Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 17967 

Agenda: To discuss the annual strategic 

plan updating process and services and 

supports activities. 

Place: 

In Person: National Institutes of Health, 

William H. Natcher Conference Center, 45 

Center Drive/Building 45, Conference Rooms 

E1/E2, Bethesda Campus, Bethesda, MD 

20892. 

Videocast: http://videocast.nih.gov. 

Contact Person: Ms. Lina Perez, Office of 

Autism Research Coordination, Office of the 

Director, National Institute of Mental Health, 

NIH, 6001 Executive Boulevard, Bethesda, 

MD 20892–9669, (301) 443–6040. 

IACCpublicinquiries@mail.nih.gov. 

Any member of the public interested in 

presenting oral comments to the Committee 

should notify the Contact Person listed on 

this notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations should 

submit a letter of intent, a brief description 

of the organization represented, and a 

written/electronic copy of the oral 

presentation in advance of the meeting. Only 

one representative of an organization will be 

allowed to present oral comments and 

presentations will be limited to a maximum 

of five minutes. Both printed and electronic 

copies are requested following the 

presentation for the public record. In 

addition, any interested person may submit 

written comments to 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. 

NIH has instituted stringent security 

procedures for entrance onto the NIH 

campus. All visitors must enter through the 

NIH Gateway Center. This center combines 

visitor parking, non-commercial vehicle 

inspection and visitor ID processing, all in 

one location. The NIH will process all 

visitors in vehicles or as pedestrians. You 

will be asked to submit to a vehicle or 

personal inspection and will be asked to state 

the purpose of your visit. Visitors over 15 

years of age must provide a form of 

government-issued ID such as a driver’s 

license or passport. All visitors should be 

prepared to have their personal belongings 

inspected and to go through metal detection 

inspection. 

When driving to NIH, plan some extra time 

to get through the security checkpoints. Be 

aware that visitor parking lots on the NIH 

campus can fill up quickly. The NIH campus 

is also accessible via the metro Red Line, 

Medical Center Station. The Natcher 

Conference Center is a 5-minute walk from 

the Medical Center Metro Station. 

Additional NIH campus visitor information 

is available at: http://www.nih.gov/about/ 

visitor/index.htm. Information about the 

IACC and a registration link for this meeting 

are available on the Web site: http:// 

www.iacc.hhs.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: April 13, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–9033 Filed 4–17–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control 

Special Emphasis Panel: Pilot 

Lifestyle Interventions for Pregestational 

Diabetes or Gestational Diabetes, 

Potential Extramural Project, PEP 2009– 

R–02 

Correction: This notice was published 

in the Federal Register on March 25, 

2009, Volume 74, Number 56, page 

12873. The original notice was 

published with an incorrect Potential 

Extramural Project number. 

Contact Person for More Information: 

Linda Shelton, Public Health Analyst, 

Coordinating Center for Health and 

Information Service, Office of the 

Director, CDC, 1600 Clifton Road NE., 

Mailstop E21, Atlanta, GA 30333. 

Telephone (404) 498–1194. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: April 9, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–8947 Filed 4–17–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0143] 

Risk Evaluation and Mitigation 

Strategies for Certain Opioid Drugs; 

Notice of Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to obtain input on 

developing Risk Evaluation and 

Mitigation Strategies (REMS) for certain 

opioid drugs. The REMS would be 

intended to ensure that the benefits of 

these drugs continue to outweigh 

certain risks. The agency has long been 

concerned about adverse events 

associated with this class of drug and 

has taken steps in cooperation with drug 

manufacturers to address these risks. 

We intend to use the agency’s REMS 

authority under the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) to mitigate the risks of 

these drugs. The purpose of the public 

meeting is to receive information and 

comments on this topic. 

DATES: The public meeting will be held 

on May 27 and 28, 2009, from 8 a.m. to 

5 p.m. Register to attend the meeting by 

May 15, 2009. See section III of this 

document for information on how to 

register or make an oral presentation at 

the meeting. Written or electronic 

comments will be accepted until June 

30, 2009. 

ADDRESSES: The public meeting will be 

held at the Hilton Washington, DC 

North/Gaithersburg Hotel, 620 Perry 

Pkwy., Gaithersburg, MD 20877. Submit 

written comments 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. All comments 

should be identified with the docket 

number found in brackets in the 

heading of this document. Transcripts of 

the meeting will be available for review 

at the Division of Dockets Management 

and on the Internet at http:// 

www.regulations.gov approximately 30 

days after the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Theresa (Terry) Martin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6184, 

Silver Spring, MD 20993–0002, 301– 

796–3448, FAX: 301–847–8752, or Anne 

Henig, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg 51, rm. 6176, Silver Spring, 

MD 20993–0002, 301–796–3442, FAX: 

301–847–8753, email: 

OpioidREMS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDAAA (Public Law 110–85) created 

section 505–1 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355–1). Under section 505–1 of the act, 


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