORTS OF POSTMARKETING APPROVAL STUDIES. 
(a) IN GENERAL.—Chapter V, as amended by section 116, is 
further amended by inserting after section 506A the following: 
"SEC. 506B. REPORTS OF POSTMARKETING STUDIES. 
21 USC 356b. 
"(a) SUBMISSION.— 
"(1) IN GENERAL.—^A sponsor of a drug that has entered 
into 
an 
agreement 
with 
the 
Secretary 
to 
conduct 
a 
postmarketing study of a drug shall submit to the Secretary, 
within 1 year after the approved of such drug and annually 
thereafter until the study is completed or terminated, a report 
of the progress of the study or the reasons for the failure 
of the sponsor to conduct the study. The report shall be submit-
ted in such form as is prescribed by the Secretary in regulations 
issued by the Secretary. 
"(2) AGREEMENTS PRIOR TO EFFECTIVE DATE.—^Any agree-
ment entered into between the Secretary and a sponsor of 
a drug, prior to the date of enactment of the Food and Drug 
Administration Modernization Act of 1997, to conduct a 
postmarketing study of a drug shall be subject to the require-
ments of paragraph (1). An initial report for such an agreement 
shall be submitted within 6 months after the date of the issu-
ance of the regulations under paragraph (1). 
"(b) CONSIDERATION OF INFORMATION AS PUBLIC INFORMA-
TION.—^Any information pertaining to a report described in sub-
section (a) shall be considered to be public information to the 
extent that the information is necessary— 
"(1) to identify the sponsor; and 
"(2) to establish the status of a study described in sub-
section (a) and the reasons, if any, for any failure to carry 
out the study. 
"(c) STATUS OF STUDIES AND REPORTS.—The Secretary shall Federal Register, 
annuEdly develop and publish in the Federal Register a report publication. 
that provides information on the status of the postmarketing 
studies— 
"(1) that sponsors have entered into agreements to conduct; 
and 
"(2) for which reports have been submitted under sub-
section (a)(1).". 
(b) REPORT TO CONGRESSIONAL COMMITTEES.—Not later than 21 use 356b 
October 1, 2001, the Secretary shall prepare and submit to the note. 
Committee on Labor and Human Resources of the Senate and 
the Committee on Commerce of the House of Representatives a 
report containing— 
(1) a summary of the reports submitted under section 506B 
of the Federal Food, Drug, and Cosmetic Act; 
(2) £in evaluation of— 
I l l STAT. 2332 
PUBLIC LAW 105-115—NOV. 21, 1997 
(A) the performance of the sponsors referred to in 
such section in fulfilling the agreements with respect to 
the conduct of postmarketing studies described in such 
section of such Act; and 
(B) the timeliness of the Secretary's review of the 
postmarketing studies; and 
(3) 
any 
legislative 
recommendations 
respecting 
the 
postmarketing studies. 
SEC. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING 
PRODUCT. 
(a) IN GENERAL.—Chapter V, as amended by section 130, is 
further amended by inserting after section 506B the following: 
21 use 356c. 
"SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT. 
"(a) IN GENERAL.—^A manufacturer that is the sole manufac-
turer of a drug— 
"(1) that is— 
"(A) life-supporting; 
"(B) life-sustaining; or 
"(C) intended for use in the prevention of a debilitating 
disease or condition; 
"(2) for which an application has been approved under 
section 505(b) or 505(j); and 
"(3) that is not a product that was originally derived from 
human tissue and was replaced by a recombinant product, 
shall notify the Secretary of a discontinuance of the manufacture 
of the drug at least 6 months prior to the date of the discontinuance. 
"(b) REDUCTION 
IN NOTIFICATION 
PERIOD.—The notification 
period required under subsection (a) for a manufacturer may be 
reduced if the manufacturer certifies to the Secretary that good 
cause exists for the reduction, such as a situation in which— 
"(1) a public health problem may result from continuation 
of the manufacturing for the 6-month period; 
"(2) a biomaterials shortage prevents the continuation of 
the manufacturing for the 6-month period; 
"(3) a liability problem may exist for the manufacturer 
if the manufacturing is continued for the 6-month period; 
"(4) continuation of the manufacturing for the 6-month 
period may cause substantial economic hardship for the manu-
facturer; 
"(5) the manufacturer has filed for bankruptcy under chap-
ter 7 or 11 of title 11, United States Code; or 
"(6) the manufacturer can continue the distribution of the 
drug involved for 6 months. 
"(c) DISTRIBUTION.—To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation of 
the drugs described in subsection (a) to appropriate physician and 
patient organizations.". 
TITLE II—IMPROVING REGULATION OF 
DEVICES 
SEC. 201. INVESTIGATIONAL DEVICE EXEMPTIONS. 
(a) IN GENERAL.—Section 520(g) (21 U.S.C. 360j(g)) is amended 
by adding at the end the following: 
>s>4t^ 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2333 
"(6)(A) Not later than 1 year after the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997, 
the Secretary shall by regulation establish, with respect to a device 
for which an exemption under this subsection is in effect, procedures 
and conditions that, without requiring an additional approval of 
an application for an exemption or the approval of a supplement 
to such an application, permit— 
"(i) developmental changes in the device (including manu-
facturing changes) that do not constitute a significant change 
in design or in basic principles of operation and that are made 
in response to information gathered during the course of an 
investigation; and 
"(ii) changes or modifications to clinical protocols that do 
not affect— 
"(I) the validity of data or information resulting from 
the completion of an approved protocol, or the relationship 
of likely patient risk to benefit relied upon to approve 
a protocol; 
"(II) the scientific soundness of an investigational plan 
- submitted under paragraph (3)(A); or 
"(III) the rights, safety, or welfare of the human sub-
jects involved in the investigation. 
"(B) Regulations under subparagraph (A) shall provide that 
a change or modification described in such subparagraph may be 
made if— 
"(i) the sponsor of the investigation determines, on the 
basis of credible information (as defined by the Secretary) that 
the applicable conditions under subparagraph (A) are met; and 
"(ii) the sponsor submits to the Secretary, not later than 
5 days after making the change or modification, a notice of 
the change or modification. 
"(7)(A) In the case of a person intending to investigate the 
safety or effectiveness of a class III device or any implantable 
device, the Secretary shall ensure that the person has an oppor-
tunity, prior to submitting an application to the Secretary or to 
an institutional review committee, to submit to the Secretary, for 
review, an investigational plan (including a clinical protocol). If 
the applicant submits a written request for a meeting with the 
Secretary regarding such review, the Secretary shall, not later 
than 30 days after receiving the request, meet with the applicant 
for the purpose of reaching agreement regarding the investigational 
plan (including a clinical protocol). The written request shall include 
a detailed description of the device, a detailed description of the 
proposed conditions of use of the device, a proposed plan (including 
a clinical protocol) for determining whether there is a reasonable 
assurance of effectiveness, and, if available, information regarding 
the expected performance from the device. 
"(B) Any agreement regarding the parameters of an investiga-
tional plan (including a clinical protocol) that is reached between 
the Secretary and a sponsor or applicant shall be reduced to writing 
and made part of the administrative record by the Secretary. Any 
such agreement shall not be changed, except— 
"(i) with the written agreement of the sponsor or applicant; 
or 
"(ii) pursuant to a decision, made in accordance with 
subparagraph (C) by the director of the office in which the 
device involved is reviewed, that a substantial scientific issue 
I l l STAT. 2334 
PUBLIC LAW 105-115—NOV. 21, 1997 
essential to determining the safety or effectiveness of the device 
involved has been identified, 
"(C) A decision under subparagraph (B)(ii) by the director shall 
be in writing, and may be made only after the Secretary has 
provided to the sponsor or applicant an opportunity for a meeting 
at which the director and the sponsor or applicant are present 
and at which the director documents the scientific issue involved.", 
(b) ACTION ON APPLICATION.—Section 515(d)(1)(B) (21 U.S.C. 
360e(d)(l)(B)) is amended by adding at the end the following: 
"(iii) The Secretary shall accept and review statistically valid 
and reliable data and any other information from investigations 
conducted under the authority of regulations required by section 
520(g) to make a determination of whether there is a reasonable 
assurance of safety and effectiveness of a device subject to a pending 
application under this section if— 
"(I) the data or information is derived fi"om investigations 
of an earlier version of the device, the device has been modified 
during or after the investigations (but prior to submission of 
an application under subsection (c)) and such a modification 
of the device does not constitute a significant change in the 
design or in the basic principles of operation of the device 
that would invalidate the data or information; or 
"(II) the data or information relates to a device approved 
under this section, is available for use under this Act, and 
is relevant to the design and intended use of the device for 
which the application is pending.". 
SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES. 
Section 515(d) (21 U.S.C. 360e(d)) is amended— 
(1) by redesignating paragraph (3) as paragraph (4); and 
(2) by adding at the end the following: 
"(5) In order to provide for more effective treatment or diagnosis 
of life-threatening or irreversibly debilitating human diseases or 
conditions, the Secretary shall provide review priority for devices— 
"(A) representing breakthrough technologies, 
"(B) for which no approved alternatives exist, 
"(C) which offer significant advantages over existing 
approved alternatives, or 
"(D) the availability of which is in the best interest of 
the patients.". 
SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES. 
Section 520(m) (21 U.S.C. 360j(m)) is amended— 
(1) in paragraph (2), by adding after and below subpara-
graph (C) the following sentences: 
"The request shall be in the form of an application submitted 
to the Secretary. Not later than 75 days after the date of the 
receipt of the application, the Secretary shall issue an order approv-
ing or denjdng the application."; 
(2) in paragraph (4)— 
(A) in subparagraph (B), by inserting after "(2)(A)" 
the following: ", unless a physician determines in an emer-
gency situation that approval fi-om a local institutional 
review committee can not be obtained in time to prevent 
serious harm or death to a patient"; and 
(B) by adding after and below subparagraph (B) the 
following: 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2335 
"In a case described in subparagraph (B) in which a physician 
uses a device without an approval from an institutional review 
committee, the physician shall, after the use of the device, notify 
the chairperson of the local institutional review committee of such 
use. Such notification shall include the identification of the patient 
involved, the date on which the device was used, and the reason 
for the use."; 
(3) by amending paragraph (5) to read as follows: 
"(5) The Secretary may require a person granted an exemption 
under paragraph (2) to demonstrate continued compliance with 
the requirements of this subsection if the Secretary believes such 
demonstration to be necessary to protect the public health or if 
the Secretary has reason to believe that the criteria for the exemp-
tion are no longer met."; and 
(4) by amending paragraph (6) to read as follows: 
"(6) The Secretary may suspend or withdraw an exemption 
from the effectiveness requirements of sections 514 and 515 for 
a humanitarian device only after providing notice and an oppor-
tunity for an informal hearing.". 
SEC. 204. DEVICE STANDARDS. 
(a) ALTERNATIVE PROCEDURE.—Section 514 (21 U.S.C. 360d) 
is amended by adding at the end the following: 
"Recognition of a Standard 
"(c)(1)(A) In addition to establishing a performance standard 
Federal Register, 
under this section, the Secretary shall, by publication in the Federal publication. 
Register, recognize all or part of an appropriate standard estab-
lished by a nationally or internationally recognized standard devel-
opment organization for which a person may submit a declaration 
of conformity in order to meet a premarket submission requirement 
or other requirement under this Act to which such standard is 
applicable. 
"(B) If a person elects to use a standard recognized by the 
Secretary under subparagraph (A) to meet the requirements 
described in such subparagraph, the person shall provide a declara-
tion of conformity to the Secretary that certifies that the device 
is in conformity with such standard. A person may elect to use 
data, or information, other than data required by a standard recog-
nized under subparagraph (A) to meet any requirement regarding 
devices under this Act. 
"(2) The Secretary may withdraw such recognition of a standard 
Federal Register, 
through publication of a notice in the Federal Register if the Sec- publication, 
retary determines that the standard is no longer appropriate for 
meeting a requirement regarding devices under this Act. 
"(3XA) Subject to subparagraph (B), the Secretary shall accept 
a declaration of conformity that a device is in conformity with 
a st£indard recognized under paragraph (1) unless the Secretary 
finds— 
"(i) that the data or information submitted to support such 
declaration does not demonstrate that the device is in conform-
ity with the standard identified in the declaration of conformity; 
or 
"(ii) that the standard identified in the declaration of 
conformity is not applicable to the particular device under 
review. 
Ill STAT. 2336 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(B) The Secretary may request, at any time, the data or 
information rehed on by the person to make a declaration of 
conformity with respect to a standard recognized under paragraph 
(1). 
"(C) A person making a declaration of conformity with respect 
to a standard recognized under paragraph (1) shall maintain the 
data and information demonstrating conformity of the device to 
the standard for a period of two years after the date of the classifica-
tion or approval of the device by the Secretary or a period equal 
to the expected design life of the device, whichever is longer.". 
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is amended 
by adding at the end the following: 
"(x) The falsification of a declaration of conformity submitted 
under section 514(c) or the failure or refusal to provide data or 
information requested by the Secretary under paragraph (3) of 
such section ". 
(c) SECTION 501.—Section 501(e) (21 U.S.C. 351(e)) is amend-
ed— 
(1) by striking "(e)" and inserting "(e)(1)"; and 
(2) by inserting at the end the following: 
"(2) If it is declared to be, purports to be, or is represented 
as, a device that is in conformity with any standard recognized 
under section 514(c) unless such device is in all respects in conform-
ity with such standard.". 
(d) CONFORMING AMENDMENTS.—Section 514(a) (21 U.S.C. 
360d(a)) is amended— 
(1) in paragraph (1), in the second sentence, by striking 
"under this section" and inserting "imder subsection (b)"; 
(2) in paragraph (2), in the matter preceding subparagraph 
(A), by striking "under this section" and inserting "under sub-
section (b)"; 
(3) in paragraph (3), by striking "under this section" and 
inserting "under subsection (b)"; and 
(4) in paragraph (4), in the matter preceding subparagraph 
(A), by striking "this section" and inserting "this subsection 
and subsection (b)". 
SEC. 205. SCOPE OF REVIEW; COLLABORATIVE DETERMINATIONS OF 
DEVICE DATA REQUIREMENTS. 
(a) SECTION 513(a).—Section 513(a)(3) (21 U.S.C. 360c(a)(3)) 
is amended by adding at the end the following: 
"(C) In making a determination of a reasonable assurance of 
the effectiveness of a device for which an application under section 
515 has been submitted, the Secretary shall consider whether the 
extent of data that otherwise would be required for approval of 
the application with respect to effectiveness can be reduced through 
reliance on postmarket controls. 
"(D)(i) The Secretary, upon the written request of any person 
intending to submit an application luider section 515, shall meet 
with such person to determine the type of valid scientific evidence 
(within the meaning of subparagraphs (A) and (B)) that will be 
necessary to demonstrate for purposes of approval of an application 
the effectiveness of a device for the conditions of use proposed 
by such person. The written request shall include a detailed descrip-
tion of the device, a detailed description of the proposed conditions 
of use of the device, a proposed plan for determining whether 
there is a reasonable assurance of effectiveness, and, if available. 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2337 
information regarding the expected performance from the device. 
Within 30 days after such meeting, the Secretary shall specify 
in writing the type of valid scientific evidence that will provide 
a reasonable assurance that a device is effective under the condi-
tions of use proposed by such person. 
"(ii) Any clinical data, including one or more well-controlled 
investigations, specified in writing by the Secretary for demonstrat-
ing a reasonable assurance of device effectiveness shall be specified 
as result of a determination by the Secretary that such data are 
necessary to establish device effectiveness. The Secretary shall con-
sider, in consultation with the applicant, the least burdensome 
appropriate means of evaluating device effectiveness that would 
have a reasonable likelihood of resulting in approval. 
"(iii) The determination of the Secretary with respect to the 
specification of valid scientific evidence under clauses (i) and (ii) 
shall be binding upon the Secretary, unless such determination 
by the Secretary could be contrary to the public health.". 
(b) SECTION 513(i).—Section 513(i)(l) (21 U.S.C. 360c(i)(l)) is 
amended by adding at the end the following: 
"(C) To facilitate reviews of reports submitted to the Secretary 
under section 510(k), the Secretary shall consider the extent to 
which reliance on postmarket controls may expedite the classifica-
tion of devices under subsection (f)(1) of this section. 
"(D) Whenever the Secretary requests information to dem-
onstrate that devices with differing technological characteristics 
are substantially equivalent, the Secretary shall only request 
information that is necessary to making substantial equivalence 
determinations. In making such request, the Secretary shall con-
sider the least burdensome means of demonstrating substantial 
equivalence and request information accordingly. 
"(E)(i) Any determination by the Secretary of the intended 
use of a device shall be based upon the proposed labeling submitted 
in a report for the device imder section 510(k). However, when 
determining that a device can be foimd substantially equivalent 
to a legally marketed device, the director of the organizational 
unit responsible for regulating devices (in this subparagraph 
referred to as the 'Director') may require a statement in labeling 
that provides appropriate information regarding a use of the device 
not identified in the proposed labeling if, after providing an oppor-
tunity for consultation with the person who submitted such report, 
the Director determines and states in writing— 
"(I) that there is a reasonable likelihood that the device 
will be used for an intended use not identified in the proposed 
labeling for the device; and 
"(II) that such use could cause harm. 
"(ii) Such determination shall— 
"(I) be provided to the person who submitted the report 
within 10 days from the date of the notification of the Director's 
concerns regarding the proposed labeling; 
"(II) specify the limitations on the use of the device not 
included in the proposed labeling; and 
"(III) find the device substantially equivalent if the require-
ments of subparagraph (A) are met and if the labeling for 
such device conforms to the limitations specified in subclause 
(II). 
"(iii) The responsibilities of the Director under this subpara-
graph may not be delegated. 
I l l STAT. 2338 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(iv) This subparagraph has no legal effect after the expiration 
of the five-year period beginning on the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997.". 
(c) SECTION 515(d).—Section 515(d) (21 U.S.C. 360e(d)) is 
amended— 
(1) in paragraph (1)(A), by adding after and below clause 
(ii) the following: 
"In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use 
included in the proposed labeling as the basis for determining 
whether or not there is a reasonable assurance of safety and 
effectiveness, if the proposed labeling is neither false nor mislead-
ing. In determining whether or not such labeling is false or mislead-
ing, the Secretary shall fairly evaluate all material facts pertinent 
to the proposed labeling."; and 
(2) by adding after paragraph (5) (as added by section 
202(2)) the following: 
"(6)(A)(i) A supplemental application shall be required for any 
change to a device subject to an approved application under this 
subsection that affects safety or effectiveness, imless such change 
is a modification in a manufacturing procedure or method of manu-
facturing and the holder of the approved application submits a 
written notice to the Secretary that describes in detail the change, 
summarizes the data or information supporting the change, and 
informs the Secretary that the change has been made under the 
requirements of section 520(f). 
"(ii) The holder of an approved application who submits a 
notice under clause (i) with respect to a manufacturing change 
of a device may distribute the device 30 days after the date on 
which the Secretary receives the notice, unless the Secretary within 
such 30-day period notifies the holder that the notice is not adequate 
Eind describes such further information or action that is required 
for acceptance of such change. If the Secretary notifies the holder 
that a supplemental application is required, the Secretary shall 
review the supplement within 135 days after the receipt of the 
supplement. The time used by the Secretary to review the notice 
of the manufacturing change shall be deducted from the 135-day 
review period if the notice meets appropriate content requirements 
for premarket approval supplements. 
"(B)(i) Subject to clause (ii), in reviewing a supplement to 
an approved application, for an incremental change to the design 
of a device that affects safety or effectiveness, the Secretary shall 
approve such supplement if— 
"(I) nonclinical data demonstrate that the design modifica-
tion creates the intended additional capacity, function, or 
performance of the device; and 
"(II) clinical data from the approved application and any 
supplement to the approved application provide a reasonable 
assurance of safety and effectiveness for the changed device. 
"(ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification of the device to 
provide a reasonable assurance of safety and effectiveness.". 
SEC. 206. PREMARKET NOTIFICATION. 
(a) SECTION 510.—Section 510 (21 U.S.C. 360) is amended— 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2339 
(1) in subsection (k), in the matter preceding paragraph 
(1), by adding after "report to the Secretary" the following: 
"or person who is accredited under section 523(a)"; and 
(2) by adding at the end the following subsections: 
"(1) A report under subsection (k) is not required for a device 
intended for human use that is exempted from the requirements 
of this subsection under subsection (m) or is within a type that 
has been classified into class I under section 513. The exception 
established in the preceding sentence does not apply to any class 
I device that is intended for a use which is of substantial importance 
in preventing impairment of human health, or to any class I device 
that presents a potential unreasonable risk of illness or injury. 
"(m)(l) Not later than 60 days after the date of enactment 
of the Food and Drug Administration Modernization Act of 1997, 
the Secretary shall publish in the Federal Register a list of each 
type of class II device that does not require a report under sub-
section (k) to provide reasonable assurance of safety and effective-
ness. Each t3rpe of class II device identified by the Secretary as 
not requiring the report shall be exempt from the requirement 
to provide a report under subsection (k) as of the date of the 
publication of the list in the Federal Register. 
"(2) Beginning on the date that is 1 day after the date of 
the publication of a list under this subsection, the Secretary may 
exempt a class II device fi-om the requirement to submit a report 
under subsection (k), upon the Secretary's own initiative or a peti-
tion of an interested person, if the Secretary determines that such 
report is not necessary to assure the safety and effectiveness of 
the device. The Secretary shall publish in the Federal Register 
notice of the intent of the Secretary to exempt the device, or 
of the petition, and provide a 30-day period for public comment. 
Within 120 days after the issuance of the notice in the Federal 
Register, the Secretary shall publish an order in the Federal Reg-
ister that sets forth the final determination of the Secretary regard-
ing the exemption of the device that was the subject of the notice. 
If the Secretary fails to respond to a petition within 180 days 
of receiving it, the petition shall be deemed to be granted.". 
(b) SECTION 513(f).—Section 513(f) (21 U.S.C. 360c(f)) is amend-
ed by adding at the end the following: 
"(5) The Secretary may not withhold a determination of the 
initial classification of a device luider paragraph (1) because of 
a failure to comply with any provision of this Act unrelated to 
a substantial equivalence decision, including a finding that the 
facility in which the device is manufactured is not in compliance 
with good manufacturing requirements as set forth in regulations 
of the Secretary under section 520(f) (other than a finding that 
there is a substantial likelihood that the failure to comply with 
such regulations will potentially present a serious risk to human 
health).". 
(c) SECTION 513(i).—Section 513(i)(l) (21 U.S.C. 360c(i)), as 
amended by section 205(b), is amended— 
(1) in subparagraph (A)(ii)— 
(A) in subclause (I), by striking "clinical data" and 
inserting "appropriate clinical or scientific data" and by 
inserting "or a person accredited under section 523" after 
"Secretary"; and 
(B) in subclause (II), by striking "efficacy" and inserting 
"effectiveness"; and 
Federal Register, 
publication. 
Federal Register, 
publication. 
Federal Register, 
publication. 
I l l STAT. 2340 
PUBLIC LAW 105-115—NOV. 21, 1997 
(2) by adding at the end the following: 
"(F) Not later than 270 days after the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997, 
the Secretary shall issue guidance specifying the general principles 
that the Secretary will consider in determining when a specific 
intended use of a device is not reasonably included within a general 
use of such device for purposes of a determination of substantial 
equivalence under subsection (f) or section 520(1).". 
SEC. 207. EVALUATION OF AUTOMATIC CLASS in DESIGNATION. 
Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b), 
is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (B), by striking "paragraph (2)" 
and inserting "paragraph (3)"; and 
(B) in the last sentence, by striking "paragraph (2)" 
and inserting "paragraph (2) or (3)"; 
(2) by redesignating paragraphs (2) and (3) as paragraphs 
(3) and (4), respectively; and 
(3) by inserting after paragraph (1) the following: 
"(2)(A) Aiy person who submits a report under section 510(k) 
for a type of device that has not been previously classified under 
this Act, and that is classified into class III under paragraph 
(1), may request, within 30 days after receiving written notice 
of such a classification, the Secretary to classify the device under 
the criteria set forth in subparagraphs (A) through (C) of subsection 
(a)(1). The person may, in the request, recommend to the Secretary 
a classification for the device. Any such request shall describe 
the device and provide detailed information and reasons for the 
recommended classification. 
"(B)(i) Not later than 60 days after the date of the submission 
of the request under subparagraph (A), the Secretary shall by 
written order classify the device involved. Such classification shall 
be the initial classification of the device for purposes of paragraph 
(1) and any device classified under this paragraph shall be a predi-
cate device for determining substantial equivalence under para-
graph (1). 
"(ii) A device that remains in class III under this subparagraph 
shall be deemed to be adulterated within the meaning of section 
501(f)(1)(B) until approved under section 515 or exempted from 
such approval under section 520(g). 
Federal Register, 
"(C) Within 30 days after the issuance of an order classifying 
publication. 
a device under this paragraph, the Secretary shall publish a notice 
in the Federal Register announcing such classification.". 
SEC. 208. CLASSIFICATION PANELS. 
Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at 
the end the following: 
"(5) Classification panels covering each t3rpe of device shall 
be scheduled to meet at such times as may be appropriate for 
the Secretary to meet applicable statutory deadlines. 
"(6)(A) Any person whose device is specifically the subject of 
review by a classification panel shall have— 
"(i) the same access to data and information submitted 
to a classification panel (except for data £uid information that 
are not available for public disclosure under section 552 of 
title 5, United States Code) as the Secretary; 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2341 
"(ii) the opportunity to submit, for review by a classification 
panel, information that is based on the data or information 
provided in the application submitted under section 515 by 
the person, which information shall be submitted to the Sec-
retary for prompt transmittal to the classification panel; and 
"(iii) the same opportunity as the Secretary to participate 
in meetings of the panel. 
"(B) Any meetings of a classification panel shall provide ade-
quate time for initial presentations and for response to any differing 
views by persons whose devices are specifically the subject of a 
classification panel review, and shall encourage free and open 
participation by all interested persons. 
"(7) After receiving from a classification panel the conclusions 
and recommendations of the panel on a matter that the panel 
has reviewed, the Secretary shall review the conclusions and rec-
ommendations, shall make a final decision on the matter in accord-
ance with section 515(d)(2), and shall notify the affected persons 
of the decision in writing and, if the decision differs fi'om the 
conclusions and recommendations of the panel, shall include the 
reasons for the difference. 
"(8) A classification panel iinder this subsection shall not be 
subject to the annual chartering and annual report requirements 
of the Federal Advisory Committee Act.". 
SEC. 209. CERTAINTY OF REVIEW TIMEFRAMES; 
COLLABORATIVE 
REVIEW PROCESS. 
(a) CERTAINTY OF REVIEW TIMEFRAMES.—Section 510 (21 U.S.C. 
360), as amended by section 206(a)(2), is amended by adding at 
the end the following subsection: 
"(n) The Secretary shall review the report required in subsection 
(k) and make a determination under section 513(f)(1) not later 
than 90 days after receiving the report.". 
(b) 
COLLABORATIVE 
REVIEW 
PROCESS.—Section 515(d) (21 
U.S.C. 360e(d)), as amended by section 202(1), is amended by insert-
ing after paragraph (2) the following: 
"(3)(A)(i) The Secretary shall, upon the written request of an 
applicant, meet with the applicant, not later than 100 days after 
the receipt of an application that has been filed as complete under 
subsection (c), to discuss the review status of the application. 
"(ii) The Secretary shall, in writing and prior to the meeting, 
provide to the applicant a description of any deficiencies in the 
application that, at that point, have been identified by the Secretary 
based on an interim review of the entire application and identify 
the information that is required to correct those deficiencies. 
"(iii) The Secretary shall notify the applicant promptly of— 
"(I) any additional deficiency identified in the application, 
or 
"(II) any additional information required to achieve comple-
tion of the review and final action on the application, 
that was not described as a deficiency in the written description 
provided by the Secretary under clause (ii). 
"(B) The Secretary and the applicant may, by mutual consent, 
establish a different schedule for a meeting required under this 
paragraph. 
I l l STAT. 2342 
PUBLIC LAW 105-115—NOV. 21, 1997 
SEC. 210. ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET 
NOTIFICATION REPORTS. 
(a) IN GENERAL.—Subchapter A of chapter V is amended by 
adding at the end the following: 
21 use 360m. 
"SEC. 523. ACCREDITED PERSONS. 
"(a) IN GENERAL.— 
"(1) REVIEW AND CLASSIFICATION OF DEVICES.—Not later 
than 1 year after the date of the enactment of the Food and 
Drug Administration Modernization Act of 1997, the Secretary 
shall, subject to paragraph (3), accredit persons for the purpose 
of reviewing reports submitted under section 510(k) and making 
recommendations to the Secretary regarding the initial classi-
fication of devices under section 513(f)(1). 
"(2) REQUIREMENTS REGARDING REVIEW.— 
"(A) IN GENERAL.—In making a recommendation to 
the Secretary under paragraph (1), an accredited person 
shall notify the Secretary in writing of the reasons for 
the recommendation. 
"(B) TIME PERIOD FOR REVIEW.—Not later than 30 days 
after the date on which the Secretary is notified under 
subparagraph (A) by an accredited person with respect 
to a recommendation of an initial classification of a device, 
the Secretary shall make a determination with respect 
to the initial classification. 
"(C) SPECIAL RULE.—The Secretary may change the 
initial classification under section 513(f)(1) that is rec-
ommended imder paragraph (1) by an accredited person, 
and in such case shall provide to such person, and the 
person who submitted the report under section 510(k) for 
the device, a statement explaining in detail the reasons 
for the change. 
"(3) CERTAIN DEVICES.— 
"(A) IN GENERAL.—An accredited person may not be 
used to perform a review of— 
"(i) a class III device; 
"(ii) a class II device which is intended to be perma-
nently implantable or life sustaining or life supporting; 
or 
"(iii) a class II device which requires clinical data 
in the report submitted under section 510(k) for the 
device, except that the number of class II devices to 
which the Secretary applies this clause for a year, 
less the number of such reports to which clauses (i) 
and (ii) apply, may not exceed 6 percent of the number 
that is equal to the total number of reports submitted 
to the Secretary under such section for such year less 
the number of such reports to which such clauses apply 
for such year. 
"(B) ADJUSTMENT.—In determining for a year the ratio 
described in subparagraph (A)(iii), the Secretary shall not 
include in the numerator class III devices that the Sec-
retary reclassified into class II, and the Secretary shall 
include in the denominator class II devices for which 
reports under section 510(k) were not required to be 
submitted by reason of the operation of section 510(m). 
"(b) ACCREDITATION.— 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2343 
"(1) PROGRAMS.—^The Secretary shall provide for such 
accreditation through programs administered by the Food and 
Drug Administration, other government agencies, or by other 
qualified nongovernment organizations. 
"(2) ACCREDITATION.— 
"(A) IN GENERAL.—Not later than 180 days after the Federal Register, 
date of the enactment of the Food and Drug Administration 
publication. 
Modernization Act of 1997, the Secretary shall establish 
and publish in the Federal Register criteria to accredit 
or deny accreditation to persons who request to perform 
the duties specified in subsection (a). The Secretary shall 
respond to a request for accreditation within 60 days of 
the receipt of the request. The accreditation of such person 
shall specify the particular activities under subsection (a) 
for which such person is accredited. 
"(B) WITHDRAWAL OF ACCREDITATION.—The Secretary 
may suspend or withdraw accreditation of any person 
accredited under this paragraph, after providing notice and 
an opportunity for an informal hearing, when such person 
is substantially not in compliance with the requirements 
of this section or poses a threat to public health or fails 
to act in a manner that is consistent with the purposes 
of this section. 
"(C) PERFORMANCE AUDITING.—TO ensure that persons 
accredited under this section will continue to meet the 
standards of accreditation, the Secretary shall— 
"(i) make onsite visits on a periodic basis to each 
accredited person to audit the performance of such 
person; and 
"(ii) take such additional measures as the Sec-
retary determines to be appropriate. 
"(D) ANNUAL REPORT.—The Secretary shall include in 
the annual report required under section 903(g) the names 
of all accredited persons and the particular activities under 
subsection (a) for which each such person is accredited 
and the name of each accredited person whose accreditation 
has been withdrawn during the year. 
"(3) QUALIFICATIONS.—An accredited person shall, at a 
minimum, meet the following requirements: 
"(A) Such person may not be an employee of the Fed-
eral Government. 
"(B) Such person shall be an independent orgemization 
which is not owned or controlled by a manufacturer, sup-
plier, or vendor of devices and which has no organizational, 
material, or financial affiliation with such a manufacturer, 
supplier, or vendor. 
"(C) Such person shall be a legally constituted entity 
permitted to conduct the activities for which it seeks 
accreditation. 
"(D) Such person shall not engage in the design, manu-
facture, promotion, or sale of devices. 
"(E) The operations of such person shall be in accord-
ance with generally accepted professional sind ethical busi-
ness practices and shall agree in writing that as a minimum 
it will— 
"(i) certify that reported information accurately 
reflects data reviewed; 
I l l STAT. 2344 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(ii) limit work to that for which competence and 
capacity are available; 
"(iii) treat information received, records, reports, 
and recommendations as proprietary information; 
"(iv) promptly respond and attempt to resolve com-
plaints regarding its activities for which it is accred-
ited; and 
"(v) protect against the use, in carrying out sub-
section (a) with respect to a device, of any officer or 
employee of the person who has a financial conflict 
of interest regarding the device, and annually make 
available to the public disclosures of the extent to 
which the person, and the officers and employees of 
the person, have maintained compliance with require-
ments under this clause relating to financial conflicts 
of interest. 
"(4) SELECTION OF ACCREDITED PERSONS.—The Secretary 
shall provide each person who chooses to use an accredited 
person to receive a section 510(k) report a panel of at least 
two or more accredited persons from which the regulated person 
may select one for a specific regulatory function. 
"(5) COMPENSATION OF ACCREDITED PERSONS.—Compensa-
tion for an accredited person shall be determined by agreement 
between the accredited person and the person who engages 
the services of the accredited person, and shall be paid by 
the person who engages such services. 
"(c) DURATION.—Tlie authority provided by this section termi-
nates— 
"(1) 5 years after the date on which the Secretary notifies 
Congress that at least 2 persons accredited under subsection 
(b) are available to review at least 60 percent of the submissions 
under section 510(k), or 
"(2) 4 years after the date on which the Secretary notifies 
Congress that the Secretary has made a determination 
described in paragraph (2)(B) of subsection (a) for at least 
35 percent of the devices that are subject to review under 
paragraph (1) of such subsection, 
whichever occurs first.". 
(b) RECORDKEEPING.—Section 704 (21 U.S.C. 374) is amended 
by adding at the end the following: 
"(f)(1) A person accredited under section 523 to review reports 
made under section 510(k) and make recommendations of initial 
classifications of devices to the Secretary shall maintain records 
documenting the training qualifications of the person and the 
employees of the person, the procedures used by the person for 
handling confidential information, the compensation arrangements 
made by the person, and the procedures used by the person to 
identify and avoid conflicts of interest. Upon the request of an 
officer or employee designated by the Secretary, the person shall 
permit the officer or employee, at all reasonable times, to have 
access to, to copy, and to verify, the records. 
"(2) Within 15 days after the receipt of a written request 
from the Secretary to a person accredited under section 523 for 
copies of records described in paragraph (1), the person shall 
produce the copies of the records at the place designated by the 
Secretary.". 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2345 
(c) CONFORMING AMENDMENT.—Section 301 (21 U.S.C. 
331), 
as amended by section 204(b), is amended by adding at the end 
the following: 
"(y) In the case of a drug, device, or food— 
"(1) the submission of a report or recommendation by a 
person accredited under section 523 that is false or misleading 
in any material respect; 
"(2) the disclosure by a person accredited under section 
523 of confidential commercial information or any trade secret 
without the express written consent of the person who submit-
ted such information or secret to such person; or 
"(3) the receipt by a person accredited under section 523 
of a bribe in any form or the doing of any corrupt act by 
such person associated with a responsibility delegated to such 
person under this Act.". 
(d) REPORTS ON PROGRAM OF ACCREDITATION.— 
21 use 3
6
0
m 
(1) COMPTROLLER GENERAL.— 
i^ote. 
(A) IMPLEMENTATION OF PROGRAM.—Not later than 5 
years after the date of the enactment of this Act, the 
Comptroller General of the United States shall submit 
to the Committee on Commerce of the House of Representa-
tives and the Committee on Labor and Human Resources 
of the Senate a report describing the extent to which the 
program of accreditation required by the amendment made 
by subsection (a) has been implemented. 
(B) 
EVALUATION 
OF PROGRAM.—Not later than 6 
months prior to the date on which, pursuant to subsection 
(c) of section 523 of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a)), the authority provided 
under subsection (a) of such section will terminate, the 
Comptroller General shall submit to the Committee on 
Commerce of the House of Representatives £ind the 
Committee on Labor and Human Resources of the Senate 
a report describing the use of accredited persons under 
such section 523, including an evaluation of the extent 
to which such use assisted the Secretary in carrying out 
the duties of the Secretary under such Act with respect 
to devices, and the extent to which such use promoted 
actions which are contrary to the purposes of such Act. 
(2) INCLUSION OF CERTAIN DEVICES WITHIN PROGRAM.—Not 
later than 3 years after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall submit 
to the Committee on Commerce of the House of Representatives 
and the Committee on Labor and Human Resources of the 
Senate a report providing a determination by the Secretary 
of whether, in the program of accreditation established pursu-
ant to the amendment made by subsection (a), the limitation 
established in clause (iii) of section 523(a)(3)(A) of the Federal 
Food, Drug, and Cosmetic Act (relating to class II devices 
for which clinical data are required in reports under section 
510(k)) should be removed. 
SEC. 211. DEVICE TRACKING. 
Effective 90 days after the date of the enactment of this Act, 
section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows: 
39-194 O - 97 - 9 : QL 3 Part 3 
I l l STAT. 2346 
PUBLIC LAW 105-115—NOV. 21, 1997 
"Device Tracking 
"(e)(1) The Secretary may by order require a manufacturer 
to adopt a method of tracking a class II or class III device— 
"(A) the failure of which would be reasonably likely to 
have serious adverse health consequences; or 
"(B) which is— 
"(i) intended to be implanted in the human body for 
more than one year, or 
"(ii) a life sustaining or life supporting device used 
outside a device user facility. 
"(2) Any patient receiving a device subject to tracking under 
paragraph (1) may refuse to release, or refuse permission to release, 
the patient's name, address, social security number, or other identi-
fying information for the purpose of tracking.", 
SEC. 212. POSTMARKET SURVEILLANCE. 
Effective 90 days after the date of the enactment of this Act, 
section 522 (21 U.S.C. 3601) is amended to read as follows: 
"POSTMARKET SURVEILLANCE 
"SEC. 522. (a) IN GENERAL.—The Secretary may by order 
require a manufacturer to conduct postmarket surveillance for any 
device of the manufacturer which is a class II or class III device 
the failure of which would be reasonably likely to have serious 
adverse health consequences or which is intended to be— 
"(1) implanted in the humaui body for more than one year, 
or 
"(2) a life sustaining or life supporting device used outside 
a device user facility, 
"(b) SURVEILLANCE APPROVAL.—Each manufacturer required to 
conduct a surveillance of a device shall, within 30 days of receiving 
an order from the Secretary prescribing that the manufacturer 
is required under this section to conduct such surveillance, submit, 
for the approval of the Secretary, a plan for the required surveil-
lance. The Secretary, within 60 days of the receipt of such plan, 
shall determine if the person designated to conduct the surveillance 
has appropriate qualifications and experience to undertake such 
surveillance and if the plan will result in the collection of useful 
data that can reveal unforeseen adverse events or other information 
necessary to protect the public health. The Secretary, in consulta-
tion with the manufacturer, may by order require a prospective 
surveillance period of up to 36 months. Any determination by the 
Secretary that a longer period is necessary shall be made by mutual 
agreement between the Secretary and the manufacturer or, if no 
agreement can be reached, after the completion of a dispute resolu-
tion process as described in section 562,", 
SEC. 213. REPORTS. 
(a) REPORTS,—Section 519 (21 U,S,C. 360i) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), by striking 
"manufacturer, importer, or distributor" and inserting 
"manufacturer or importer"; 
(B) in paragraph (4), by striking 
"manufacturer, 
importer, or distributor" and inserting "manufacturer or 
importer"; 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2347 
(C) in paragraph (7), by adding "and" after the semi-
colon at the end; 
(D) in paragraph (8)— 
(i) by striking "manufacturer, importer, or distribu-
tor" each place such term appears and inserting "manu-
facturer or importer"; and 
(ii) by striking the semicolon at the end and insert-
ing a period; 
(E) by striking paragraph (9); and 
(F) by inserting at the end the following sentence: 
"The Secretary shall by regulation require distributors to 
keep records and make such records available to the Sec-
retary upon request. Paragraphs (4) and (8) apply to 
distributors to the same extent and in the same manner 
as such paragraphs apply to manufacturers and import-
ers."; 
(2) by striking subsection (d); and 
(3) in subsection (f), by striking ", importer, or distributor" 
each place it appears and inserting "or importer". 
(b) REGISTRATION.—Section 510(g) (21 U.S.C. 360(g)) is amend-
ed— 
(1) by redesignating paragraph (4) as paragraph (5); 
(2) by inserting after paragraph (3) the following: 
"(4) any distributor who acts as a wholesale distributor 
of devices, and who does not manufacture, repackage, process, 
or relabel a device; or"; and 
(3) by adding at the end the following flush sentence: 
"In this subsection, the term 'wholesale distributor' means any 
person (other than the manufacturer or the initial importer) who 
distributes a device from the original place of manufacture to the 
person who makes the final delivery or sale of the device to the 
ultimate consumer or user.". 
(c) DEVICE USER FACILITIES.— 
(1) IN GENERAL.—Section 519(b) (21 U.S.C. 360i(b)) is 
amended— 
(A) in paragraph (1)(C)— 
(i) in the first sentence, by striking "a semi-annual 
basis" and inserting "an annual basis"; 
(ii) in the second sentence, by striking "and July 
1"; and 
(iii) by striking the matter after and below clause 
(iv); and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by inserting "or" after 
the comma at the end; 
(ii) in subparagraph (B), by striking ", or" at the 
end and inserting a period; and 
(iii) by striking subparagraph (C). 
(2) SENTINEL SYSTEM.—Section 519(b) (21 U.S.C. 360i(b)) 
is amended— 
(A) by redesignating paragraph (5) as paragraph (6); 
and 
(B) by inserting after paragraph (4) the following para-
graph: 
"(5) With respect to device user facilities: 
"(A) The Secretary shall by regulation plan and implement 
a program under which the Secretary limits user reporting 
I l l STAT. 2348 
PUBLIC LAW 105-115—NOV. 21, 1997 
under paragraphs (1) through (4) to a subset of user faciUties 
that constitutes a representative profile of user reports for 
device deaths and serious illnesses or serious injuries. 
"(B) During the period of planning the program under 
subparagraph (A), paragraphs (1) through (4) continue to apply. 
"(C) During the period in which the Secretary is providing 
for a transition to the full implementation of the program, 
paragraphs (1) through (4) apply except to the extent that 
the Secretary determines otherwise. 
"(D) On and after the date on which the program is fully 
implemented, paragraphs (1) through (4) do not apply to a 
user facility unless the facility is included in the subset referred 
to in subparagraph (A), 
"(E) Not later than 2 years after the date of the enactment 
of the Food and Drug Administration Modernization Act of 
1997, the Secretary shall submit to the Committee on Com-
merce of the House of Representatives, and to the Committee 
on Labor and Human Resources of the Senate, a report describ-
ing the plan developed by the Secretary under subparagraph 
(A) and the progress that has been made toward 
the 
implementation of the plan.". 
SEC. 214. PRACTICE OF MEDICINE. 
Chapter IX is amended by adding at the end the following: 
21 use 396. 
"SEC. 906. PRACTICE OF MEDICINE. 
"Nothing in this Act shall be construed to limit or interfere 
with the authority of a health care practitioner to prescribe or 
administer any legally marketed device to a patient for any condi-
tion or disease within a legitimate health care practitioner-patient 
relationship. This section shall not limit any existing authority 
of the Secretary to establish and enforce restrictions on the sale 
or distribution, or in the labeling, of a device that are part of 
a determination of substantial equivalence, established as a condi-
tion of approval, or promulgated through regulations. Further, this 
section shall not change any existing prohibition on the promotion 
of unapproved uses of legally marketed devices.". 
SEC. 215. NONINVASIVE BLOOD GLUCOSE METER. 
(a) FINDINGS.—The Congress finds that^-
(1) diabetes and its complications are a leading cause of 
death by disease in America; 
(2) diabetes affects approximately 16,000,000 Americans 
and another 650,000 will be diagnosed in 1997; 
(3) the total health care-related costs of diabetes total 
nearly $100,000,000,000 per year; 
(4) diabetes is a disease that is managed and controlled 
on a daily basis by the patient; 
(5) the failure to properly control and manage diabetes 
results in costly and often fatal complications including but 
not limited to blindness, coronary artery disease, and kidney 
failure; 
(6) blood testing devices are a critical tool for the control 
and management of diabetes, and existing blood testing devices 
require repeated piercing of the skin; 
(7) the pain associated with existing blood testing devices 
creates a disincentive for people with diabetes to test blood 
glucose levels, particularly children; 
'. ';iX-?^'.'j 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2349 
(8) a safe and effective noninvasive blood glucose meter 
would likely improve control and m£inagement of diabetes by 
increasing the nimiber of tests conducted by people with 
diabetes, particularly children; and 
(9) the Food and Drug Administration is responsible for 
reviewing all applications for new medical devices in the United 
States. 
(b) SENSE OF CONGRESS.—It is the sense of the Congress that 
the availability of a safe, effective, noninvasive blood glucose meter 
would greatly enhance the health and well-being of all people with 
diabetes across America and the world. 
SEC. 216. USE OF DATA RELATING TO PREMARKET APPROVAL; PROD-
UCT DEVELOPMENT PROTOCOL. 
(a) USE OF DATA RELATING TO PREMARKET APPROVAL.— 
(1) IN GENERAL.—Section 520(h)(4) (21 U.S.C. 360j(h)(4)) 
is amended to read as follows: 
"(4)(A) Any information contained in an application for pre-
market approval filed with the Secretary pursuant to section 515(c) 
(including information from clinical and preclinical tests or studies 
that demonstrate the safety and effectiveness of a device, but 
excluding descriptions of methods of manufacture and product com-
position and other trade secrets) shall be available, 6 years after 
the application has been approved by the Secretary, for use by 
the Secretary in— 
"(i) approving another device; 
"(ii) determining whether a product development protocol 
has been completed, under section 515 for another device; 
"(iii) establishing a performance standard or special control 
under this Act; or 
"(iv) classifying or reclassifying £mother device under sec-
tion 513 and subsection (1)(2). 
"(B) The publicly available detailed summaries of information 
respecting the safety and effectiveness of devices required by para-
graph (1)(A) shall be available for use by the Secretary as the 
evidentiary basis for the agency actions described in subparagraph 
(A).". 
(2) CONFORMING AMENDMENTS.—Section 517(a) (21 U.S.C. 
360g(a)) is amended— 
(A) in paragraph (8), by adding "or" at the end; 
(B) in paragraph (9), by striking ", or" and inserting 
a comma; and 
(C) by striking paragraph (10). 
(b) PRODUCT DEVELOPMENT PROTOCOL.—Section 515(f)(2) (21 
U.S.C. 360e(f)(2)) is amended by striking "he shall" and all that 
follows and inserting the following: "the Secretary— 
"(A) may, at the initiative of the Secretary, refer the pro-
posed protocol to the appropriate panel under section 513 for 
its recommendation respecting approval of the protocol; or 
"(B) shall so refer such protocol upon the request of the 
submitter, unless the Secretary finds that the proposed protocol 
and accompanying data which would be reviewed by such panel 
substantially duplicate a product development protocol and 
accompanjdng data which have previously been reviewed by 
such a panel.". 
I l l STAT. 2350 
PUBLIC LAW 105-115—NOV. 21, 1997 
SEC. 217. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
INVESTIGATIONS FOR APPROVAL. 
Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by 
striking "clinical investigations" and inserting "1 or more clinical 
investigations". 
TITLE III—IMPROVING REGULATION OF 
FOOD 
SEC. 301. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS. 
Section 403(r) (21 U.S.C. 343(r)) is amended by adding at 
the end the following: 
"(7) The Secretary may make proposed regulations issued under 
this paragraph effective upon publication pending consideration 
of public comment and publication of a final regulation if the 
Secretary determines that such action is necessary— 
"(A) to enable the Secretary to review and act promptly 
on petitions the Secretary determines provide for information 
necessary to— 
"(i) enable consumers to develop and maintain healthy 
dietary practices; 
"(ii) enable consumers to be informed promptly and 
effectively of important new knowledge regarding nutri-
tional and health benefits of food; or 
"(iii) ensure that scientifically sound nutritional and 
health information is provided to consumers as soon as 
possible; or 
"(B) to enable the Secretary to act promptly to ban or 
modify a claim under this paragraph. 
Such proposed regulations shall be deemed final agency action 
for purposes of 
judicial review.". 
SEC. 302. PETITIONS FOR CLAIMS. 
Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended— 
(1) by adding after the second sentence the following: "If 
the Secretary does not act within such 100 days, the petition 
shall be deemed to be denied unless an extension is mutually 
agreed upon by the Secretary and the petitioner."; 
(2) in the fourth sentence (as, amended by paragraph (1)) 
by inserting immediately before the comma the following: "or 
the petition is deemed to be denied"; and 
(3) by adding at the end the following: "If the Secretary 
does not act within such 90 days, the petition shall be deemed 
to be denied unless an extension is mutually agreed upon 
by the Secretary £ind the petitioner. If the Secretary issues 
a proposed regulation, the rulemaking shall be completed 
within 540 days of the date the petition is received by the 
Secretary. If the Secretary does not issue a regulation within 
such 540 days, the Secretary shall provide the Committee on 
Commerce of the House of Representatives and the Committee 
on Labor and Human Resources of the Senate the reasons 
action on the regulation did not occur within such 540 days.". 
SEC. 303. HEALTH CLAIMS FOR FOOD PRODUCTS. 
Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding 
at the end thereof the following: 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2351 
"(C) Notwithstanding the provisions of clauses (A)(i) and (B), 
a claim of the type described in subparagraph (1)(B) which is 
not authorized by the Secretary in a regulation promulgated in 
accordance with clause (B) shall be authorized and may be made 
with respect to a food if— 
"(i) a scientific body of the United States Government with 
official responsibility for public health protection or research 
directly relating to human nutrition (such as the National 
Institutes of Health or the Centers for Disease Control and 
Prevention) or the National Academy of Sciences or any of 
its subdivisions has published an authoritative statement, 
which is currently in effect, about the relationship between 
a nutrient and a disease or health-related condition to which 
the claim refers; 
"(ii) a person has submitted to the Secretary, at least 
120 days (during which the Secretary may notify any person 
who is making a claim as authorized by clause (C) that such 
person has not submitted all the information required by such 
clause) before the first introduction into interstate commerce 
of the food with a label containing the claim, (I) a notice 
of the claim, which shall include the exact words used in 
the claim and shall include a concise description of the basis 
upon which such person relied for determining that the require-
ments of subclause (i) have been satisfied, (II) a copy of the 
statement referred to in subclause (i) upon which such person 
relied in making the claim, and (III) a balanced representation 
of the scientific literature relating to the relationship between 
a nutrient and a disease or health-related condition to which 
the claim refers; 
"(iii) the claim and the food for which the claim is made 
are in compliance with clause (A)(ii) and are otherwise in 
compliance with paragraph (a) and section 201(n); and 
"(iv) the claim is stated in a manner so that the claim 
is an accurate representation of the authoritative statement 
referred to in subclause (i) and so that the claim enables 
the public to comprehend the information provided in the claim 
and to understand the relative significance of such information 
in the context of a total daily diet. 
For purposes of this clause, a statement shall be regarded as 
an authoritative statement of a scientific body described in sub-
clause (i) only if the statement is published by the scientific body 
and shall not include a statement of an employee of the scientific 
body made in the individual capacity of the employee. 
"(D) A claim submitted under the requirements of clause (C) 
may be made imtil— 
"(i) such time as the Secretary issues a regulation under 
the standard in clause (B)(i)— 
"(I) prohibiting or modif3dng the claim and the regula-
tion has become effective, or 
"(II) finding that the requirements of clause (C) have 
not been met, including finding that the petitioner has 
not submitted all the information required by such clause; 
or 
"(ii) a district court of the United States in an enforcement 
proceeding under chapter III has determined that the require-
ments of clause (C) have not been met.". 
I l l STAT. 2352 
PUBLIC LAW 105-115—NOV. 21, 1997 
SEC. 304. NUTRIENT CONTENT CLAIMS. 
Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding 
at the end the following: 
"(G) A claim of the t3^e described in subparagraph (1)(A) for 
a nutrient, for which the Secretary has not promulgated a regulation 
under clause (A)(i), shall be authorized and may be made with 
respect to a food if— 
"(i) a scientific body of the United States Government with 
official responsibility for public health protection or research 
directly relating to human nutrition (such as the National 
Institutes of Health or the Centers for Disease Control and 
Prevention) or the National Academy of Sciences or any of 
its subdivisions has published an authoritative statement, 
which is currently in effect, which identifies the nutrient level 
to which the claim refers; 
"(ii) a person has submitted to the Secretary, at least 
120 days (during which the Secretary may notify any person 
who is making a claim as authorized by clause (C) that such 
person has not submitted all the information required by such 
clause) before the first introduction into interstate commerce 
of the food with a label containing the claim, (I) a notice 
of the claim, which shall include the exact words used in 
the claim and shall include a concise description of the basis 
upon which such person relied for determining that the require-
ments of subclause (i) have been satisfied, (II) a copy of the 
statement referred to in subclause (i) upon which such person 
relied in making the claim, and (III) a balanced representation 
of the scientific literature relating to the nutrient level to 
which the claim refers; 
"(iii) the claim and the food for which the claim is made 
are in compliance with clauses (A) and (B), and are otherwise 
in compliance with paragraph (a) and section 201(n); and 
"(iv) the claim is stated in a manner so that the claim 
is an accurate representation of the authoritative statement 
referred to in subclause (i) and so that the claim enables 
the public to comprehend the information provided in the claim 
and to understand the relative significance of such information 
in the context of a total daily diet. 
For purposes of this clause, a statement shall be regarded as 
an authoritative statement of a scientific body described in sub-
clause (i) only if the statement is published by the scientific body 
and shall not include a statement of an employee of the scientific 
body made in the individual capacity of the employee. 
"(H) A claim submitted under the requirements of clause (G) 
may be made imtil— 
"(i) such time as the Secretary issues a regulation— 
"(I) prohibiting or modifying the claim and the regula-
tion has become effective, or 
"(II) finding that the requirements of clause (G) have 
not been met, including finding that the petitioner had 
not submitted all the information required by such clause; 
or 
"(ii) a district court of the United States in an enforcement 
proceeding under chapter III has determined that the require-
ments of clause (G) have not been met.". 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2353 
SEC. 305. REFERRAL STATEMENTS. 
Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read 
as follows: 
"(B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food and the Secretary makes a determina-
tion that the food contains a nutrient at a level that increases 
to persons in the general population the risk of a disease or health-
related condition that is diet related, the label or labeling of such 
food shall contain, prominently and in immediate proximity to 
such claim, the following statement: 'See nutrition information for 
content.' The blank shall identify the nutrient associated with 
the increased disease or health-related condition risk. In making 
the determination described in this clause, the Secretary shall 
take into account the significance of the food in the total daily 
diet.". 
SEC. 306. DISCLOSURE OF ffiRADL^TION. 
Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting 
after section 403B the following: 
"DISCLOSURE 
"SEC. 403C. (a) No provision of section 201(n), 403(a), or 409 21USC 343-3. 
shall be construed to require on the label or labeling of a food 
a separate radiation disclosure statement that is more prominent 
than the declaration of ingredients required by section 403(i)(2). 
"(b) In this section, the term 'radiation disclosure statement' 
means a written statement that discloses that a food has been 
intentionally subject to radiation.", 
SEC. 307. IRRADIATION PETITION. 
Not later than 60 days following the date of the enactment 
of this Act, the Secretary of Health and Human Services shall 
make a final determination on any petition pending with the Food 
and Drug Administration that would permit the irradiation of red 
meat under section 409(b)(1) of the Federal Food, Drug, and Cos-
metic Act. If the Secretary does not make such determination, 
the Secretary shall, not later than 60 days following the date 
of the enactment of this Act, provide the Committee on Commerce 
of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate an explanation of the process 
followed by the Food and Drug Administration in reviewing the 
petition referred to in paragraph (1) and the reasons action on 
the petition was delayed. 
SEC. 308. GLASS AND CERAMIC WARE. 
21 USC 348 note. 
(a) IN GENERAL.—^The Secretary may not implement any 
requirement which would ban, as an unapproved food additive, 
lead and cadmium based enamel in the lip and rim area of glass 
and ceramic ware before the expiration of one year after the date 
such requirement is published. 
(b) LEAD AND CADMIUM BASED ENAMEL.—Unless the Secretary 
determines, based on available data, that lead and cadmium based 
enamel on glass and ceramic ware— 
(1) which has less than 60 millimeters of decorating area 
below the external rim, and 
(2) which is not, by design, representation, or custom of 
usage intended for use by children. 
I l l STAT. 2354 
PUBLIC LAW 105-115—NOV. 21, 1997 
is unsafe, the Secretary shall not take any action before January 
1, 2003, to ban lead and cadmium based enamel on such glass 
and ceramic ware. Any action taken after January 1, 2003, to 
ban such enamel on such glass and ceramic ware as an unapproved 
food additive shall be taken by regulation and such regulation 
shall provide that such products shall not be removed from the 
market before 1 year after publication of the final regulation. 
SEC. 309. FOOD CONTACT SUBSTANCES. 
(a) FOOD CONTACT SUBSTANCES.—Section 409(a) (21 U.S.C. 
348(a)) is amended— 
(1) in paragraph (1)— 
(A) by striking "subsection (i)" and inserting "sub-
section (j)"; and 
(B) by striking at the end "or"; 
(2) by striking the period at the end of paragraph (2) 
and inserting "; or"; 
(3) by inserting after paragraph (2) the following: 
"(3) in the case of a food additive as defined in this Act 
that is a food contact substance, there is— 
"(A) in effect, and such substance and the use of such 
substance are in conformity with, a regulation issued under 
this section prescribing the conditions under which such 
additive may be safely used; or 
"(B) a notification submitted under subsection (h) that 
is effective."; and 
(4) by striking the matter following paragraph (3) (as added 
by paragraph (3)) and inserting the following flush sentence: 
"While such a regulation relating to a food additive, or such a 
notification under subsection (h)(1) relating to a food additive that 
is a food contact substance, is in effect, and has not been revoked 
pursuant to subsection (i), a food shall not, by reason of bearing 
or containing such a food additive in accordance with the regulation 
or notification, be considered adulterated under section 402(a)(1).". 
(b) NOTIFICATION FOR FOOD CONTACT SUBSTANCES.—Section 
409 (21 U.S.C. 348), as amended by subsection (a), is further amend-
ed— 
(1) by redesignating subsections (h) and (i), as subsections 
(i) and 0), respectively; 
(2) by inserting after subsection (g) the following: 
"Notification Relating to a Food Contact Substance 
"(h)(1) Subject to such regulations as may be promulgated 
under paragraph (3), a manufacturer or supplier of a food contact 
substance may, at least 120 days prior to the introduction or deliv-
ery for introduction into interstate commerce of the food contact 
substance, notify the Secretary of the identity and intended use 
of the food contact substance, and of the determination of the 
manufacturer or supplier that the intended use of such food contact 
substance is safe under the standard described in subsection 
(c)(3)(A). The notification shall contain the information that forms 
the basis of the determination and all information required to 
be submitted by regulations promulgated by the Secretary. 
"(2)(A) A notification submitted under paragraph (1) shall 
become effective 120 days after the date of receipt by the Secretary 
and the food contact substance may be introduced or delivered 
for introduction into interstate commerce, unless the Secretary 
I^fefij^--
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2355 
makes a determination within the 120-day period that, based on 
the data and information before the Secretary, such use of the 
food contact substance has not been shown to be S£ife under the 
standard described in subsection (c)(3)(A), and informs the manufac-
turer or supplier of such determination. 
"(B) A decision by the Secretary to object to a notification 
shall constitute final agency action subject to judicial review. 
"(C) In this paragraph, the term 'food contact substance' means 
the substance that is the subject of a notification submitted under 
paragraph (1), and does not include a similar or identical substance 
manufactured or prepared by a person other than the manufacturer 
identified in the notification. 
"(3)(A) The process in this subsection shall be utilized for 
authorizing the marketing of a food contact substance except where 
the Secretary determines that submission and review of a petition 
under subsection (b) is necessary to provide adequate assurance 
of safety, or where the Secretary and any manufacturer or supplier 
agree that such manufacturer or supplier may submit a petition 
under subsection (b). 
"(B) The Secretary is authorized to promulgate regulations 
to identify the circumstances in which a petition shall be filed 
under subsection (b), and shall consider criteria such as the probable 
consumption of such food contact substance and potential toxicity 
of the food contact substance in determining the circumstances 
in which a petition shall be filed under subsection (b). 
"(4) The Secretary shall keep confidential any information pro-
vided in a notification under paragraph (1) for 120 days after 
receipt by the Secretary of the notification. After the expiration 
of such 120 days, the information shall be available to any 
interested party except for any matter in the notification that 
is a trade secret or confidential commercial information. 
"(5)(A)(i) Except as provided in clause (ii), the notification pro-
gram established under this subsection shall not operate in any 
fiscal year unless— 
"(I) an appropriation equal to or exceeding the applicable 
amount under clause (iv) is made for such fiscal year for carry-
ing out such program in such fiscal year; and 
"(II) the Secretary certifies that the amount appropriated 
for such fiscal year for the Center for Food Safety and Applied 
Nutrition of the Food and Drug Administration (exclusive of 
the appropriation referred to in subclause (I)) equals or exceeds 
the amount appropriated for the Center for fiscal year 1997, 
excluding any amount appropriated for new programs, 
"(ii) The Secretary shall, not later than April 1, 1999, begin 
accepting and reviewing notifications submitted under the notifica-
tion program established under this subsection if— 
"(I) an appropriation equal to or exceeding the applicable 
amount under clause (iii) is made for the last six months 
of fiscal year 1999 for carrying out such program during such 
period; and 
"(II) the Secretary certifies that the amount appropriated 
for such period for the Center for Food Safety and Applied 
Nutrition of the Food and Drug Administration (exclusive of 
the appropriation referred to in subclause (I)) equals or exceeds 
an amount equivalent to one-half the amount appropriated 
for the Center for fiscEil year 1997, excluding any amount 
appropriated for new programs. 
I l l STAT. 2356 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(iii) For the last six months of fiscal year 1999, the applicable 
amount under this clause is $1,500,000, or the amount specified 
in the budget request of the President for the six-month period 
involved for carrying out the notification program in fiscal year 
1999, whichever is less. 
"(iv) For fiscal year 2000 and subsequent fiscal years, the 
applicable amount under this clause is $3,000,000, or the amount 
specified in the budget request of the President for the fiscal year 
involved for carrying out the notification program under this sub-
section, whichever is less. 
"(B) For purposes of canying out the notification program under 
this subsection, there are authorized to be appropriated such sums 
as may be necessary for each of the fiscal years 1999 through 
fiscal year 2003, except that such authorization of appropriations 
is not effective for a fiscal year for any amount that is less than 
the applicable amount under clause (iii) or (iv) of subparagraph 
(A), whichever is applicable. 
"(C) Not later than April 1 of fiscal year 1998 and February 
1 of each subsequent fiscal year, the Secretary shall submit a 
report to the Committees on Appropriations of the House of Rep-
resentatives and the Senate, the Committee on Commerce of the 
House of Representatives, and the Committee on Labor and Human 
Resources of the Senate that provides an estimate of the Secretary 
of the costs of carrying out the notification program established 
under this subsection for the next fiscal year. 
"(6) In this section, the term 'food contact substance' means 
any substance intended for use as a component of materials used 
in manufacturing, packing, packaging, transporting, or holding food 
if such use is not intended to have any technical effect in such 
food."; 
(3) in subsection (i), as so redesignated by paragraph (1), 
by adding at the end the following: "The Secretary shall by 
regulation prescribe the procedure by which the Secretary may 
deem a notification under subsection (h) to no longer be effec-
tive."; and 
(4) in subsection (j), as so redesignated by paragraph (1), 
by striking "subsections (b) to (h)" and inserting "subsections 
(b)to(i)". 
TITLE IV—GENERAL PROVISIONS 
SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES. 
(a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) is amended 
by inserting after subchapter C the following: 
"SUBCHAPTER D—DISSEMINATION OF TREATMENT INFORMATION 
21USC360AAA. 
"SEC. 551. REQUIREMENTS FOR DISSEMINATION OF TREATMENT 
INFORMATION ON DRUGS OR DEVICES. 
"(a) IN GENERAL.—^Notwithstanding sections 301(d), 502(f), and 
505, and section 351 of the PubHc Health Service Act (42 U.S.C. 
262), a manufacturer may disseminate to— 
"(1) a health care practitioner; 
"(2) a pharmacy benefit manager; 
"(3) a health insureuice issuer; 
"(4) a group health plan; or 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2357 
"(5) a Federal or State governmental agency; 
written information concerning the safety, effectiveness, or benefit 
of a use not described in the approved labeling of a drug or device 
if the manufacturer meets the requirements of subsection (b). 
"(b) SPECIFIC REQUIREMENTS.—^A manufacturer may dissemi-
nate information under subsection (a) on a new use only if— 
"(1)(A) in the case of a drug, there is in effect for the 
drug an application filed under subsection (b) or (j) of section 
505 or a biologies license issued under section 351 of the Public 
Health Service Act; or 
"(B) in the case of a device, the device is being commercially 
distributed in accordance with a regulation under subsection 
(d) or (e) of section 513, an order under subsection (f) of such 
section, or the approval of an application under section 515; 
"(2) the information meets the requirements of section 552; 
"(3) the information to be disseminated is not derived from 
clinical research conducted by another manufacturer or if it 
was derived fi*om research conducted by another msmufacturer, 
the manufacturer disseminating the information has the 
permission of such other manufacturer to make the dissemina-
tion; 
"(4) the manufacturer has, 60 days before such dissemina-
tion, submitted to the Secretary— 
"(A) a copy of the information to be disseminated; 
and 
"(B) any clinical trial information the manufacturer 
has relating to the safety or effectiveness of the new use, 
any reports of clinical experience pertinent to the safety 
of the new use, and a summary of such information; 
"(5) the manufacturer has complied with the requirements 
of section 554 (relating to a supplemental application for such 
use); 
"(6) the manufacturer includes along with the information 
to be disseminated under this subsection— 
"(A) a prominently displayed statement that discloses— 
"(i) that the information concerns a use of a drug 
or device that has not been approved or cleared by 
the Food and Drug Administration; 
"(ii) if applicable, that the information is being 
disseminated at the expense of the manufacturer; 
"(iii) if applicable, the name of any authors of 
the information who are employees of, consultants to, 
or have received compensation from, the manufacturer, 
or who have a significant financial interest in the 
manufacturer; 
"(iv) the official labeling for the drug or device 
and all updates with respect to the labeling; 
"(v) if applicable, a statement that there are prod-
ucts or treatments that have been approved or cleared 
for the use that is the subject of the information being 
disseminated pursuant to subsection (a)(1); and 
"(vi) the identification of any person that has pro-
vided funding for the conduct of a study relating to 
the new use of a drug or device for which such informa-
tion is being disseminated; and 
"(B) a bibliography of other articles from a scientific 
reference publication or scientific or medical journal that 
I l l STAT. 2358 
PUBLIC LAW 105-115—NOV. 21, 1997 
have been previously published about the use of the drug 
or device covered by the information disseminated (unless 
the information already includes such bibliography). 
"(c) ADDITIONAL INFORMATION.—If the Secretary determines, 
after providing notice of such determination and an opportunity 
for a meeting with respect to such determination, that the informa-
tion submitted by a manufacturer under subsection (b)(3)(B), with 
respect to the use of a drug or device for which the manufacturer 
intends to disseminate information, fails to provide data, analyses, 
or other written matter that is objective and balanced, the Secretary 
may require the manufacturer to disseminate— 
"(1) additional objective and scientifically soxmd informa-
tion that pertains to the safety or effectiveness of the use 
and is necessary to provide objectivity and balance, including 
any information that the manufacturer has submitted to the 
Secretary or, where appropriate, a summary of such information 
or any other information that the Secretary has authority to 
make available to the public; and 
"(2) an objective statement of the Secretary, based on data 
or other scientifically sound information available to the Sec-
retary, that bears on the safety or effectiveness of the new 
use of the drug or device. 
21 use 
"SEC. 552. INFORMATION AUTHORIZED TO BE DISSEMINATED. 
"(a) AUTHORIZED INFORMATION,—^A manufacturer may dissemi-
nate information under section 551 on a new use only if the informa-
tion— 
"(1) is in the form of an unabridged— 
"(A) reprint or copy of an article, peer-reviewed by 
experts qualified by scientific training or experience to 
evaluate the safety or effectiveness of the drug or device 
involved, which was published in a scientific or medical 
journal (as defined in section 556(5)), which is about a 
clinical investigation with respect to the drug or device, 
and which would be considered to be scientifically sound 
by such experts; or 
"(B) reference publication, described in subsection (b), 
that includes information about a clinical investigation with 
respect to the drug or device that would be considered 
to be scientifically sound by experts qualified by scientific 
training or experience to evaluate the safety or effectiveness 
of the drug or device that is the subject of such a clinical 
investigation; and 
"(2) is not false or misleading and would not pose a signifi-
cant risk to the public health. 
"(b) REFERENCE PUBLICATION.—A reference publication referred 
to in subsection (a)(1)(B) is a publication that— 
"(1) has not been written, edited, excerpted, or published 
specifically for, or at the request of, a msinufacturer of a drug 
or device; 
"(2) has not been edited or significantly influenced by such 
a manufacturer; 
"(3) is not solely distributed through such a manufacturer 
but is generally available in bookstores or other distribution 
channels where medical textbooks are sold; 
"(4) does not focus on any particular drug or device of 
a manufacturer that disseminates information under section 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2359 
551 and does not have a primary focus on new uses of drugs 
or devices that are marketed or under investigation by a manu-
facturer supporting the dissemination of information; and 
"(5) presents materials that are not false or misleading. 
"SEC. 553. ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICA-
TIONS DISSEMINATED AND LIST OF PROVIDERS THAT 
RECEIVED ARTICLES AND REFERENCE PUBLICATIONS. 
"(a) IN GENERAL.—^A manufacturer may disseminate informa-
tion under section 551 on a new use only if the manufacturer 
prepares and submits to the Secretary biannually— 
"(1) a list containing the titles of the articles and reference 
publications relating to the new use of drugs or devices that 
were disseminated by the manufacturer to a person described 
in section 551(a) for the 6-month period preceding the date 
on which the manufacturer submits the list to the Secretary; 
and 
"(2) a list that identifies the categories of providers (as 
described in section 551(a)) that received the articles and ref-
erence publications for the 6-month period described in para-
graph (1). 
"(b) RECORDS.—A manufacturer that disseminates information 
under section 551 shall keep records that may be used by the 
manufacturer when, pursuant to section 555, such manufacturer 
is required to take corrective action and shall be made available 
to the Secretary, upon request, for purposes of ensuring or taking 
corrective action pursuant to such section. Such records, at the 
Secretary's discretion, may identify the recipient of information 
provided pursuant to section 551 or the categories of such recipients. 
"SEC. 554. REQUIREMENT 
REGARDING 
SUBMISSION 
OF 
SUPPLE-
MENTAL APPLICATION FOR NEW USE; EXEMPTION FROM 
REQUIREMENT. 
"(a) IN GENERAL.—^A manufacturer may disseminate informa-
tion under section 551 on a new use only if— 
"(1)(A) the manufacturer has submitted to the Secretary 
a supplemental application for such use; or 
"(B) the manufacturer meets the condition described in 
subsection (b) or (c) (relating to a certification that the manufac-
turer will submit such an application); or 
"(2) there is in effect for the manufacturer an exemption 
under subsection (d) from the requirement of paragraph (1). 
"(b) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION 
IN CASE OF COMPLETED STUDIES.—For purposes of subsection 
(a)(1)(B), a manufacturer may disseminate information on a new 
use if the manufacturer has submitted to the Secretary an applica-
tion containing a certification that— 
"(1) the studies needed for the submission of a supple-
mental application for the new use have been completed; and 
"(2) the supplemental application will be submitted to the 
Secretary not later than 6 months after the date of the initial 
dissemination of information under section 551. 
"(c) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION 
IN CASE OF PLANNED STUDIES.— 
"(1) IN GENERAL.—For purposes of subsection (a)(1)(B), a 
manufacturer may disseminate information on a new use if— 
"(A) the manufacturer has submitted to the Secretary 
an application containing— 
21 use 
360aaa-2. 
21 use 
360aaa-3. 
I l l STAT. 2360 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(i) a proposed protocol and schedule for conducting 
the studies needed for the submission of a supple-
mental application for the new use; and 
"(ii) a certification that the supplemental applica-
tion will be submitted to the Secretary not later than 
36 months after the date of the initial dissemination 
of information under section 551 (or, as applicable, 
not later than such date as the Secretary may specify 
pursuant to an extension under paragraph (3)); and 
"(B) the Secretary has determined that the proposed 
protocol is adequate and that the schedule for completing 
such studies is reasonable. 
"(2) PROGRESS REPORTS ON STUDIES.—A manufacturer that 
submits to the Secretary an application under paragraph (1) 
shall submit to the Secretary periodic reports describing the 
status of the studies involved. 
"(3) EXTENSION OF TIME REGARDING PLANNED STUDIES.— 
The period of 36 months authorized in paragraph (l)(A)(ii) 
for the completion of studies may be extended by the Secretary 
if— 
"(A) the Secretary determines that the studies needed 
to submit such an application cannot be completed and 
submitted within 36 months; or 
"(B) the manufacturer involved submits to the Sec-
retary a written request for the extension and the Secretary 
determines that the manufacturer has acted with due dili-
gence to conduct the studies in a timely manner, except 
that an extension under this subparagraph may not be 
provided for more than 24 additional months. 
"(d) 
EXEMPTION 
FROM 
REQUIREMENT 
OF 
SUPPLEMENTAL 
APPLICATION.— 
"(1) IN GENERAL.—For purposes of subsection (a)(2), a 
manufacturer may disseminate information on a new use if— 
"(A) the manufacturer has submitted to the Secretary 
an application for an exemption from meeting the require-
ment of subsection (a)(1); and 
"(B)(i) the Secretary has approved the application in 
accordance with paragraph (2); or 
"(ii) the application is deemed under paragraph (3)(A) 
to have been approved (unless such approval is terminated 
pursuant to paragraph (3)(B)). 
"(2) 
CONDITIONS 
FOR APPROVAL.—The Secretary 
may 
approve an application under paragraph (1) for an exemption 
if the Secretary makes a determination described in subpara-
graph (A) or (B), as follows: 
"(A) TTie Secretary makes a determination that, for 
reasons defined by the Secretary, it would be economically 
prohibitive with respect to such drug or device for the 
manufacturer to incur the costs necessary for the submis-
sion of a supplemental application. In making such deter-
mination, the Secretary shall consider (in addition to any 
other considerations the Secretary finds appropriate)— 
"(i) the lack of the availability under law of any 
period during which the manufacturer would have 
exclusive marketing rights with respect to the new 
use involved; and 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2361 
"(ii) the size of the population expected to benefit 
from approval of the supplemental application. 
"(B) The Secretary makes a determination that, for 
reasons defined by the Secretary, it would be unethical 
to conduct the studies necessary for the supplemental 
application. In making such determination, the Secretary 
shall consider (in addition to any other considerations the 
Secretary finds appropriate) whether the new use involved 
is the standard of medical care for a health condition. 
"(3) TIME FOR CONSIDERATION OF APPLICATION; DEEMED 
APPROVAL.— 
"(A) IN GENERAL.—The Secretary shall approve or deny 
an application under paragraph (1) for an exemption not 
later than 60 days after the receipt of the application. 
If the Secretary does not comply with the preceding sen-
tence, the application is deemed to be approved. 
"(B) TERMINATION OF DEEMED APPROVAL.—If pursuant 
to a deemed approval under subparagraph (A) a manufac-
turer disseminates written information under section 551 
on a new use, the Secretary may at any time terminate 
such approval and under section 555(b)(3) order the manu-
facturer to cease disseminating the information. 
"(e) 
REQUIREMENTS REGARDING APPLICATIONS.—^Applications 
\uider this section shall be submitted in the form £ind manner 
prescribed by the Secretary. 
21 use 
360aaa-4. 
"SEC. 555. CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION. 
"(a) 
POSTDISSEMINATION 
DATA 
REGARDING 
SAFETY 
AND 
EFFECTIVENESS.— 
"(1) CORRECTIVE ACTIONS.—With respect to data received 
by the Secretary after the dissemination of information under 
section 551 by a m£inufacturer has begun (whether received 
pursuant to paragraph (2) or otherwise), if the Secretary deter-
mines that the data indicate that the new use involved may 
not be effective or may present a significant risk to public 
health, the Secretary shall, after consultation with the manufac-
turer, take such action regarding the dissemination of the 
information as the Secretary determines to be appropriate for 
the protection of the public health, which may include ordering 
that the manufacturer cease the dissemination of the informa-
tion. 
"(2) 
RESPONSIBILITIES 
OF 
MANUFACTURERS 
TO 
SUBMIT 
DATA.—After a manufacturer disseminates information under 
section 551, the manufacturer shall submit to the Secretary 
a notification of any additional knowledge of the manufacturer 
on clinical research or other data that relate to the safety 
or effectiveness of the new use involved. If the manufacturer 
is in possession of the data, the notification shall include the 
data. The Secretary shall by regulation establish the scope Regulations. 
of the responsibilities of manufacturers under this paragraph, 
including such limits on the responsibilities as the Secretary 
determines to be appropriate. 
"(b) CESSATION OF DISSEMINATION.— 
"(1) FAILURE OF MANUFACTURER TO COMPLY WITH REQUIRE-
MENTS.—The Secretary may order a manufacturer to cease 
the dissemination of information pursuant to section 551 if 
I l l STAT. 2362 
PUBLIC LAW 105-115—NOV. 21, 1997 
the Secretary determines that the information being dissemi-
nated does not comply with the requirements estabHshed in 
this subchapter. Such an order may be issued only after the 
Secretary has provided notice to the manufacturer of the intent 
of the Secretary to issue the order and (unless paragraph 
(2)(B) applies) has provided an opportunity for a meeting with 
respect to such intent. If the failure of the manufacturer con-
stitutes a minor violation of this subchapter, the Secretary 
shall delay issuing the order and provide to the manufacturer 
an opportunity to correct the violation. 
"(2) 
SUPPLEMENTAL APPLICATIONS.—The Secretary 
may 
order a manufacturer to cease the dissemination of information 
pursuant to section 551 if— 
"(A) in the case of a manufacturer that has submitted 
a supplemental application for a new use pursuant to sec-
tion 554(a)(1), the Secretary determines that the supple-
mental application does not contain adequate information 
for approval of the new use for which the application was 
submitted; 
"(B) in the case of a manufacturer that has submitted 
a certification under section 554(b), the manufacturer has 
not, within the 6-month period involved, submitted the 
supplemental application referred to in the certification; 
or 
"(C) in the case of a manufacturer that has submitted 
a certification under section 554(c) but has not yet submit-
ted the supplemental application referred to in the certifi-
cation, the Secretary determines, after an informal hearing, 
that the manufacturer is not acting with due diligence 
to complete the studies involved. 
"(3) 
TERMINATION OF DEEMED APPROVAL OF EXEMPTION 
REGARDING SUPPLEMENTAL APPLICATIONS.—If Under 
section 
554(d)(3) the Secretary terminates a deemed approval of an 
exemption, the Secretary may order the manufacturer involved 
to cease disseminating the information. A manufacturer shall 
comply with an order under the preceding sentence not later 
than 60 days after the receipt of the order. 
"(c) CORRECTIVE ACTIONS BY MANUFACTURERS.— 
"(1) IN GENERAL.—In any case in which under this section 
the Secretary orders a manufacturer to cease disseminating 
information, the Secretary may order the manufacturer to take 
action to correct the information that has been disseminated, 
except as provided in paragraph (2). 
"(2) 
TERMINATION OF DEEMED APPROVAL OF EXEMPTION 
REGARDING SUPPLEMENTAL APPLICATIONS.—In the case of an 
order under subsection (b)(3) to cease disseminating informa-
tion, the Secretary may not order the manufacturer involved 
to take action to correct the information that has been dissemi-
nated unless the Secretary determines that the new use 
described in the information would pose a significant risk to 
the public health. 
21 use 
"SEC. 556. DEFINITIONS. 
"For purposes of this subchapter: 
"(1) The term liealth care practitioner' means a physician, 
or other individual who is a provider of health care, who is 
licensed under the law of a State to prescribe drugs or devices. 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2363 
"(2) The terms liealth insurance issuer' and 'group health 
plan' have the megining given such terms under section 2791 
of the Public Health Service Act. 
"(3) The term 'manufacturer' means a person who manufac-
tures a drag or device, or who is licensed by such person 
to distribute or market the drug or device. 
"(4) The term 'new use'— 
"(A) with respect to a drug, means a use that is not 
included in the labeling of the approved drug; and 
"(B) with respect to a device, means a use that is 
not included in the labeling for the approved or cleared 
device. 
"(5) The term 'scientific or medical journal' meems a sci-
entific or medical publication— 
"(A) that is published by an organization— 
"(i) that has an editorial board; 
"(ii) that utilizes experts, who have demonstrated 
expertise in the subject of an article under review 
by the organization and who are independent of the 
organization, to review and objectively select, reject, 
or provide comments about proposed articles; and 
"(iii) that has a publicly stated policy, to which 
the organization adheres, of full disclosure of any con-
flict of interest or biases for all authors or contributors 
involved with the journal or organization; 
"(B) whose articles are peer-reviewed and published 
in accordance with the regular peer-review procedures of 
the organization; 
"(C) that is generally recognized to be of national scope 
and reputation; 
"(D) that is indexed in the Index Medicus of the 
National Library of Medicine of the National Institutes 
of Health; and 
"(E) that is not in the form of a special supplement 
that has been funded in whole or in part by one or more 
manufacturers. 
"SEC. 557. RULES OF CONSTRUCTION. 
21USC 
360a£i8i—€ 
"(a) UNSOLICITED REQUEST.—Nothing in section 551 shall be 
construed as prohibiting a manufacturer fi*om disseminating 
information in response to an unsolicited request fi*om a health 
care practitioner. 
"(b) DISSEMINATION OF INFORMATION ON DRUGS OR DEVICES 
NOT EVIDENCE OF INTENDED USE.—Notwithstanding subsection (a), 
(f), or (o) of section 502, or £iny other provision of law, the dissemina-
tion of information relating to a new use of a drug or device, 
in accordance with section 551, shall not be construed by the 
Secretary as evidence of a new intended use of the drug or device 
that is different firom the intended use of the drug or device set 
forth in the official labeling of the drug or device. Such dissemina-
tion shall not be considered by the Secretary as labeling, adultera-
tion, or misbranding of the drug or device. 
"(c) PATENT PROTECTION.—Nothing in section 551 shall affect 
patent rights in any manner. 
"(d) AUTHORIZATION FOR DISSEMINATION OF ARTICLES AND FEES 
FOR REPRINTS OF ARTICLES.—^Nothing in section 551 shall be con-
strued as prohibiting an entity that publishes a scientific journal 
I l l STAT. 2364 
PUBLIC LAW 105-115—NOV. 21, 1997 
21 u s e 360aaa 
note. 
21 u s e 360aaa 
note. 
21 u s e 360aaa 
note. 
21 u s e 360aaa 
note. 
(as defined in section 556(5)) from requiring authorization from 
the entity to disseminate an ari;icle pubhshed by such entity or 
charging fees for the purchase of reprints of pubhshed articles 
from such entity.". 
(b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), as amended 
by section 210, is amended by adding at the end the following: 
"(z) The dissemination of information in violation of section 
551.". 
(c) REGULATIONS.—Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services 
shall promulgate regulations to implement the amendments made 
by this section. 
(d) EFFECTIVE DATE.—^The amendments made by this section 
shall take effect 1 year after the date of enactment of this Act, 
or upon the Secretary's issuance of final regulations pursuant to 
subsection (c), whichever is sooner. 
(e) SUNSET.—The amendments made by this section cease to 
be effective September 30, 2006, or 7 years after the date on 
which the Secretary promulgates the regulations described in sub-
section (c), whichever is later. 
(f) STUDIES AND REPORTS.— 
(1) GENERAL ACCOUNTING OFFICE.— 
(A) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to determine the 
impact of subchapter D of chapter V of the Federal Food, 
Drug, and Cosmetic Act, as added by this section, on the 
resources of the Department of Health and Human Serv-
ices. 
(B) REPORT.—Not later than January 1, 2002, the 
Comptroller General of the United States shall prepare 
and submit to the Committee on Labor and Human 
Resources of the Senate and the Committee on Commerce 
of the House of Representatives a report of the results 
of the study. 
(2) DEPARTMENT OF HEALTH AND HUMAN SERVICES.— 
(A) IN GENERAL.—In order to assist Congress in deter-
mining whether the provisions of such subchapter should 
be extended beyond the termination date specified in sub-
section (e), the Secretary of Health and Human Services 
shall, in accordance with subparagraph (B), arrange for 
the conduct of a study of the scientific issues raised as 
a result of the enactment of such subchapter including 
issues relating to— 
(i) the effectiveness of such subchapter with respect 
to the provision of useful scientific information to 
health care practitioners; 
(ii) the quality of the information being dissemi-
nated pursuant to the provisions of such subchapter; 
(iii) the quality and usefulness of the information 
provided, in accordance with such subchapter, by the 
Secretary or by the manufacturer at the request of 
the Secretary; and 
(iv) the impact of such subchapter on research 
in the area of new uses, indications, or dosages, 
particularly the impact on pediatric indications and 
rare diseases. 
(3) PROCEDURE FOR STUDY.— 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2365 
(A) IN GENERAL.—The Secretary shall request the 
Institute of Medicine of the National Academy of Sciences 
to conduct the study required by paragraph (2), £ind to 
prepare and submit the report required by subparagraph 
(B), under an arrangement by which the actual expenses 
incurred by the Institute of Medicine in conducting the 
study and preparing the report will be paid by the Sec-
retary. If the Institute of Medicine is unwilling to conduct 
the study under such an arrangement, the Comptroller 
General of the United States shall conduct such study. 
(B) REPORT.—Not later than September 30, 2005, the 
Institute of Medicine or the Comptroller General of the 
United States, as appropriate, shall prepare and submit 
to the Committee on Labor and Human Resources of the 
Senate, the Committee on Commerce of the House of Rep-
resentatives, and the Secretary a report of the results 
of the study required by paragraph (2). The Secretary, 
after the receipt of the report, shall make the report avail-
able to the public. 
SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND 
DIAGNOSTICS. 
Chapter V (21 U.S.C. 351 et seq.), as amended in section 
401, is further amended by adding at the end the following: 
"SUBCHAPTER E—GENERAL PROVISIONS RELATING TO DRUGS AND 
DEVICES 
"SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND 
21USC 360BBB. 
DIAGNOSTICS. 
"(a) EMERGENCY SITUATIONS.—The Secretary may, under appro-
priate conditions determined by the Secretary, authorize the ship-
ment of investigational drugs or investigational devices for the 
diagnosis, monitoring, or treatment of a serious disease or condition 
in emergency situations. 
"(b) 
INDIVIDUAL PATIENT ACCESS TO INVESTIGATIONAL PROD-
UCTS 
INTENDED FOR 
SERIOUS DISEASES.—Any person, acting 
through a physician licensed in accordance with State law, may 
request from a manufacturer or distributor, and any manufacturer 
or distributor may, after compl3dng with the provisions of this 
subsection, provide to such physician an investigational drug or 
investigational device for the diagnosis, monitoring, or treatment 
of a serious disease or condition if— 
"(1) the licensed physician determines that the person has 
no comparable or satisfactory alternative therapy available to 
diagnose, monitor, or treat the disease or condition involved, 
and that the probable risk to the person from the investigational 
drug or investigational device is not greater than the probable 
risk from the disease or condition; 
"(2) the Secretary determines that there is sufficient evi-
dence of safety and effectiveness to support the use of the 
investigational drug or investigational device in the case 
described in paragraph (1); 
"(3) the Secretary determines that provision of the inves-
tigational drug or investigational device will not interfere with 
the initiation, conduct, or completion of clinical investigations 
to support marketing approval; and 
Ill STAT. 2366 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(4) the sponsor, or clinical investigator, of the investiga-
tional drug or investigational device submits to the Secretary 
a clinical protocol consistent with the provisions of section 
505(i) or 520(g), including any regulations promulgated under 
section 505(i) or 520(g), describing the use of the investigational 
drug or investigational device in a single patient or a small 
group of patients. 
"(c) TREATMENT INVESTIGATIONAL NEW DRUG APPLICATIONS AND 
TREATMENT INVESTIGATIONAL DEVICE EXEMPTIONS.—Upon submis-
sion by a sponsor or a physician of a protocol intended to provide 
widespread access to an investigational drug or investigational 
device for eligible patients (referred to in this subsection as an 
'expanded access protocol'), the Secretary shall permit such inves-
tigational drug or investigational device to be made available for 
expanded access under a treatment investigational new drug 
application or treatment investigational device exemption if the 
Secretary determines that— 
"(1) under the treatment investigational new drug applica-
tion or treatment investigational device exemption, the inves-
tigational drug or investigational device is intended for use 
in the diagnosis, monitoring, or treatment of a serious or imme-
diately life-threatening disease or condition; 
"(2) there is no comparable or satisfactory alternative ther-
apy available to diagnose, monitor, or treat that stage of disease 
or condition in the population of patients to which the investiga-
tional drug or investigational device is intended to be adminis-
tered; 
"(3)(A) the investigational drug or investigational device 
is under investigation in a controlled cUnical trial for the use 
described in paragraph (1) under an investigational drug 
application in effect imder section 505(i) or investigational 
device exemption in effect under section 520(g); or 
"(B) all clinical trials necessary for approval of that use 
of the investigational drug or investigational device have been 
completed; 
"(4) the sponsor of the controlled clinical trials is actively 
pursuing marketing approval of the investigational drug or 
investigational device for the use described in paragraph (1) 
with due diligence; 
"(5) in the case of an investigational drug or investigational 
device described in paragraph (3)(A), the provision of the inves-
tigational drug or investigational device will not interfere with 
the enrollment of patients in ongoing clinical investigations 
under section 505(i) or 520(g); 
"(6) in the case of serious diseases, there is sufficient evi-
dence of safety and effectiveness to support the use described 
in paragraph (1); and 
"(7) in the case of immediately life-threatening diseases, 
the available scientific evidence, taken as a whole, provides 
a reasonable basis to conclude that the investigational drug 
or investigational device may be effective for its intended use 
and would not expose patients to an unreasonable and signifi-
cant risk of illness or injury. 
A protocol submitted under this subsection shall be subject to 
the provisions of section 505(i) or 520(g), including regulations 
promulgated under section 505(i) or 520(g). The Secretary may 
inform national, State, and local medical associations and societies, 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2367 
voluntary health associations, and other appropriate persons about 
the availability of an investigational drug or investigational device 
under expanded access protocols submitted under this subsection. 
The information provided by the Secretary, in accordance with 
the preceding sentence, shall be the same type of information that 
is required by section 402(j)(3) of the Public Health Service Act. 
"(d) TERMINATION.—The Secretary may, at any time, with 
respect to a sponsor, physician, manufacturer, or distributor 
described in this section, terminate expanded access provided under 
this section for an investigational drug or investigational device 
if the requirements under this section are no longer met. 
"(e) DEFINITIONS.—In this section, the terms 'investigational 
drug*, 'investigational device', 'treatment investigational new drug 
application', and 'treatment investigational device exemption' shall 
have the meanings given the terms in regulations prescribed by 
the Secretary.". 
SEC. 403. APPROVAL 
OF 
SUPPLEMENTAL 
APPLICATIONS 
FOR 
21USC 371 note. 
APPROVED PRODUCTS. 
(a) STANDARDS.—Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services 
shall publish in the Federal Register standards for the prompt 
review of supplemental applications submitted for approved articles 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 
262). 
(b) GUIDANCE TO INDUSTRY.—Not later than 180 days after 
the date of enactment of this Act, the Secretary shall issue final 
guidances to clarify the requirements for, and facilitate the submis-
sion of data to support, the approval of supplemental applications 
for the approved articles described in subsection (a). The guidances 
shall— 
(1) clarify circumstances in which published matter may 
be the basis for approval of a supplemental application; 
(2) specify data requirements that will avoid duplication 
of previously submitted data by recognizing the availability 
of data previously submitted in support of an original applica-
tion; and 
(3) define supplemental applications that are eligible for 
priority review. 
(c) RESPONSIBILITIES OF CENTERS.—The Secretary shall des-
ignate an individual in each center within the Food and Drug 
Administration (except the Center for Food Safety and Applied 
Nutrition) to be responsible for— 
(1) encouraging the prompt review of supplemental applica-
tions for approved articles; and 
(2) working with sponsors to facilitate the development 
£ind submission of data to support supplemental applications. 
(d) COLLABORATION.—The Secretary shall implement programs 
and policies that will foster collaboration between the Food and 
Drug Administration, the National Institutes of Health, professional 
medical and scientific societies, and other persons, to identify pub-
lished and unpublished studies that may support a supplemental 
application, and to encourage sponsors to make supplemental 
applications or conduct further research in support of a supple-
mental application based, in whole or in part, on such studies. 
I l l STAT. 2368 
PUBLIC LAW 105-115—NOV. 21, 1997 
21 use 
360bbb-l. 
Regulations. 
SEC. 404. DISPUTE RESOLUTION. 
Subchapter E of chapter V, as added by section 402, is amended 
by adding at the end the following: 
"SEC. 562. DISPUTE RESOLUTION. 
"If, regarding an obligation concerning drugs or devices under 
this Act or section 351 of the Public Health Service Act, there 
is a scientific controversy between the Secretary and a person 
who is a sponsor, applicant, or manufacturer and no specific provi-
sion of the Act involved, including a regulation promulgated under 
such Act, provides a right of review of the matter in controversy, 
the Secretary shall, by regulation, establish a procedure under 
which such sponsor, applicant, or manufacturer may request a 
review of such controversy, including a review by an appropriate 
scientific advisory panel described in section 505(n) or an advisory 
committee described in section 515(g)(2)(B). Any such review shall 
take place in a timely manner. The Secretary shall promulgate 
such regulations within 1 year after the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997.". 
SEC. 
405. 
INFORMAL 
AGENCY 
STATEMENTS. 
Section 701 (21 U.S.C. 371) is amended by adding at the end 
the following: 
"(h)(1)(A) The Secretary shall develop guidance documents with 
public participation and ensure that information identifying the 
existence of such documents and the documents themselves are 
made available to the public both in written form and, as feasible, 
through electronic means. Such documents shall not create or confer 
any rights for or on any person, although they present the views 
of the Secretary on matters under the jurisdiction of the Food 
and Drug Administration. 
"(B) Although guidance documents shall not be binding on 
the Secretary, the Secretary shall ensure that employees of the 
Food and Drug Administration do not deviate from such guidances 
without appropriate justification and supervisory concurrence. The 
Secretary shall provide training to employees in how to develop 
and use guidance documents and shall monitor the development 
and issuance of such documents. 
"(C) For guidance documents that set forth initial interpreta-
tions of a statute or regulation, changes in interpretation or policy 
that are of more than a minor nature, complex scientific issues, 
or highly controversial issues, the Secretary shall ensure public 
participation prior to implementation of guidance documents, unless 
the Secretary determines that such prior public participation is 
not feasible or appropriate. In such cases, the Secretary shall pro-
vide for public comment upon implementation and take such com-
ment into account. 
"(D) For guidance documents that set forth existing practices 
or minor changes in policy, the Secretary shall provide for public 
comment upon implementation. 
"(2) In developing guideince documents, the Secretary shall 
ensure uniform nomenclature for such documents and uniform 
internal procedures for approval of such documents. The Secretary 
shall ensure that guidance documents and revisions of such docu-
ments are properly dated and indicate the nonbinding nature of 
the documents. The Secretary shall periodically review all guidsmce 
documents and, where appropriate, revise such documents. 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2369 
"(3) The Secretary, acting through the Commissioner, shall 
maintain electronically and update and publish periodically in the 
Federal Register a list of guidance documents. All such documents 
shall be made available to the public. 
"(4) The Secretary shall ensure that an effective appeals mecha-
nism is in place to address complaints that the Food and Drug 
Administration is not developing and using guidance documents 
in accordance with this subsection. 
"(5) Not later than July 1, 2000, the Secretary after evaluating Regulations, 
the effectiveness of the Good Guidance Practices document, pub-
lished in the Federal Register at 62 Fed. Reg. 8961, shall promul-
gate a regulation consistent with this subsection specifying the 
policies and procedures of the Food and Drug Administration for 
the development, issuance, and use of guidcmce documents.". 
SEC. 406. FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL 
REPORT. 
(a) MISSION.—Section 903 (21 U.S.C. 393) is amended— 
(1) by redesignating subsections (b) and (c) as subsections 
(d) and (e), respectively; and 
(2) by inserting after subsection (a) the following: 
"(b) MISSION.—The Administration shall— 
"(1) promote the public health by promptly and efficiently 
reviewing clinical research and taking appropriate action on 
the marketing of regulated products in a timely manner; 
"(2) with respect to such products, protect the public health 
by ensuring that— 
"(A) foods Eire safe, wholesome, sanitary, and properly 
labeled; 
"(B) human and veterinary drugs are safe and effective; 
"(C) there is reasonable assurance of the safety and 
effectiveness of devices intended for human use; 
"(D) cosmetics are safe and properly labeled; and 
"(E) public health and safety are protected from elec-
tronic product radiation; 
"(3) participate through appropriate processes with rep-
resentatives of other countries to reduce the burden of regula-
tion, harmonize regulatory requirements, and achieve appro-
priate reciprocal arrangements; and 
"(4) as determined to be appropriate by the Secretary, 
carry out paragraphs (1) through (3) in consultation with 
experts in science, medicine, and public health, and in coopera-
tion with consumers, users, manufacturers, importers, packers, 
distributors, and retailers of regulated products.". 
(b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393), as amended 
by subsection (a), is further amended by adding at the end the 
following: 
"(f) AGENCY PLAN FOR STATUTORY COMPLIANCE.— 
"(1) IN GENERAL.—Not later than 1 year after the date 
Federal Register, 
of enactment of the Food and Drug Administration Modemiza- publication. 
tion Act of 1997, the Secretary, after consultation with appro-
priate scientific and academic experts, health care professionals, 
representatives of patient and consumer advocacy groups, and 
the regulated industry, shall develop and publish in the Federal 
Register a plan bringing the Secretary into compliance with 
each of the obligations of the Secretary under this Act. The 
I l l STAT. 2370 
PUBLIC LAW 105-115—NOV. 21, 1997 
Secretary shall review the plan biannually and shall revise 
the plan as necessary, in consultation with such persons. 
"(2) OBJECTIVES OF AGENCY PLAN.—The plan required by 
paragraph (1) shall establish objectives and mechanisms to 
achieve such objectives, including objectives related to— 
"(A) maximizing the availability and clarity of informa-
tion about the process for review of applications and 
submissions (including petitions, notifications, and any 
other similar forms of request) made under this Act; 
"(B) maximizing the availability and clarity of informa-
tion for consumers and patients concerning new products; 
"(C) implementing inspection and postmarket monitor-
ing provisions of this Act; 
"(D) ensuring access to the scientific and technical 
expertise needed by the Secretary to meet obligations 
described in paragraph (1); 
"(E) establishing mechanisms, by July 1, 1999, for 
meeting the time periods specified in this Act for the review 
of all applications and submissions described in subpara-
graph (A) and submitted after the date of enactment of 
the Food and Drug Administration Modernization Act of 
1997; and 
"(F) eliminating backlogs in the review of applications 
and submissions described in subparagraph (A), by January 
1, 2000. 
Federal Register, 
"(g) ANNUAL REPORT.—The Secretary shall annually prepare 
publication. 
and publish in the Federal Register and solicit public comment 
on a report that— 
"(1) provides detailed statistical information 
on 
the 
performance of the Secretary under the plan described in sub-
section (f); 
"(2) compares such performance of the Secretary with the 
objectives of the plan and with the statutory obligations of 
the Secretary; and 
"(3) identifies any regulatory policy that has a significant 
negative impact on compliance with any objective of the plan 
or any statutory obligation and sets forth any proposed revision 
to any such regulatory policy.". 
SEC. 407. INFORMATION SYSTEM. 
(a) AMENDMENT.—Chapter VII (21 U.S.C. 371 et seq.) is amend-
ed by adding at the end the following: 
"SUBCHAPTER D—INFORMATION AND EDUCATION 
21 use 379k. 
"SEC. 741. INFORMATION SYSTEM. 
"The Secretary shall establish and maintain an information 
system to track the status and progress of each application or 
submission (including a petition, notification, or other similar form 
of request) submitted to the Food and Drug Administration request-
ing agency action.". 
21 use 379k 
(b) REPORT.—Not later than 1 year after the date of enactment 
note. 
of this Act, the Secretary of Health and Human Services shall 
submit a report to the Committee on Labor and Humsm Resources 
of the Senate and the Committee on Commerce of the House of 
Representatives on the status of the system to be established under 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2371 
the amendment made by subsection (a), including the projected 
costs of the system and concerns about confidentiality. 
SEC. 408. EDUCATION AND TRAB«NG. 
(a) FOOD AND DRUG ADMINISTRATION.—Chapter VII (21 U.S.C. 
371 et seq.), as amended by section 407, is further amended by 
adding at the end the following section: 
"SEC. 742. EDUCATION. 
21USC 379Z. 
"(a) IN GENERAL.—^The Secretary shall conduct training and 
education programs for the employees of the Food and Drug 
Administration relating to the regulatory responsibilities and poli-
cies established by this Act, including programs for— 
"(1) scientific training; 
"(2) training to improve the skill of officers and employees 
authorized to conduct inspections under section 704; 
"(3) training to achieve product specialization in such 
inspections; and 
"(4) training in administrative process and procedure and 
integrity issues. 
"(b) 
INTRAMURAL FELLOWSHIPS AND OTHER TRAINING PRO-
GRAMS.—^The Secretary, acting through the Commissioner, may, 
through fellowships and other training programs, conduct and sup-
port intramural research training for predoctoral and postdoctoral 
scientists and physicians.". 
(b) CENTERS FOR DISEASE CONTROL AND PREVENTION.— 
(1) IN GENERAL.—Part B of title III of the Public Health 
Service Act is amended by inserting after section 317F (42 
U.S.C. 247b-7) the following: 
"SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS. 
42 USC 247b-8. 
"The Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall establish fellowship and 
training programs to be conducted by such Centers to train individ-
uals to develop skills in epidemiology, surveillance, laboratory 
analysis, and other disease detection and prevention methods. Such 
programs shall be designed to enable health professionals and 
health personnel trained under such programs to work, after receiv-
ing such training, in local. State, national, and international efforts 
toward the prevention and control of diseases, injuries, and disabil-
ities. Such fellowships and training may be administered through 
the use of either appointment or nonappointment procedures.". 
(2) EFFECTIVE DATE.—The amendment made by this sub- 42USC247b-8 
section is deemed to have taken effect July 1, 1995. 
note. 
SEC. 409. CENTERS FOR EDUCATION AND RESEARCH ON THERA-
PEUTICS. 
Title IX of the Public Health Service Act (42 U.S.C. 299 et 
seq.) is amended by adding at the end of part A the following 
new section: 
"SEC. 905. DEMONSTRATION PROGRAM REGARDING CENTERS FOR 
42 USC 299a-3. 
EDUCATION AND RESEARCH ON THERAPEUTICS. 
"(a) IN GENERAL.—^The Secretary, acting through the Adminis-
trator and in consultation with the Commissioner of Food £ind 
Drugs, shall establish a demonstration program for the purpose 
of making one or more grants for the establishment and operation 
I l l STAT. 2372 
PUBLIC LAW 105-115—NOV. 21, 1997 
of one or more centers to carry out the activities specified in 
subsection (b), 
"(b) REQUIRED ACTIVITIES.—The activities referred to in sub-
section (a) are the following: 
"(1) The conduct of state-of-the-art clinical and laboratory 
research for the following purposes: 
"(A) To increase awareness of— 
"(i) new uses of drugs, biological products, and 
devices; 
"(ii) ways to improve the effective use of drugs, 
biological products, and devices; and 
"(iii) risks of new uses and risks of combinations 
of drugs and biological products. 
"(B) To provide objective clinical information to the 
following individuals and entities: 
"(i) Health care practitioners or other providers 
of health care goods or services. 
"(ii) Pharmacy benefit managers, 
"(iii) Health maintenance organizations or other 
managed health care organizations. 
"(iv) Health care insurers or governmental agen-
cies. 
"(v) Consumers. 
"(C) To improve the quality of health care while reduc-
ing the cost of health care through— 
"(i) the appropriate use of drugs, biological prod-
ucts, or devices; and 
"(ii) the prevention of adverse effects of drugs, 
biological products, and devices and the consequences 
of such effects, such as unnecessary hospitalizations. 
"(2) The conduct of research on the comparative effective-
ness and safety of drugs, biological products, and devices. 
"(3) Such other activities as the Secretary determines to 
be appropriate, except that the grant may not be expended 
to assist the Secretary in the review of new drugs. 
"(c) APPLICATION FOR GRANT.—^A grant under subsection (a) 
may be made only if an application for the grant is submitted 
to the Secretary and the application is in such form, is made 
in such manner, £md contains such agreements, assurances, and 
information as the Secretary determines to be necessary to carry 
out this section. 
"(d) PEER REVIEW.—^A grant under subsection (a) may be made 
only if the application for the grant has undergone appropriate 
technical and scientific peer review. 
"(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$2,000,000 for fiscal year 1998, and $3,000,000 for each of fiscal 
years 1999 through 2002.". 
SEC. 410. MUTUAL 
RECOGNITION 
AGREEMENTS 
AND 
GLOBAL 
HARMONIZATION. 
(a) GOOD MANUFACTURING PRACTICE REQUIREMENTS.—Section 
520(f)(1)(B) (21 U.S.C. 360j(f)(l)(B)) is amended— 
(1) in clause (i), by striking ", and" at the end and inserting 
a semicolon; 
(2) in clause (ii), by striking the period and inserting 
"; and"; and 
«^<(fS>fr^ 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2373 
(3) by inserting after clause (ii) the following: 
"(iii) ensure that such regulation conforms, to the extent 
practicable, with internationally recognized steindgirds defining 
quality systems, or parts of the standards, for medical devices.". 
(b) HARMONIZATION EFFORTS.—Section 803 (21 U.S.C. 383) is 
amended by adding at the end the following: 
"(c)(1) The Secretary shall support the Office of the United 
States Trade Representative, in consultation with the Secretary 
of Commerce, in meetings with representatives of other countries 
to discuss methods and approaches to reduce the burden of regula-
tion and harmonize regulatory requirements if the Secretary deter-
mines that such harmonization continues consumer protections 
consistent with the purposes of this Act. 
"(2) The Secretary shall support the Office of the United States 
Trade Representative, in consultation with the Secretary of Com-
merce, in efforts to move toward the acceptance of mutual recogni-
tion agreements relating to the regulation of drugs, biological prod-
ucts, devices, foods, food additives, and color additives, and the 
regulation of good manufacturing practices, between the European 
Union and the United States. 
"(3) The Secretary shsdl regularly participate in meetings with 
representatives of other foreign governments to discuss and reach 
agreement on methods and approaches to harmonize regulatory 
requirements. 
"(4) The Secretary shall, not later than 180 days after the 
date of enactment of the Food and Drug Administration Moderniza-
tion Act of 1997, make public a plan that establishes a framework 
for achieving mutual recognition of good manufacturing practices 
inspections. 
"(5) Paragraphs (1) through (4) shall not apply with respect 
to products defined in section 201(ff).". 
SEC. 4H. ENVIRONMENTAL IMPACT REVIEW. 
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
407, is further amended by adding at the end the following: 
"SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW 
"SEC. 746. ENVIRONMENTAL IMPACT. 
21 USC 379O. 
"Notwithstanding any other provision of law, an environmental 
impact statement prepared in accordance with the regulations pub-
lished in part 25 of title 21, Code of Federal Regulations (as in 
effect on August 31, 1997) in connection with an action carried 
out under (or a recommendation or report relating to) this Act, 
shall be considered to meet the requirements for a detailed state-
ment under section 102(2)(C) of the National Environmental Policy 
Act of 1969 (42 U.S.C. 4332(2)(C)).". 
SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS 
AND COSMETICS. 
(a) NONPRESCRIPTION DRUGS.—Chapter VII (21 U.S.C. 371 et 
seq.), as amended by section 411, is further amended by adding 
at the end the following: 
I l l STAT. 2374 
PUBLIC LAW 105-115—NOV. 21, 1997 
"SUBCHAPTER 
F—NATIONAL UNIFORMITY 
FOR 
NONPRESCRIPTION 
DRUGS AND PREEMPTION FOR LABELING OR PACKAGING OF COS-
METICS 
21 USE 379R. 
"SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION 
DRUGS. 
"(a) IN GENERAL.—Except as provided in subsection (b), (c)(1), 
(d), (e), or (f), no State or political subdivision of a State may 
establish or continue in effect any requirement— 
"(1) that relates to the regulation of a drug that is not 
subject to the requirements of section 503(b)(1) or 503(f)(1)(A); 
ana 
"(2) that is different from or in addition to, or that is 
otherwise not identical with, a requirement under this Act, 
the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 
et seq,), or the Fair Packaging and Labeling Act (15 U.S.C. 
1451 et seq.). 
"(b) EXEMPTION.— 
"(1) IN GENERAL.—Upon application of a State or political 
subdivision thereof, the Secretary may by regulation, after 
notice and opportunity for written and oral presentation of 
views, exempt from subsection (a), under such conditions as 
may be prescribed in such regulation, a State or political sub-
division requirement that— 
"(A) protects an important public interest that would 
otherwise be unprotected, including the health and safety 
of children; 
"(B) would not cause any drug to be in violation of 
any applicable requirement or prohibition under Federal 
law; and 
"(C) would not imduly burden interstate commerce. 
"(2) TIMELY ACTION.—The Secretary shall make a decision 
on the exemption of a State or political subdivision requirement 
under paragraph (1) not later than 120 days after receiving 
the application of the State or political subdivision under 
paragraph (1). 
"(c) SCOPE.— 
"(1) IN GENERAL.—This section shall not apply to— 
"(A) any State or political subdivision requirement that 
relates to the practice of pharmacy; or 
"(B) any State or political subdivision requirement that 
a drug be dispensed only upon the prescription of a practi-
tioner licensed by law to administer such drug. 
"(2) SAFETY OR EFFECTIVENESS.—For purposes of subsection 
(a), a requirement that relates to the regulation of a drug 
shall be deemed to include einy requirement relating to public 
information or any other form of public communication relating 
to a warning of any kind for a drug. 
"(d) EXCEPTIONS.— 
"(1) IN GENERAL.—In the case of a drug described in sub-
section (a)(1) that is not the subject of an application approved 
under section 505 or section 507 (as in effect on the day before 
the date of enactment of the Food and Drug Administration 
Modernization Act of 1997) or a final regulation promulgated 
by the Secretary establishing conditions under which the drug 
is generally recognized as safe and effective and not mis-
branded, subsection (a) shall apply only with respect to a 
requirement of a State or political subdivision of a State that 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2375 
relates to the same subject as, but is different from or in 
addition to, or that is otherwise not identical with— 
"(A) a regulation in effect with respect to the drug 
pursuant to a statute described in subsection (a)(2); or 
"(B) any other requirement in effect with respect to 
the drug pursuant to an amendment to such a statute 
made on or after the date of enactment of the Food and 
Drug Administration Modernization Act of 1997. 
"(2) STATE INITIATIVES.—This section shall not apply to 
a State requirement adopted by a State public initiative or 
referendum enacted prior to September 1, 1997. 
"(e) No EFFECT ON PRODUCT LIABILITY LAW.—Nothing in this 
section shall be construed to modify or otherwise affect £uiy action 
or the liability of any person under the product liability law of 
any State. 
"(f) STATE ENFORCEMENT AUTHORITY.—Nothing in this section 
shall prevent a State or political subdivision thereof from enforcing, 
under any relevant civil or other enforcement authority, a require-
ment that is identical to a requirement of this Act.". 
(b) INSPECTIONS.—Section 704(a)(1) (21 U.S.C. 374(a)(1)) is 
amended by striking "prescription drugs" each place it appears 
£ind inserting "prescription drugs, nonprescription drugs intended 
for human use,". 
(c) MISBRANDING.—Subparagraph (1) of section 502(e) (21 
U.S.C. 352(e)(1)) is amended to read as follows: 
"(1)(A) If it is a drug, imless its label bears, to the exclusion 
of any other nonproprietary name (except the applicable systematic 
chemical name or the chemical formula)— 
"(i) the established name (as defined in subparagraph (3)) 
of the drug, if there is such a name; 
"(ii) the established name and quantity or, if determined 
to be appropriate by the Secretary, the proportion of each 
active ingredient, including the quantity, kind, and proportion 
of any alcohol, and also including whether active or not the 
established name and quantity or if determined to be appro-
priate by the Secretary, the proportion of any bromides, ether, 
chloroform, acetanilide, acetophenetidin, amidopyrine, anti-
P3rrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digi-
talis glucosides, mercury, ouabain, strophanthin, strychnine, 
thyroid, or any derivative or preparation of any such sub-
stances, contained therein, except that the requirement for 
stating the quantity of the active ingredients, other than the 
quantity of those specifically named in this subclause, shall 
not apply to nonprescription drugs not intended for human 
use; and 
"(iii) the established name of each inactive ingredient listed 
in alphabetical order on the outside container of the retail 
package and, if determined to be appropriate by the Secretary, 
on the immediate container, as prescribed in regulation promul-
gated by the Secretary, except that nothing in this subclause 
shall be deemed to require that any trade secret be divulged, 
and except that the requirements of this subclause with respect 
to alphabetical order shall apply only to nonprescription drugs 
that are not also cosmetics and that this subclause shall not 
apply to nonprescription drugs not intended for human use. 
"(B) For any prescription drug the established name of such 
drug or ingredient, as the case may be, on such label (and on 
I l l STAT. 2376 
PUBLIC LAW 105-115—NOV. 21, 1997 
any labeling on which a name for such drug or ingredient is used) 
shall be printed prominently and in type at least half as large 
as that used thereon for any proprietary name or designation for 
such drug or ingredient, except that to the extent that compliance 
with the requirements of subclause (ii) or (iii) of clause (A) or 
this clause is impracticable, exemptions shall be established by 
regulations promulgated by the Secretary.". 
(d) COSMETICS.—Subchapter F of chapter VTI, as amended by 
subsection (a), is further amended by adding at the end the follow-
ing: 
21 use 379s. 
"SEC. 752. PREEMPTION 
FOR 
LABELING 
OR 
PACKAGING 
OF 
COSMETICS. 
"(a) IN GENERAL.—Except as provided in subsection (b), (d), 
or (e), no State or political subdivision of a State may establish 
or continue in effect any requirement for labeling or packaging 
of a cosmetic that is different from or in addition to, or that 
is otherwise not identical with, a requirement specifically applicable 
to a particular cosmetic or class of cosmetics under this Act, the 
Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), 
or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.). 
"(b) EXEMPTION.—Upon application of a State or political sub-
division thereof, the Secretary may by regulation, after notice and 
opportunity for written and oral presentation of views, exempt 
from subsection (a), under such conditions as may be prescribed 
in such regulation, a State or political subdivision requirement 
for labeling or packaging that— 
"(1) protects an important public interest that would other-
wise be unprotected; 
"(2) would not cause a cosmetic to be in violation of any 
applicable requirement or prohibition under Federal law; and 
"(3) would not unduly burden interstate commerce. 
"(c) SCOPE.—For purposes of subsection (a), a reference to a 
State requirement that relates to the packaging or labeling of 
a cosmetic means any specific requirement relating to the same 
aspect of such cosmetic as a requirement specifically applicable 
to that particular cosmetic or class of cosmetics under this Act 
for packaging or labeling, including any State requirement relating 
to public information or any other form of public communication. 
"(d) No EFFECT ON PRODUCT LIABILITY LAW.—Nothing in this 
section shall be construed to modify or otherwise affect any action 
or the liability of any person under the product liability law of 
any State. 
"(e) STATE INITIATIVE.—This section shall not apply to a State 
requirement adopted by a State public initiative or referendum 
enacted prior to September 1,1997.". 
21 use 393 note. 
SEC. 413. FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY 
COMPOUNDS IN DRUGS AND FOOD. 
(a) LIST AND ANALYSIS.—The Secretary of Health and Human 
Services shall, acting through the Food and Drug Administration— 
(1) compile a list of drugs and foods that contain inten-
tionally introduced mercury compounds, and 
(2) provide a quantitative and qualitative analysis of the 
mercury compounds in the list under paragraph (1). 
The Secretary shall compile the list required by paragraph (1) 
within 2 years after the date of enactment of the Food and Drug 
Administration Modernization Act of 1997 and shall provide the 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2377 
analysis required by paragraph (2) within 2 years after such date 
of enactment. 
(b) STUDY.—The Secretary of Health and Human Services, act-
ing tlurough the Food £ind Drug Administration, shall conduct a 
study of the effect on humans of the use of mercury compounds 
in nasal sprays. Such study shall include data from other studies 
that have been made of such use. 
(c) STUDY OF MERCURY SALES.— 
(1) STUDY.—The Secretary of Health and Human Services, 
acting through the Food and Drug Administration and subject 
to appropriations, shall conduct, or shall contract with the 
Institute of Medicine of the National Academy of Sciences to 
conduct, a study of the effect on humans of the use of elemental, 
organic, or inorganic mercury when offered for sale as a drug 
or dietary supplement. Such study shall, among other things, 
evaluate— 
(A) the scope of mercury use as a drug or dietary 
supplement; and 
(B) the adverse effects on health of children £ind other 
sensitive copulations resulting from exposure to, or inges-
tion or iniEilation of, mercury when so used. 
In conducting 
uch study, the Secretary shall consult with 
the Administra^jr of the Environmental Protection Agency, the 
Chair of the Consumer Product Safety Commission, and the 
Administrator of the Agency for Toxic Substances and Disease 
Registry, and, to the extent the Secretary believes necessary 
or appropriate, with any other Federal or private entity. 
(2) REGULATIONS.—If, in the opinion of the Secretary, the 
use of elemental, organic, or inorganic mercury offered for 
sale as a drug or dietary supplement poses a threat to human 
health, the Secreteiry shall promulgate regulations restricting 
the sale of mercury intended for such use. At a minimum, 
such regulations shall be designed to protect the health of 
children and other sensitive populations from adverse effects 
resulting from exposure to, or ingestion or inhalation of, mer-
cury. Such regulations, to the extent feasible, should not 
unnecessarily interfere with the availability of mercury for 
use in religious ceremonies. 
SEC. 
414. 
INTERAGENCY 
COLLABORATION. 
Section 903 (21 U.S.C. 393), as amended by section 406, is 
fu..,her amended by inserting after subsection (b) the following: 
"(c) INTERAGENCY COLLABORATION.—The Secretary shall imple-
ment programs and policies that will foster collaboration between 
the Administration, the National Institutes of Health, and other 
science-based Federal agencies, to enhance the scientific and tech-
nical expertise available to the Secretary in the conduct of the 
duties of the Secretary with respect to the development, clinical 
investigation, evaluation, and postmarket monitoring of emerging 
medical 
therapies, 
including 
complementary 
therapies, 
and 
advances in nutrition and food science.". 
SEC. 415. CONTRACTS FOR EXPERT REVIEW. 
Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
214, is further amended by adding at the end the following: 
"SEC. 907. CONTRACTS FOR EXPERT REVIEW. 
21 USC 397. 
"(a) IN GENERAL.— 
3^-194 O - 97 - 10 : QL 3 Part 3 
I l l STAT. 2378 
PUBLIC LAW 105-115—NOV. 21, 1997 
"(1) AUTHORITY.—The Secretary may enter into a contract 
with any organization or any individual (who is not an employee 
of the Department) with relevant expertise, to review and evalu-
ate, for the purpose of making recommendations to the Sec-
retary on, part or all of any application or submission (including 
a petition, notification, and any other similar form of request) 
made under this Act for the approval or classification of an 
article or made under section 351(a) of the Public Health Serv-
ice Act (42 U.S.C. 262(a)) with respect to a biological product. 
Any such contract shall be subject to the requirements of section 
708 relating to the confidentiality of information, 
"(2) INCREASED EFFICIENCY AND EXPERTISE THROUGH CON-
TRACTS.—^The Secretary may use the authority granted in para-
graph (1) whenever the Secretary determines that use of a 
contract described in psiragraph (1) will improve the timeliness 
of the review of an application or submission described in 
paragraph (1), unless using such authority would reduce the 
quality, or unduly increase the cost, of such review. The Sec-
retary may use such authority whenever the Secretary deter-
mines that use of such a contract will improve the quality 
of the review of an application or submission described in 
paragraph (1), unless using such authority would unduly 
increase the cost of such review. Such improvement in timeli-
ness or quality may include providing the Secretary increased 
scientific or technical expertise that is necessary to review 
or evaluate new therapies and technologies. 
"(b) REVIEW OF EXPERT REVIEW.— 
"(1) IN GENERAL.—Subject to paragraph (2), the official 
of the Food and Drug Administration responsible for any matter 
for which expert review is used pursuant to subsection (a) 
shall review the recommendations of the organization or 
individual who conducted the expert review and shall make 
a final decision regarding the matter in a timely manner. 
"(2) LIMITATION.—^A final decision by the Secretary on any 
such application or submission shall be made within the 
applicable prescribed time period for review of the matter as 
set forth in this Act or in the Public Health Service Act (42 
U.S.C. 201 et seq.).". 
SEC. 416. PRODUCT CLASSIFICATION. 
Subchapter E of chapter V, as amended by section 404, is 
further amended by adding at the end the following: 
21 use 
"SEC. 563. CLASSIFICATION OF PRODUCTS. 
"(a) REQUEST,—^A person who submits an application or submis-
sion (including a petition, notification, and any other similar form 
of request) under this Act for a product, may submit a request 
to the Secretary respecting the classification of the product as 
a drug, biological product, device, or a combination product subject 
to section 503(g) or respecting the component of the Food and 
Drug Administration that will regulate the product. In submitting 
the request, the person shall recommend a classification for the 
product, or a component to regulate the product, as appropriate. 
"(b) STATEMENT.—Not later than 60 days after the receipt of 
the request described in subsection (a), the Secretary shall deter-
mine the classification of the product under subsection (a), or the 
component of the Food and Drug Administration that will regulate 
the product, and shall provide to the person a written statement 
PUBLIC LAW 105-115—NOV. 21, 1997 
111 STAT. 2379 
that identifies such classification or such component, and the rea-
sons for such determination. The Secretary may not modify such 
statement except with the written consent of the person, or for 
pubUc health reasons based on scientific evidence. 
"(c) INACTION OF SECRETARY.—If the Secretary does not provide 
the statement within the 60-day period described in subsection 
(b), the recommendation made by the person under subsection (a) 
shall be considered to be a final determination by the Secretary 
of such classification of the product, or the component of the Food 
and Drug Administration that will regulate the product, as 
applicable, and may not be modified by the Secretary except with 
the written consent of the person, or for public health reasons 
based on scientific evidence.". 
SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS. 
Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows: 
"(i)(l) Any establishment within any foreign country engaged 
in the manufacture, preparation, propagation, compounding, or 
processing of a drug or a device that is imported or offered for 
import into the United States shall register with the Secretary 
the name and place of business of the establishment and the nsune 
of the United States agent for the establishment. 
"(2) The establishment shall also provide the information 
required by subsection (j). 
"(3) The Secretary is authorized to enter into cooperative 
arrangements with officisils of foreign countries to ensure that ade-
quate and effective means are available for purposes of determining, 
from time to time, whether drugs or devices manufactured, pre-
pared, propagated, compounded, or processed by an establishment 
described in paragraph (1), if imported or offered for import into 
the United States, shall be refused admission on any of the grounds 
set forth in section 801(a).". 
SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY. 
Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended— 
(1) in the fifth sentence, by striking "paragraphs (1) and 
(2) of section 801(e)" and inserting "subparagraphs (A) and 
(B) of section 801(e)(1)"; and 
(2) by inserting after the fifth sentence the following: "Any 
person seeking to export an imported article pursuant to any 
of the provisions of this subsection shall establish that the 
article was intended for export at the time the article entered 
commerce.". 
SEC. 419. INTERSTATE COMMERCE. 
Section 709 (21 U.S.C. 379a) is amended by striking "a device" 
and inserting "a device, food, drug, or cosmetic". 
SEC. 420. SAFETY REPORT DISCLAIMERS. 
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
412, is further amended by adding at the end the following: 
"SUBCHAPTER G—SAFETY REPORTS 
"SEC. 756. SAFETY REPORT DISCLAIMERS. 
21 USC 379V. 
"With respect to any entity that submits or is required to 
submit a safety report or other information in connection with 
the safety of a product (including a product that is a food, drug. 
I l l STAT. 2380 
PUBLIC LAW 105-115—NOV. 21, 1997 
device, dietary supplement, or cosmetic) under this Act (and any 
release by the Secretary of that report or information), such report 
or information shall not be construed to reflect necessarily a conclu-
sion by the entity or the Secretary that the report or information 
constitutes an admission that the product involved malfunctioned, 
caused or contributed to an adverse experience, or otherwise caused 
or contributed to a death, serious injury, or serious illness. Such 
an entity need not admit, and may deny, that the report or informa-
tion submitted by the entity constitutes an admission that the 
product involved malfunctioned, caused or contributed to an adverse 
experience, or caused or contributed to a death, serious injury, 
or serious illness.". 
SEC. 421. LABELING AND ADVERTISING REGARDING 
COMPLIANCE 
WITH STATUTORY REQUIREMENTS. 
Section 301 (21 U.S.C. 331) is amended by striking paragraph 
(1). 
21 u s e 321 note. 
SEC. 422. RULE OF CONSTRUCTION. 
Nothing in this Act or the amendments made by this Act 
shall be construed to affect the question of whether the Secretary 
of Health and Human Services has any authority to regulate any 
tobacco product, tobacco ingredient, or tobacco additive. Such 
authority, if any, shall be exercised under the Federal Food, Drug, 
and Cosmetic Act as in effect on the day before the date of the 
enactment of this Act. 
TITLE V—EFFECTIVE DATE 
21 u s e 321 note. 
SEC. 501. EFFECTIVE DATE. 
Except as otherwise provided in this Act, this Act and the 
amendments made by this Act, other than the provisions of and 
the amendments made by sections 111, 121, 125, and 307, shall 
take effect 90 days after the date of enactment of this Act. 
Approved November 21, 1997. 
LEGISLATIVE HISTORY—S. 830 (H.R. 1411): 
HOUSE REPORTS: Nos. 105-310, accompanying H.R. 1411 (Comm. on Commerce) 
and 105-399 (Comm. of Conference). 
SENATE REPORTS: No. 105-43 (Comm. on Labor and Human Resources). 
CONGRESSIONAL RECORD, Vol. 143 (1997): 
Sept. 11, 16, 18, 19, 23, 24, considered and passed Senate. 
Oct. 7, considered and passed House, amended, in lieu of H.R. 1411. 
Nov. 9, Senate and House agreed to conference report. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 33 (1997): 
Nov. 21, Presidential remarks and statement.