50802 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 

1Section 505–1(b)(2) of the act (21 U.S.C. 

355(p)(1)) provides that section 505–1 of the act 

applies to applications for prescription drugs 

approved under section 505(b) or (j) of the act and 

applications approved under section 351 of the 

Public Health Service Act (42 U.S.C. 262). See 

Section 505(p)(1). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Format and Content 

of Proposed Risk Evaluation and 

Mitigation Strategies (REMS), REMS 

Assessments, and Proposed REMS 

Modifications.’’ The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) added new provisions to 

the Federal Food, Drug, and Cosmetic 

Act (the act) giving FDA the authority to 

require REMS. The draft guidance 

describes the format and content of a 

proposed risk evaluation and mitigation 

strategy, including REMS supporting 

documentation, the content of 

assessments and proposed 

modifications of approved REMS, what 

identifiers to use on REMS documents, 

and how to communicate with FDA 

about a REMS. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by December 30, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. The draft guidance may 

also be obtained by mail by calling 

CBER at 1–800–835–4709 or 301–827– 

1800. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. Submit written comments 

on the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding questions for the Center for 

Drug Evaluation and Research: 

Kathleen Frost, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4316, 

Silver Spring, MD 20993–0002, 

301–796–2380. 

Regarding questions for the Center for 

Biologics Evaluation and Research: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, Suite 200N, 

Rockville, MD 20852–1448, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Format and Content of Proposed Risk 

Evaluation and Mitigation Strategies 

(REMS), REMS Assessments, and 

Proposed REMS Modifications.’’ On 

September 27, 2007, the President 

signed into law FDAAA (Public Law 

110–85). Title IX, Subtitle A, section 

901 of FDAAA created new section 505– 

1 of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 355– 

1). Section 505–1(a) of the act authorizes 

FDA to require persons who submit 

certain applications or hold certain 

approved applications1 to submit a 

proposed REMS if FDA determines that 

a REMS is necessary to ensure that the 

benefits of a drug outweigh the risks of 

the drug and informs the holder of the 

application for the drug of the 

determination. Sections 505–1(c) 

through (f) describe the content of a 

required strategy. Section 505–1(g) 

describes assessments and 

modifications of an approved strategy. 

The draft guidance provides 

information regarding FDA’s current 

thinking on the format and content that 

should be used for submissions of 

proposed REMS, including a description 

of REMS supporting documentation. It 

also includes preliminary information 

on the content of assessments and 

proposed modifications of approved 

REMS, information on identifiers that 

should be included on the first page of 

REMS submissions, and information on 

whom to contact to communicate with 

FDA about a REMS. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the format and content of proposed 

REMS, REMS assessments, and 

proposed REMS modifications. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

the guidance was approved under OMB 

control numbers 0910–0001 and 0910– 

0338. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: September 25, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23616 Filed 9–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Children’s Study Advisory 

Committee. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Children’s 

Study Advisory Committee. 


PWALKER on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 50803 

Date: October 21, 2009. 

Time: 9 a.m. to 5 p.m. 

Agenda: The agenda will include a Report 

from the Director, NICHD, an update from the 

NCS Acting Director, discussions on 

recruitment strategies, the Vanguard Center 

protocol and interim outcome assessments. 

Additional information on the meeting 

logistics can be obtained on the conference 

Web site: http://www.circlesolutions.com/ 

ncs/ncsac/. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, Bethesda, 

MD 20892. 

Contact Person: Jessica Sapienza, 

Executive Secretary, National Children’s 

Study, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, NIH, 6100 Executive Blvd., 

Room 3A01, Bethesda, MD 20892. (703) 902– 

1339. ncs@circlesolutions.com. 

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 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, drivers license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 24, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23608 Filed 9–30–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

National Mammography Quality 

Assurance 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: National 

Mammography Quality Assurance 

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 November 2, 2009, from 9 a.m. 

to 5 p.m. 

Location: Holiday Inn, WalkerWhetstone Ballroom, Two Montgomery 

Village Ave., Gaithersburg, MD. 

Contact Person: Normica Facey, 

Center for Devices and Radiological 

Health (White Oak, Bldg. 66, rm. 4652), 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–5914, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512397. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting can not 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On November 2, 2009, the 

committee will discuss guidance 

documents issued since the last 

meeting. The committee will also 

receive updates on: Interventional 

mammography accreditation programs, 

recently approved alternative standards, 

facility inspection findings, the status of 

current inspection followup actions, 

and the radiological health program. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 29, 2009. 

Oral presentations from the public will 

be scheduled between approximately 

9:30 a.m. and 10:30 a.m. Those desiring 

to make formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before October 23, 2009. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 26, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, Conference Management 

Staff, 301–796–5966, at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 25, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23621 Filed 9–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 


PWALKER on DSK8KYBLC1PROD with NOTICES