datamatters24/research-document-archive huggingface dataset:
216 
information exempted from disclosure under 
section 552 of title 5, United States Code, and 
section 552a of title 5, United States Code) on 
the Internet Web site of the Food and Drug 
Administration, the information described in 
clauses (i) and (ii) of subparagraph (A) as soon 
as practicable after the Secretary makes such 
determination, certification, or waiver, but in no 
case later than the date of such meeting. 
‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 
that the public record and transcript of each meeting of 
an advisory committee includes the disclosure required 
under subsection (c)(3) (other than information exempted 
from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code). 
‘‘(e) ANNUAL REPORT.—Not later than February 1 
of each year, the Secretary shall submit to the Committee 
on Appropriations and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, and the Com-
mittee on Appropriations and the Committee on Energy 
and Commerce of the House of Representatives a report 
that describes— 
‘‘(1) with respect to the fiscal year that ended 
on September 30 of the previous year, the number 
of vacancies on each advisory committee, the number
106TH CONGRESS
2D SESSION
H. R. 5267
AN ACT
To designate the United States courthouse located at 100
Federal Plaza in Central Islip, New York, as the ‘‘Theo-
dore Roosevelt United States Courthouse’’.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
217 
of nominees received for each committee, and the 
number of such nominees willing to serve; 
‘‘(2) with respect to such year, the aggregate 
number of disclosures required under subsection 
(c)(3) for each meeting of each advisory committee 
and the percentage of individuals to whom such dis-
closures did not apply who served on such committee 
for each such meeting; 
‘‘(3) with respect to such year, the number of 
times the disclosures required under subsection 
(c)(3) occurred under subparagraph (B) of such sub-
section; and 
‘‘(4) how the Secretary plans to reduce the 
number of vacancies reported under paragraph (1) 
during the fiscal year following such year, and mech-
anisms to encourage the nomination of individuals 
for service on an advisory committee, including those 
who are classified by the Food and Drug Adminis-
tration as academicians or practitioners. 
‘‘(f) PERIODIC REVIEW
OF GUIDANCE.—Not less 
than once every 5 years, the Secretary shall review guid-
ance of the Food and Drug Administration regarding con-
flict of interest waiver determinations with respect to advi-
sory committees and update such guidance as necessary.’’.
218 
(b) CONFORMING AMENDMENTS.—Section 505(n) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(n)) is amended by— 
(1) striking paragraph (4); and 
(2) redesignating paragraphs (5), (6), (7), and 
(8) as paragraphs (4), (5), (6), and (7), respectively. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on October 1, 2007. 
TITLE VIII—CLINICAL TRIAL 
DATABASES 
SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA 
BANK. 
(a) IN GENERAL.—Section 402 of the Public Health 
Service Act (42 U.S.C. 282) is amended by— 
(1) redesignating subsections (j) and (k) as 
subsections (k) and (l), respectively; and 
(2) inserting after subsection (i) the following: 
‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA 
BANK.— 
‘‘(1) DEFINITIONS; REQUIREMENT.— 
‘‘(A) DEFINITIONS.—In this subsection: 
‘‘(i) APPLICABLE CLINICAL TRIAL.— 
The term ‘applicable clinical trial’ means 
an applicable device clinical trial or an ap-
plicable drug clinical trial.
II 
Calendar No. 117 
110TH CONGRESS 
2D SESSION 
H. R. 6842 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 18 (legislative day, SEPTEMBER 17), 2008 
Received and read the first time 
NOVEMBER 18, 2008 
Read the second time and placed on the calendar under authority of the order 
of the Senate of November 17 (legislative day, September 17), 2008 
AN ACT 
To restore Second Amendment rights in the District of 
Columbia. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Second Amendment 
Enforcement Act’’. 
SEC. 2. CONGRESSIONAL FINDINGS. 
Congress finds the following: 
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137 
of this subsection, even though benefits were 
being provided to the individual pursuant to a 
settlement agreement approved by order of a 
bankruptcy court entered on or before Sep-
tember 30, 2004, will be considered to be actu-
ally enrolled in the Plan and shall receive bene-
fits from the Plan beginning on December 31, 
2006. 
‘‘(3) ADJUSTMENT.—If, for any fiscal year, the 
amount of a transfer under subparagraph (A), (B), 
or (C) of paragraph (2) is more or less than the 
amount required to be transferred under that sub-
paragraph, the Secretary shall appropriately adjust 
the amount transferred under that subparagraph for 
the next fiscal year. 
‘‘(4) ADDITIONAL AMOUNTS.— 
‘‘(A) PREVIOUSLY CREDITED INTEREST.— 
Notwithstanding any other provision of law, any 
interest credited to the fund that has not pre-
viously been transferred to the Combined Ben-
efit Fund referred to in paragraph (2)(A) under 
this section— 
‘‘(i) shall be held in reserve by the 
Secretary until such time as necessary to 
make the payments under subparagraphs 
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106TH CONGRESS
2D SESSION
H. R. 5273
AN ACT
To clarify the intention of the Congress with regard
to the authority of the United States Mint to
produce numismatic coins, and for other pur-
poses.
138 
(A) and (B) of subsection (i)(1), as de-
scribed in clause (ii); and 
‘‘(ii) in the event that the amounts de-
scribed in subsection (i)(1) are insufficient 
to make the maximum payments described 
in subparagraphs (A) and (B) of sub-
section (i)(1), shall be used by the Sec-
retary to supplement the payments so that 
the maximum amount permitted under 
those paragraphs is paid. 
‘‘(B) 
PREVIOUSLY
ALLOCATED 
AMOUNTS.—All amounts allocated under sub-
section (g)(2) before the date of enactment of 
this subparagraph for the program described in 
section 406, but not appropriated before that 
date, shall be available to the Secretary to make 
the transfers described in paragraph (2). 
‘‘(C) ADEQUACY
OF
PREVIOUSLY
CRED-
ITED INTEREST.—The Secretary shall— 
‘‘(i) consult with the trustees of the 
plans described in paragraph (2) at rea-
sonable intervals; and 
‘‘(ii) notify Congress if a determina-
tion is made that the amounts held in re-
serve under subparagraph (A) are insuffi-
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106TH CONGRESS
2D SESSION
H. R. 5273
AN ACT
To clarify the intention of the Congress with regard to the
authority of the United States Mint to produce numis-
matic coins, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
170
‘‘(b) REVIEW BY GOVERNORS.—A unit of general local
government shall give the chief executive officer of the State
in which the government is located an opportunity for re-
view and comment before establishing compliance with sub-
section (a).
‘‘(c) SANCTIONS FOR NONCOMPLIANCE.—(1) If the Sec-
retary decides that a unit of general local government has
not complied substantially with subsection (a) or regula-
tions prescribed under subsection (a), the Secretary shall
notify the government. The notice shall state that if the gov-
ernment does not take corrective action by the 60th day
after the date the government receives the notice, the Sec-
retary will withhold additional payments to the government
for the current payment period and later payment periods
until the Secretary is satisfied that the government—
‘‘(A) has taken the appropriate corrective action;
and
‘‘(B) will comply with subsection (a) and regula-
tions prescribed under subsection (a).
‘‘(2) Before giving notice under paragraph (1), the
Secretary shall give the chief executive officer of the unit
of general local government reasonable notice and an oppor-
tunity for a proceeding.
106TH CONGRESS
2D SESSION
H. R. 5284
AN ACT
To designate the United States customhouse lo-
cated at 101 East Main Street in Norfolk, Vir-
ginia, as the ‘‘Owen B. Pickett United States
Customhouse’’.
I 
110TH CONGRESS 
2D SESSION 
H. R. 6711 
To provide for increased funding for veterans health care for fiscal year 
2009 by transferring amounts from the National Endowment for the 
Humanities and the National Endowment for the Arts, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 31, 2008 
Mr. HENSARLING introduced the following bill; which was referred to the 
Committee on Veterans’ Affairs, and in addition to the Committee on 
Education and Labor, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To provide for increased funding for veterans health care 
for fiscal year 2009 by transferring amounts from the 
National Endowment for the Humanities and the Na-
tional Endowment for the Arts, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Veterans Community 
Health Enhancement Act of 2008’’. 
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139 
cient to meet future requirements under 
subparagraph (A)(ii). 
‘‘(D) ADDITIONAL
RESERVE
AMOUNTS.— 
In addition to amounts held in reserve under 
subparagraph (A), there is authorized to be ap-
propriated such sums as may be necessary for 
transfer to the fund to carry out the purposes 
of subparagraph (A)(ii). 
‘‘(E) INAPPLICABILITY OF CAP.—The limi-
tation described in subsection (i)(3)(A) shall 
not apply to payments made from the reserve 
fund under this paragraph. 
‘‘(5) LIMITATIONS.— 
‘‘(A) AVAILABILITY OF FUNDS FOR NEXT 
FISCAL YEAR.—The Secretary may make trans-
fers under subparagraphs (B) and (C) of para-
graph (2) for a calendar year only if the Sec-
retary determines, using actuarial projections 
provided by the trustees of the Combined Ben-
efit Fund referred to in paragraph (2)(A), that 
amounts will be available under paragraph (1), 
after the transfer, for the next fiscal year for 
making the transfer under paragraph (2)(A). 
‘‘(B) RATE OF CONTRIBUTIONS OF OBLI-
GORS.— 
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219 
‘‘(ii) APPLICABLE
DEVICE
CLINICAL 
TRIAL.—The term ‘applicable device clin-
ical trial’ means— 
‘‘(I) a prospective clinical study 
of health outcomes comparing an 
intervention with a device subject to 
section 510(k), 515, or 520(m) of the 
Federal Food, Drug, and Cosmetic 
Act against a control in human sub-
jects (other than a small clinical trial 
to determine the feasibility of a de-
vice, or a clinical trial to test proto-
type devices where the primary out-
come measure relates to feasibility 
and not to health outcomes); and 
‘‘(II) a pediatric postmarket sur-
veillance as required under section 
522 of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(iii) APPLICABLE
DRUG
CLINICAL 
TRIAL.— 
‘‘(I) IN
GENERAL.—The term 
‘applicable drug clinical trial’ means a 
controlled clinical investigation, other 
than a phase I clinical investigation,
188
ment shall hold the hearing at a time and a place that al-
lows and encourages public attendance and participation.
‘‘(2) A unit of general local government holding a hear-
ing required under this subsection or by the budget process
of the government shall try to provide senior citizens and
senior citizen organizations with an opportunity to present
views at the hearing before the government makes a final
decision on the use of the payment.
‘‘(b) DISCLOSURE OF INFORMATION.—(1) By the 10th
day before a hearing required under subsection (a)(1) is
held, a unit of general local government shall—
‘‘(A) make available for inspection by the public
at the principal office of the government a statement
of the proposed use of the payment and a summary
of the proposed budget of the government; and
‘‘(B) publish in at least one newspaper of gen-
eral circulation the proposed use of the payment with
the summary of the proposed budget and a notice of
the time and place of the hearing.
‘‘(2) By the 30th day after adoption of the budget
under State or local law, the government shall—
‘‘(A) make available for inspection by the public
at the principal office of the government a summary
of the adopted budget, including the proposed use of
the payment; and
140 
‘‘(i) IN GENERAL.— 
‘‘(I) RATE.—A transfer under 
paragraph (2)(C) shall not be made 
for a calendar year unless the persons 
that are obligated to contribute to the 
plan referred to in paragraph (2)(C) 
on the date of the transfer are obli-
gated to make the contributions at 
rates that are no less than those in ef-
fect on the date which is 30 days be-
fore the date of enactment of this sub-
section. 
‘‘(II) APPLICATION.—The con-
tributions described in subclause (I) 
shall be applied first to the provision 
of benefits to those plan beneficiaries 
who are not described in paragraph 
(2)(C)(ii). 
‘‘(ii) INITIAL CONTRIBUTIONS.— 
‘‘(I) IN
GENERAL.—From the 
date of enactment of the Surface Min-
ing Control and Reclamation Act 
Amendments of 2006 through Decem-
ber 31, 2010, the persons that, on the 
date of enactment of that Act, are ob-
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141 
ligated to contribute to the plan re-
ferred to in paragraph (2)(C) shall be 
obligated, collectively, to make con-
tributions equal to the amount de-
scribed in paragraph (2)(C), less the 
amount actually transferred due to 
the operation of subparagraph (C). 
‘‘(II) FIRST CALENDAR YEAR.— 
Calendar year 2006 is the first cal-
endar year for which contributions are 
required under this clause. 
‘‘(III) AMOUNT
OF
CONTRIBU-
TION FOR 2006.—Except as provided 
in subclause (IV), the amount de-
scribed in paragraph (2)(C) for cal-
endar year 2006 shall be calculated as 
if paragraph (2)(C) had been in effect 
during 2005. 
‘‘(IV) 
LIMITATION.—The 
con-
tributions required under this clause 
for calendar year 2006 shall not ex-
ceed the amount necessary for sol-
vency of the plan described in para-
graph (2)(C), measured as of Decem-
ber 31, 2006 and taking into account 
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142 
all assets held by the plan as of that 
date. 
‘‘(iii) DIVISION.—The collective an-
nual contribution obligation required under 
clause (ii) shall be divided among the per-
sons subject to the obligation, and applied 
uniformly, based on the hours worked for 
which contributions referred to in clause 
(i) would be owed. 
‘‘(C) PHASE-IN OF TRANSFERS.—For each 
of calendar years 2008 through 2010, the 
transfers required under subparagraphs (B) 
and (C) of paragraph (2) shall equal the fol-
lowing amounts: 
‘‘(i) For calendar year 2008, the Sec-
retary shall make transfers equal to 25 
percent of the amounts that would other-
wise be required under subparagraphs (B) 
and (C) of paragraph (2). 
‘‘(ii) For calendar year 2009, the Sec-
retary shall make transfers equal to 50 
percent of the amounts that would other-
wise be required under subparagraphs (B) 
and (C) of paragraph (2). 
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234 
‘‘(II) NIH INFORMATION.—The 
Secretary shall ensure that the reg-
istry data bank includes links to the 
following information: 
‘‘(aa) Medline citations to 
any publications focused on the 
results of an applicable clinical 
trial. 
‘‘(bb) The entry for the drug 
that is the subject of an applica-
ble drug clinical trial in the Na-
tional Library of Medicine data-
base of structured product labels, 
if available. 
‘‘(iii) RESULTS FOR EXISTING DATA 
BANK
ENTRIES.—The Secretary may in-
clude the links described in clause (ii) for 
data bank entries for clinical trials sub-
mitted to the data bank prior to enactment 
of the Food and Drug Administration 
Amendments Act of 2007, as available. 
‘‘(B) INCLUSION OF RESULTS.—The Sec-
retary, acting through the Director of NIH, 
shall—
235 
‘‘(i) expand the registry data bank to 
include the results of applicable clinical 
trials (referred to in this subsection as the 
‘registry and results data bank’); 
‘‘(ii) ensure that such results are 
made publicly available through the Inter-
net; 
‘‘(iii) post publicly a glossary for the 
lay public explaining technical terms re-
lated to the results of clinical trials; and 
‘‘(iv) in consultation with experts on 
risk communication, provide information 
with the information included under sub-
paragraph (C) in the registry and results 
data bank to help ensure that such infor-
mation does not mislead the patients or 
the public. 
‘‘(C) BASIC RESULTS.—Not later than 1 
year after the date of the enactment of the 
Food and Drug Administration Amendments 
Act of 2007, the Secretary shall include in the 
registry and results data bank the following ele-
ments for drugs that are approved under sec-
tion 505 of the Federal Food, Drug, and Cos-
metic Act or licensed under section 351 of this
143 
‘‘(iii) For calendar year 2010, the 
Secretary shall make transfers equal to 75 
percent of the amounts that would other-
wise be required under subparagraphs (B) 
and (C) of paragraph (2). 
‘‘(i) FUNDING.— 
‘‘(1) IN GENERAL.—Subject to paragraph (3), 
out of any funds in the Treasury not otherwise ap-
propriated, the Secretary of the Treasury shall 
transfer to the plans described in subsection (h)(2) 
such sums as are necessary to pay the following 
amounts: 
‘‘(A) To the Combined Fund (as defined in 
section 9701(a)(5) of the Internal Revenue 
Code of 1986 and referred to in this paragraph 
as the ‘Combined Fund’), the amount that the 
trustees of the Combined Fund estimate will be 
expended from premium accounts maintained 
by the Combined Fund for the fiscal year to 
provide benefits for beneficiaries who are unas-
signed beneficiaries solely as a result of the ap-
plication of section 9706(h)(1) of the Internal 
Revenue Code of 1986, subject to the following 
limitations: 
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HR 6842 PCS 
serting ‘‘which are prohibited under section 
201’’. 
(4) Section 402 (sec. 7—2504.02, D.C. Official 
Code) is amended— 
(A) in subsection (a), by striking ‘‘Any 
person eligible to register a firearm’’ and all 
that follows through ‘‘such business,’’ and in-
serting the following: ‘‘Any person not other-
wise prohibited from possessing or receiving a 
firearm under Federal or District law, or from 
being licensed under section 923 of title 18, 
United States Code,’’; and 
(B) in subsection (b), by amending para-
graph (1) to read as follows: 
‘‘(1) The applicant’s name;’’. 
(5) Section 403(b) (sec. 7—2504.03(b), D.C. 
Official Code) is amended by striking ‘‘registration 
certificate’’ and inserting ‘‘dealer’s license’’. 
(6) Section 404(a)(3) (sec. 7—2504.04(a)(3)), 
D.C. Official Code) is amended— 
(A) in subparagraph (B)(i), by striking 
‘‘registration certificate number (if any) of the 
firearm,’’; 
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106TH CONGRESS
2D SESSION
H. R. 5284
AN ACT
To designate the United States customhouse located at 101
East Main Street in Norfolk, Virginia, as the ‘‘Owen
B. Pickett United States Customhouse’’.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
106TH CONGRESS
2D SESSION
H. R. 5302
AN ACT
To designate the United States courthouse located
at 1010 Fifth Avenue in Seattle, Washington, as
the ‘‘William Kenzo Nakamura United States
Courthouse’’.
HR 6842 RDS
loading of ammunition for firearms lawfully 
possessed under this Act.’’; and 
(B) in subsection (b), by striking ‘‘which 
are unregisterable under section 202’’ and in-
serting ‘‘which are prohibited under section 
201’’. 
(4) Section 402 (sec. 7—2504.02, D.C. Official 
Code) is amended— 
(A) in subsection (a), by striking ‘‘Any 
person eligible to register a firearm’’ and all 
that follows through ‘‘such business,’’ and in-
serting the following: ‘‘Any person not other-
wise prohibited from possessing or receiving a 
firearm under Federal or District law, or from 
being licensed under section 923 of title 18, 
United States Code,’’; and 
(B) in subsection (b), by amending para-
graph (1) to read as follows: 
‘‘(1) The applicant’s name;’’. 
(5) Section 403(b) (sec. 7—2504.03(b), D.C. 
Official Code) is amended by striking ‘‘registration 
certificate’’ and inserting ‘‘dealer’s license’’. 
(6) Section 404(a)(3) (sec. 7—2504.04(a)(3)), 
D.C. Official Code) is amended— 
VerDate Aug 31 2005 
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236 
Act and devices that are cleared under section 
510(k) of the Federal Food, Drug, and Cos-
metic Act or approved under section 515 or 
520(m) of such Act: 
‘‘(i) DEMOGRAPHIC
AND
BASELINE 
CHARACTERISTICS OF PATIENT SAMPLE.— 
A table of the demographic and baseline 
data collected overall and for each arm of 
the clinical trial to describe the patients 
who participated in the clinical trial, in-
cluding the number of patients who 
dropped out of the clinical trial and the 
number of patients excluded from the anal-
ysis, if any. 
‘‘(ii) PRIMARY AND SECONDARY OUT-
COMES.—The primary and secondary out-
come measures as submitted under para-
graph (2)(A)(ii)(I)(ll), and a table of val-
ues for each of the primary and secondary 
outcome measures for each arm of the clin-
ical trial, including the results of scientif-
ically appropriate tests of the statistical 
significance of such outcome measures.
H. Res. 701 
In the House of Representatives, U. S., 
October 3, 2007. 
Resolved, That at any time after the adoption of this res-
olution the Speaker may, pursuant to clause 2(b) of rule 
XVIII, declare the House resolved into the Committee of the 
Whole House on the state of the Union for consideration of 
the bill (H.R. 928) to amend the Inspector General Act of 
1978 to enhance the independence of the Inspectors General, 
to create a Council of the Inspectors General on Integrity and 
Efficiency, and for other purposes. The first reading of the 
bill shall be dispensed with. All points of order against con-
sideration of the bill are waived except those arising under 
clause 9 or 10 of rule XXI. General debate shall be confined 
to the bill and shall not exceed one hour equally divided and 
controlled by the chairman and ranking minority member of 
the Committee on Oversight and Government Reform. After 
general debate the bill shall be considered for amendment 
under the five-minute rule. It shall be in order to consider as 
an original bill for the purpose of amendment under the five- 
minute rule the amendment in the nature of a substitute rec-
106TH CONGRESS
2D SESSION
H. R. 5302
AN ACT
To designate the United States courthouse located at 1010
Fifth Avenue in Seattle, Washington, as the ‘‘William
Kenzo Nakamura United States Courthouse’’.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,