Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Notices 28883 

Kimberly S. Lane, 

Deputy Director, Office of Scientific Integrity, 

Office of the Associate Director for Science, 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–11871 Filed 5–15–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2012–0004] 

Draft Public Health Action Plan—A 

National Public Health Action Plan for 

the Detection, Prevention, and 

Management of Infertility 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of availability and 

request for public comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS) is publishing 

this notice requesting public comment 

on the draft National Public Health 

Action Plan for the Detection, 

Prevention, and Management of 

Infertility. The draft plan can be found 

at http://www.regulations.gov Docket 

No. CDC–2012–0004. Also found in the 

docket is a supporting document for 

reference, the Outline for a National 

Action Plan for the Prevention, 

Detection, and Management of 

Infertility, which was subsequently 

developed into the present Plan. 

DATES: Written comments must be 

received on or before June 15, 2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2012– 

0004, by any of the following methods: 

• Internet: Access the Federal 

eRulemaking portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Centers for Disease Control 

and Prevention, National Center for 

Chronic Disease Prevention and Health 

Promotion, Division of Reproductive 

Health, Attn: National Public Health 

Action Plan for the Detection, 

Prevention, and Management of 

Infertility, Docket No. CDC–2012–0004, 

4770 Buford Highway NE., Mailstop K– 

34, Atlanta, Georgia, 30341. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice. All 

relevant comments received will be 

posted publicly without change, 

including any personal or proprietary 

information provided. To download an 

electronic version of the plan, access 

http://www.regulations.gov. Written 

comments, identified by Docket No. 

CDC–2012–0004, will be available for 

public inspection Monday through 

Friday, except for legal holidays, from 9 

a.m. until 5 p.m., Eastern Daylight Time, 

at 2900 Woodcock Blvd., Atlanta, 

Georgia 30341. Please call ahead to 

(770) 488–5200 and ask for a 

representative from the Division of 

Reproductive Health to schedule your 

visit. Comments may also be viewed at 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Denise Jamieson, Centers for Disease 

Control and Prevention, National Center 

for Chronic Disease Prevention and 

Health Promotion, Division of 

Reproductive Health, 4770 Buford 

Highway NE., Mailstop K–34, Atlanta, 

Georgia 30341, (770)488–5200. 

SUPPLEMENTARY INFORMATION: In 2007, a 

CDC-wide ad hoc workgroup formed to 

examine the full scope of infertility 

activities across the agency. This 

workgroup conducted an assessment to 

identify gaps and opportunities in 

public health surveillance, research, 

communications, programs, and policy 

development, which led to the 2010 

publication of a white paper outlining 

the need for a national plan, with a 

public health focus, on infertility 

prevention, detection, and management. 

In consultation with many 

governmental and nongovernmental 

partners, CDC developed the National 

Public Health Action Plan for the 

Detection, Prevention and Management 

of Infertility. Addressing both male and 

female infertility, the plan outlines and 

summarizes actions needed to promote, 

preserve, and restore the ability of 

women in the United States to conceive, 

carry a pregnancy to term, and deliver 

a healthy infant. This goal extends 

beyond simply addressing the inability 

to conceive but also focuses on reducing 

the burden of impaired fecundity by 

promoting behaviors that maintain 

fertility; by promoting prevention, early 

detection, and treatment of medical 

conditions; and by reducing 

environmental and occupational threats 

to fertility. Given the public health 

focus of this action plan, promoting 

healthy pregnancy outcomes associated 

with treating and managing infertility is 

also important, as is improving the 

efficacy and safety of infertility 

treatment. 

The document is organized into three 

chapters: ‘‘Detection of Infertility,’’ 

‘‘Prevention of Infertility,’’ and 

‘‘Management of Infertility.’’ Each 

chapter addresses the topic’s public 

health importance, existing challenges, 

and opportunities for action to decrease 

the impact of infertility on the public’s 

health. The suggested opportunities 

provide federal and other government 

agencies, professional and consumer 

organizations, and other partners and 

stakeholders a foundation and platform 

to work together to decrease the burden 

of infertility in the United States. 

Dated: May 9, 2012. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2012–11774 Filed 5–15–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0009] 

Cooperative Agreement To Support 

Innovation in Vaccine Clinical Trial 

Design and Collaboration in 

Pharmacovigilance To Advance Global 

Access to Safe and Effective Vaccines 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces its 

intention to accept and consider a single 

source application for an award of a 

cooperative agreement to the World 

Health Organization (WHO) in support 

of collaborative efforts to advance 

innovative approaches to vaccine 

clinical trial design and to enhance the 

utilization of a range of 

pharmacovigilance tools as a means to 

further vaccine safety and potentially 

facilitate more rapid introduction of 

new vaccines. The goal of FDA’s Center 

for Biologics Evaluation and Research 

(CBER) is to enhance technical 

collaboration and cooperation between 

FDA, WHO, and its Member States to 

facilitate strengthening regulatory 

capacity globally. 

DATES: Important dates are as follows: 

1. The application due date is June 15, 

2012. 

2. The anticipated start date is 

September 15, 2012. 

3. The expiration date is June 16, 

2012. 

ADDRESSES: Submit the paper 

application to: Vieda Hubbard, Grants 

Management (HFA–500), 5630 Fishers 

Lane, Rockville, MD 20857, and a copy 

to Leslie Haynes, Center for Biologics 

Evaluation and Research, Office of the 

Director (HFM–30), 1401 Rockville Pike, 

Rockville, MD 20852–1448. For more 


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