10908 Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices 

the District of Columbia. As funding 

allows, CDC’s strategic plan calls for 

expanding the program to health 

departments in all U.S. States and 

territories. CDC works with HDSP 

program awardees to implement and 

evaluate evidence-based public health 

prevention and control strategies that 

address risk factors and reduce 

disparities, disease, disability, and 

death from heart disease and stroke. 

The DHDSP MIS provides a 

standardized, electronic interface for the 

collection of progress and activity 

information from HDSP awardees. The 

information collection includes work 

plans, objectives, partners, data sources, 

and policy and environmental 

assessments. The MIS produces both 

State-specific and aggregate reports that 

are used for performance monitoring, 

program evaluation, and technical 

assistance. The monitoring and 

evaluation plan for HDSP awardees is 

part of an overall initiative within CDC’s 

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP) to promote more efficient 

ways of using resources and achieving 

greater health impact. 

CDC will continue to use the 

information collected through the 

DHDSP MIS to identify State-specific 

heart disease and stroke prevention 

priorities and objectives, and to describe 

the impact and reach of program 

interventions. Respondents will be 42 

health departments in 41 States and the 

District of Columbia (DC). Respondents 

will continue to submit their progress 

and activity information to CDC semiannually. There are no costs to 

respondents other than their time. The 

total estimated annualized burden hours 

are 504. 

Estimated annualized burden hours 

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

State-Based Heart Disease and Stroke Prevention Programs ................................................... 42 2 6 

Dated: February 22, 2011. 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–4330 Filed 2–25–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Maternal 

Vitamin D Status and Preterm Birth, 

DP11–002, Initial Review 

Correction: The notice was published 

in the Federal Register on December 17, 

2010, Volume 75, Number 242, Page 

78999. The time and date should read 

as follows: 

Time and Date: 11 a.m.–5 p.m., April 12, 

2011 (Closed). 

Contact Person for More Information: 

Donald Blackman, Ph.D., Scientific 

Review Officer, CDC, National Center 

for Chronic Disease Prevention and 

Health Promotion, Office of the Director, 

Extramural Research Program Office, 

4770 Buford Highway, NE., Mailstop K– 

92, Atlanta, Georgia 30341, Telephone: 

(770) 488–3023, E-mail: DBY7@cdc.gov. 

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 the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 17, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–4305 Filed 2–25–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0074] 

Draft Guidance for Industry on 

Medication Guides—Distribution 

Requirements and Inclusion of 

Medication Guides in Risk Evaluation 

and Mitigation Strategies; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Medication Guides— 

Distribution Requirements and 

Inclusion in Risk Evaluation and 

Mitigation Strategies (REMS).’’ This 

draft guidance addresses two topics 

pertaining to Medication Guides for 

drug and biological products. First, the 

draft guidance addresses when FDA 

intends to exercise enforcement 

discretion regarding dispensing 

requirements for Medication Guides that 

must be distributed with a drug or 

biological product dispensed to a 

healthcare professional for 

administration to a patient instead of 

being dispensed directly to the patient 

for self-administration or to the patient’s 

caregiver for administration to the 

patient. Second, the draft guidance 

addresses when a Medication Guide 

will be required as part of a REMS. The 

draft guidance is intended to answer 

questions that have arisen concerning 

these topics. 

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 

either electronic or written comments 

on the draft guidance by May 31, 2011. 

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 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. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 


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