Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices 10255 

information to be submitted to the DMC, 

FDA, or the sponsor. The ‘‘Hours per 

Record’’ include the time to record, 

gather, and maintain the information. 

The information collection provisions 

in the guidance for §§ 312.30 (21 CFR 

312.30), 312.32, 312.38 (21 CFR 312.38), 

312.55 (21 CFR 312.55), and 312.56 

have been approved under OMB control 

no. 0910–0014; § 314.50 has been 

approved under OMB control no. 0910– 

0001; and §§ 812.35 (21 CFR 812.35) 

and 812.150 have been approved under 

OMB control no. 0910–0078. 

In the Federal Register of October 8, 

2008 (73 FR 58970), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of Guidance/Reporting 

Activity 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

4.4.1.2. Sponsor notification to 

the DMC regarding waivers 1 1 1 .25 .25 

4.4.3.2. DMC reports of meeting 

minutes to the sponsor 370 2 740 1 740 

5. Sponsor reporting to FDA on 

DMC recommendations related 

to safety 37 1 37 .5 18.5 

Total 758.75 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Recordkeeping Activity No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours Per 

Record Total Hours 

4.1. and 6.4 SOPs for DMCs 37 1 37 8 296 

4.4.3.2. DMC meeting records 370 1 370 2 740 

Total 1,036 

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

Dated: March 3, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4971 Filed 3–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0650] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; General 

Administrative Procedures: Citizen 

Petitions; Petition for Reconsideration 

or Stay of Action; Advisory Opinions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 9, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0183. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

General Administrative Procedures: 

Citizen Petitions; Petition for 

Reconsideration or Stay of Action; 

Advisory Opinions—(OMB Control 

Number 0910–0183)—Extension 

The Administrative Procedures Act (5 

U.S.C. 553(e)) provides that every 

agency shall give an interested person 

the right to petition for issuance, 

amendment, or repeal of a rule. Section 

10.30 (21 CFR 10.30) sets forth the 

format and procedures by which an 

interested person may submit to FDA, in 

accordance with Sec. 10.20 (21 CFR 

10.20) (submission of documents to 

Division of Dockets Management), a 

citizen petition requesting the 

Commissioner of Food and Drugs (the 

Commissioner) to issue, amend, or 

revoke a regulation or order, or to take 

or refrain from taking any other form of 

administrative action. 

The Commissioner may grant or deny 

such a petition, in whole or in part, and 

may grant such other relief or take other 

action as the petition warrants. 

Respondents are individuals or 

households, State or local governments, 

not-for-profit institutions and 

businesses or other for-profit 

institutions or groups. 

10256 Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices 

Section 10.33 (21 CFR 10.33) issued 

under section 701(a) of the Federal, 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 371(a)), sets forth the format 

and procedures by which an interested 

person may request reconsideration of 

part or all of a decision of the 

Commissioner on a petition submitted 

under 21 CFR 10.25 (initiation of 

administrative proceedings). A petition 

for reconsideration must contain a full 

statement in a well-organized format of 

the factual and legal grounds upon 

which the petition relies. The grounds 

must demonstrate that relevant 

information and views contained in the 

administrative record were not 

previously or not adequately considered 

by the Commissioner. The respondent 

must submit a petition no later than 30 

days after the decision involved. 

However, the Commissioner may, for 

good cause, permit a petition to be filed 

after 30 days. An interested person who 

wishes to rely on information or views 

not included in the administrative 

record shall submit them with a new 

petition to modify the decision. FDA 

uses the information provided in the 

request to determine whether to grant 

the petition for reconsideration. 

Respondents to this collection of 

information are individuals of 

households, State or local governments, 

not-for-profit institutions, and 

businesses or other for-profit 

institutions who are requesting from the 

Commissioner of FDA a reconsideration 

of a matter. 

Section 10.35 (21 CFR 10.35), issued 

under section 701(a) of the act, sets forth 

the format and procedures by which an 

interested person may request, in 

accordance with § 10.20 (submission of 

documents to Division of Dockets 

Management), the Commissioner to stay 

the effective date of any administrative 

action. 

Such a petition must do the following: 

(1) Identify the decision involved; (2) 

state the action requested, including the 

length of time for which a stay is 

requested; and (3) include a statement of 

the factual and legal grounds on which 

the interested person relies in seeking 

the stay. FDA uses the information 

provided in the request to determine 

whether to grant the petition for stay of 

action. 

Respondents to this information 

collection are interested persons who 

choose to file a petition for an 

administrative stay of action. 

Section 10.85 (21 CFR 10.85), issued 

under section 701(a) of the act, sets forth 

the format and procedures by which an 

interested person may request, in 

accordance with § 10.20 (submission of 

documents to Division of Dockets 

Management), an advisory opinion from 

the Commissioner on a matter of general 

applicability. An advisory opinion 

represents the formal position of FDA 

on a matter of general applicability. 

When making a request, the petitioner 

must provide a concise statement of the 

issues and questions on which an 

opinion is requested, and a full 

statement of the facts and legal points 

relevant to the request. Respondents to 

this collection of information are 

interested persons seeking an advisory 

opinion from the Commissioner on the 

agency’s formal position for matters of 

general applicability. 

In the Federal Register of December 

30, 2008 (73 FR 79885), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

10.30 162 3 486 12 5,832 

10.33 4 2 8 10 80 

10.35 7 2 14 10 140 

10.85 2 1 2 16 32 

Total 6,084 

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

The burden estimates for this 

collection of information are based on 

agency records and experience over the 

past 3 years. In 2007, FDA received 

approximately 162 citizen petitions 

(§ 10.30), 4 administrative 

reconsiderations of action (§ 10.33), 7 

administrative stays of action (§ 10.35), 

and 2 advisory opinions (§ 10.85). 

Dated: March 3, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4972 Filed 3–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 1 and 2, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line,