60402 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Notices 

Dated: September 29, 2004. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC).

[FR Doc. 04–22603 Filed 10–7–04; 8:45 am] 

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0441]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

FDA Approval to Market a New Drug

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements governing applications for 

FDA approval to market a new drug.

DATES: Submit written or electronic 

comments on the collection of 

information by December 7, 2004.

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Management 

Programs (HFA 250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301 827 1482.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information listed below.

With respect to the following 

collection of information, FDA invites 

comments on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Applications for FDA Approval to 

Market a New Drug— 21 CFR Part 

314—(OMB Control Number 0910 

0001)—Extension

Under Section 505(a) of the Federal 

Food, Drug, and Cosmetic Act (the Act) 

(21 U.S.C. 355(a)), a new drug may not 

be commercially marketed in the United 

States, imported, or exported from the 

United States, unless an approval of an 

application filed with FDA under 

section 505(b) or 505(j) of the act is 

effective with respect to such drug. 

Section 505(b) and 505(j) of the act 

requires a sponsor to submit to FDA a 

new drug application (NDA) containing, 

among other things, full reports of 

investigations that show whether or not 

the drug is safe and effective for use, a 

full list of articles used as components 

in the drug, a full description of 

manufacturing methods, samples of the 

drugs required, specimens of the 

labeling proposed to be used, and 

certain patent information as applicable. 

Under the act, it is the sponsor’s 

responsibility to provide the 

information needed by FDA to make a 

scientific and technical determination 

that the product is safe and effective.

This information collection approval 

request is for all information 

requirements imposed on sponsors by 

the regulations under part 314 (21 CFR 

314), who apply for approval of a new 

drug application in order to market or 

to continue to market a drug.

Section 314.50(a) requires that an 

application form (Form FDA 356h) be 

submitted that includes introductory 

information about the drug as well as a 

checklist of enclosures.

Section 314.50(b) requires that an 

index be submitted with the archival 

copy of the application and that it 

reference certain sections of the 

application.

Section 314.50(c) requires that a 

summary of the application be 

submitted that presents a good general 

synopsis of all the technical sections 

and other information in the 

application.

Section 314.50(d) requires that the 

NDA contain the following technical 

sections about the new drug: Chemistry, 

manufacturing, and controls; 

nonclinical pharmacology and 

toxicology; human pharmacokinetics 

and bioavailability; microbiology; 

clinical data; and statistical section.

Section 314.50(e) requires the 

applicant to submit samples of the drug 

if requested by FDA. In addition, the 

archival copy of the application must 

include copies of the label and all 

labeling for the drug.

Section 314.50(f) requires that case 

report forms and tabulations be 

submitted with the archival copy.

Section 314.50(h) requires that patent 

information, as described under 

§ 314.53, be submitted with the 

application.

Section 314.50(i) requires that patent 

certification information be submitted 

in 505(b)(2) applications for patents 

claiming the drug, drug product, 

method of use, or method of 

manufacturing.

Section 314.50(j) requires that 

applicants that request a period of 

marketing exclusivity submit certain 

information with the application.

Section 314.50(k) requires that an 

archival, review, and field copy of the 

application be submitted.

Section 314.52 requires that notice of 

certification of invalidity or 

noninfringement of a patent to patent 

holders and NDA holders be sent by 

505(b)(2) applicants.

Section 314.54 sets forth the content 

requirements for applications filed 

under section 505(b)(2) of the act.

Section 314.60 sets forth reporting 

requirements for sponsors who amend 

an unapproved application.

Section 314.65 states that the sponsor 

must notify FDA when withdrawing an 

unapproved application.

Sections 314.70 and 314.71 require 

that supplements be submitted to FDA 

Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Notices 60403

for certain changes to an approved 

application.

Section 314.72 requires sponsors to 

report to FDA any transfer of ownership 

of an application.

Section 314.80(c)(1) and (c)(2) sets 

forth requirements for expedited 

adverse drug experience postmarketing 

reports and followup reports, as well as 

for periodic adverse drug experience 

postmarketing reports (Form FDA 

3500A). (The burden hours for 

§ 314.80(c)(1) and (c)(2) are already 

approved by OMB under 0910–0230 and 

0910–0291 and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.80(i) establishes 

recordkeeping requirements for reports 

of postmarketing adverse drug 

experiences. (The burden hours for 

§ 314.80(i) are already approved by 

OMB under 0910–0230 and 0910–0291 

and are not included in the hour burden 

estimates in table 1 of this document).

Section 314.81(b)(1) requires that field 

alert reports be submitted to FDA (Form 

FDA 3331).

Section 314.81(b)(2) requires that 

annual reports be submitted to FDA 

(Form FDA 2252). This form has been 

revised as a result of the requirements 

in the final rule ‘‘Postmarketing Studies 

for Approved Human Drug and 

Licensed Biological Products; Status 

Reports,’’ published in the Federal 

Register of October 30, 2000 (65 FR 

64607). The rule describes the types of 

postmarketing studies covered by the 

status reports, the information to be 

included in the reports, and the type of 

information that FDA would consider 

appropriate for public disclosure. The 

rule implemented section 130(a) of the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA). 

The changes to the form include adding 

new spaces for the new status reports, 

reporting for biological products, and 

editorial changes. A copy of the revised 

form is available at http://www.fda.gov/

dockets/ecomments, using the docket 

number of this proposed collection of 

information.

Section 314.81(b)(3)(i) requires that 

drug advertisements and promotional 

labeling be submitted to FDA (Form 

FDA 2253).

Section 314.81(b)(3)(iii) sets forth 

reporting requirements for sponsors 

who withdraw an approved drug 

product from sale. (The burden hours 

for § 314.81(b)(3)(iii) are already 

approved by OMB under 0910–0045 and 

are not included in the hour burden 

estimates in table 1 of this document).

Section 314.90 sets forth requirements 

for sponsors who request waivers from 

FDA for compliance with §§ 314.50 

through 314.81. (The information 

collection hour burden estimate for 

NDA waiver requests is included in 

table 1 of this document under estimates 

for §§ 314.50, 314.60, 314.70 and 

314.71).

Section 314.93 sets forth requirements 

for submitting a suitability petition in 

accordance with 21 CFR 10.20 and 

10.30. (The burden hours for § 314.93 

are already approved by OMB under 

0910–0183 and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.94(a) and (d) requires that 

an abbreviated new drug application 

(ANDA) contain the following 

information: Application form; table of 

contents; basis for ANDA submission; 

conditions of use; active ingredients; 

route of administration, dosage form, 

and strength; bioequivalence; labeling; 

chemistry, manufacturing, and controls; 

samples; patent certification.

Section 314.95 requires that notice of 

certification of invalidity or 

noninfringement of a patent to patent 

holders and NDA holders be sent by 

ANDA applicants.

Section 314.96 sets forth requirements 

for amendments to an unapproved 

ANDA.

Section 314.97 sets forth requirements 

for submitting supplements to an 

approved ANDA for changes that 

require FDA approval.

Section 314.98(a) sets forth 

postmarketing adverse drug experience 

reporting and recordkeeping 

requirements for ANDAs. (The burden 

hours for § 314.98(a) are already 

approved by OMB under 0910–0230 and 

0910–0291 and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.98(c) requires other 

postmarketing reports for ANDAs: Field 

alert reports (Form FDA 3331), annual 

reports (Form FDA 2252), and 

advertisements and promotional 

labeling (Form FDA 2253). (The 

information collection hour burden 

estimate for field alert reports is 

included in table 1 of this document 

under § 314.81(b)(1); the estimate for 

annual reports is included under 

§ 314.81(b)(2); the estimate for 

advertisements and promotional 

labeling is included under 

§ 314.81(b)(3)(i)).

Section 314.99(a) requires that 

sponsors comply with certain reporting 

requirements for withdrawing an 

unapproved ANDA and for a change in 

ownership of an ANDA.

Section 314.99(b) sets forth 

requirements for sponsors who request 

waivers from FDA for compliance with 

§§ 314.92 through 314.99. (The 

information collection hour burden 

estimate for ANDA waiver requests is 

included in table 1 of this document 

under estimates for §§ 314.94(a) and (d), 

314.96, and 314.97).

Section 314.101(a) states that if FDA 

refuses to file an application, the 

applicant may request an informal 

conference with FDA and request that 

the application befiled over protest.

Section 314.107(c)(4) requires notice 

to FDA by ANDA or 505(b)(2) 

application holders of any legal action 

concerning patent infringement.

Section 314.107(e)(2)(iv) requires that 

an applicant submit a copy of the entry 

of the order or judgment to FDA within 

10 working days of a final judgment.

Section 314.107(f) requires that 

ANDA or 505(b)(2) applicants notify 

FDA of the filing of any legal action 

filed within 45 days of receipt of the 

notice of certification. A patent owner 

may also notify FDA of the filing of any 

legal action for patent infringement. The 

patent owner or approved application 

holder who is an exclusive patent 

licensee must submit to FDA a waiver 

that waives the opportunity to file a 

legal action for patent infringement.

Section 314.110(a)(3) and (a)(4) states 

that, after receipt of an FDA approvable 

letter, an applicant may request an 

opportunity for a hearing on the 

question of whether there are grounds 

for denying approval of the application. 

(The burden hours for § 314.110(a)(3) 

and (a)(4) are included under the parts 

10 through 16 (21 CFR parts 10 through 

16) hearing regulations, in accordance 

with § 314.201, and are not included in 

the hour burden estimates in table 1 of 

this document).

Section 314.110(a)(5) states that, after 

receipt of an approvable letter, an 

applicant may notify FDA that it agrees 

to an extension of the review period so 

that it can determine whether to 

respond further.

Section 314.110(b) states that, after 

receipt of an approvable letter, an 

ANDA applicant may request an 

opportunity for a hearing on the 

question of whether there are grounds 

for denying approval of the application. 

(The burden hours for § 314.110(b) are 

included under the parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.120(a)(3) states that, after 

receipt of a not approvable letter, an 

applicant may request an opportunity 

for a hearing on the question of whether 

there are grounds for denying approval 

of the application. (The burden hours 

for § 314.120(a)(3) are included under 

the parts 10 through 16 hearing 

60404 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Notices 

regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.120(a)(5) states that, after 

receipt of a not approvable letter, an 

applicant may notify FDA that it agrees 

to an extension of the review period so 

that it can determine whether to 

respond further.

Section 314.122(a) requires that an 

ANDA or a suitability petition that 

relies on a listed drug that has been 

voluntarily withdrawn from sale must 

be accompanied by a petition seeking a 

determination whether the drug was 

withdrawn for safety or effectiveness 

reasons. (The burden hours for 

§ 314.122(a) are already approved by 

OMB under 0910–0183 and are not 

included in the hour burden estimates 

in table 1 of this document).

Section 314.122(d) sets forth 

requirements for relisting petitions for 

unlisted discontinued products. (The 

burden hours for § 314.122(d) are 

already approved by OMB under 0910–

0183 and are not included in the hour 

burden estimates in table 1 of this 

document).

Section 314.126(c) sets forth 

requirements for a petition to waive 

criteria for adequate and well-controlled 

studies. (The burden hours for 

§ 314.126(c) are already approved by 

OMB under 0910–0183 and are not 

included in the hour burden estimates 

in table 1 of this document).

Section 314.151(a) and (b) set forth 

requirements for the withdrawal of 

approval of an ANDA and the 

applicant’s opportunity for a hearing 

and submission of comments. (The 

burden hours for § 314.151(a) and (b) are 

included under the parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.151(c) sets forth the 

requirements for withdrawal of approval 

of an ANDA and the applicant’s 

opportunity to submit written objections 

and participate in a limited oral hearing. 

(The burden hours for § 314.151(c) are 

included under the parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.152(b) sets forth the 

requirements for suspension of an 

ANDA when the listed drug is 

voluntarily withdrawn for safety and 

effectiveness reasons, and the 

applicant’s opportunity to present 

comments and participate in a limited 

oral hearing. (The burden hours for 

§ 314.152(b) is included under the parts 

10 through 16 hearing regulations, in 

accordance with § 314.201, and is not 

included in the hour burden estimates 

in table 1 of this document).

Section 314.161(b) and (e) sets forth 

the requirements for submitting a 

petition to determine whether a listed 

drug was voluntarily withdrawn from 

sale for safety or effectiveness reasons. 

(The burden hours for § 314.161(b) and 

(e) are already approved by OMB under 

0910–0183 and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.200(c), (d), and (e) 

requires that applicants or others subject 

to a notice of opportunity for a hearing 

who wish to participate in a hearing file 

a written notice of participation and 

request for a hearing as well as the 

studies, data, and so forth, relied on. 

Other interested persons may also 

submit comments on the notice. This 

section also sets forth the content and 

format requirements for the applicants’

submission in response to notice of 

opportunity for hearing. (The burden 

hours for § 314.200(c), (d), and (e) are 

included under the parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.200(f) states that 

participants in a hearing may make a 

motion to the presiding officer for the 

inclusion of certain issues in the 

hearing. (The burden hours for 

§ 314.200(f) are included under the parts 

10 through 16 hearing regulations, in 

accordance with § 314.201, and are not 

included in the hour burden estimates 

in table 1 of this document).

Section 314.200(g) states that a person 

who responds to a proposed order from 

FDA denying a request for a hearing 

provide sufficient data, information, and 

analysis to demonstrate that there is a 

genuine and substantial issue of fact 

which justifies a hearing. (The burden 

hours for § 314.200(g) are included 

under the parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and is not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.420 states that an 

applicant may submit to FDA a drug 

master file in support of an application, 

in accordance with certain content and 

format requirements.

Section 21 CFR 314.430 states that 

data and information in an application 

are disclosable under certain conditions, 

unless the applicant shows that 

extraordinary circumstances exist. (The 

burden hours for § 314.430 is included 

under the parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and is not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.530(c) and (e) states that, 

if FDA withdraws approval of a drug 

approved under the accelerated 

approval procedures, the applicant has 

the opportunity to request a hearing and 

submit data and information. (The 

burden hours for § 314.530(c) and (e) are 

included under the parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document).

Section 314.530(f) requires that an 

applicant first submit a petition for stay 

of action before requesting an order 

from a court for a stay of action pending 

review. (The burden hours for 

§ 314.530(f) are already approved by 

OMB under 0910–0194 and are not 

included in the hour burden estimates 

in table 1 of this document).

Respondents to this collection of 

information are all persons who submit 

an application or abbreviated 

application or an amendment or 

supplement to FDA under part 314 to 

obtain approval of a new drug, and any 

person who owns an approved 

application or abbreviated application.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section; [Form Number] No. of Respondents No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours Per Response Total Hours 

314.50 (a), (b), (c), (d), (e), (f), (h), and (k) 72 1.44 104 1,642 170,768

314.50(i) and 314.94(a)(12) 194 2.34 454 2 908

314.50(j) 70 3.71 260 2 520

Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Notices 60405

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

21 CFR Section; [Form Number] No. of Respondents No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours Per Response Total Hours 

314.52 and 314.95 24 2.25 54 16 864

314.54 16 1 16 300 4,800

314.60 275 19.06 5,242 80 419,320

314.65 10 1 10 2 20

314.70 and 314.71 234 10.99 2,572 150 385,800

314.72 61 4.52 276 2 552

314.81(b)(1) [3331] 115 3.88 447 8 3,576

314.81(b)(2) [2252] 612 12.47 7,632 40 305,280

314.81(b)(3)(i) [2253] 332 44.09 14,638 2 29,276

314.94(a) and (d) 100 4.59 459 480 220,320

314.96 275 23.63 6,500 80 520,000

314.97 200 16.75 3,350 80 268,000

314.99(a) 44 2.02 89 2 178

314.101(a) 2 1 2 .50 1

314.107(c)(4), 314.107(e)(2)(iv), and 

314.107(f) 3 2 6 1 6

314.110(a)(5) 41 1.26 52 .50 26

314.120(a)(5) 12 1.16 14 .50 7

314.420 403 1.72 694 61 42,334

Total 2,372,556

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: October 5, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22815 Filed 10–6–04; 11:56 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

Board of Scientific Counselors, National 

Cancer Institute. The meeting will be 

closed to the public as indicated below 

in accordance with the provisions set 

forth in section 552b(c)(6), Title 5 

U.S.C., as amended for the review, 

discussion, and evaluation of individual 

intramural programs and projects 

conducted by the National Cancer 

Institute, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy.

Name of Committee: Board of Scientific 

Counselors, National Cancer Institute, 

Subcommittee 2—Basic Sciences. 

Date: November 15–16, 2004. 

Time: November 15, 2004, 7 p.m. to 9 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: Holiday Inn Bethesda, Versailles IV, 

8120 Wisconsin Avenue, Bethesda, MD 

20814. 

Time: November 16, 2004, 8:30 a.m. to 5 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

National Cancer Institute, Building 31, 

Conference Room 6, 9000 Rockville Pike, 

Bethesda, MD 20892. 

Contact Person: Florence E. Farber, PhD, 

Health Scientific Administrator, Office of the 

Director, National Cancer Institute, National 

Institutes of Health, 6116 Executive 

Boulevard, Room 2115, Bethesda, MD 20892, 

(301) 496–7628, ff6p@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

into the building by non-government 

employees. Persons without a government 

I.D. will need to show a photo I.D. and signin at the security desk upon entering the 

building.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS)