Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices 18225 

lawyers as specialist is child welfare, 

develops and implements child 

representation research and 

demonstration projects to promote 

evidence-based, evidence-informed 

practice improvements and effective 

child representation, establishes and 

maintains a national information 

sharing network to disseminate 

information on promising practices; 

evaluates the impact of selected projects 

implementing the child representation 

models on outcomes for children and 

families who have competent and 

effective child representation, and 

identifies barriers and recommends 

need changes in laws, policies, 

procedures and/or practice. The 

supplemental funds will be used to 

provide additional training, technical 

assistance, and support to each research 

and demonstration site to fully 

implement and maintain rigorous onsite and cross-site evaluation plans. 

FOR FURTHER INFORMATION CONTACT: Gail 

Collins, Children’s Bureau, 1250 

Maryland Avenue, SW., Washington, 

DC 20047. Telephone: 202–205–8552, 

e-mail: gail.collins@acf.hhs.gov. 

Dated: March 23, 2011. 

Bryan Samuels, 

Commissioner, Administration on Children, 

Youth and Families. 

[FR Doc. 2011–7648 Filed 3–31–11; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Request for Public Comment on 

Proposed Funding Opportunity 

Announcement for Special Initiative 

Concerning the Assets for 

Independence Program 

AGENCY: Office of Community Services, 

ACF, HHS. 

ACTION: Request for Public Comment. 

C.F.D.A. Number: 93.602 

Statutory Authority: The Assets for 

Independence Act (Title IV of the 

Community Opportunities, Accountability, 

and Training and Educational Services Act of 

1998, as amended, Pub. L. 105–285, 42 U.S.C. 

604 note) authorizes the Department of 

Health and Human Services to award grants 

to support Assets for Independence (AFI) 

projects and to research and evaluate the 

effectiveness of the AFI program and 

Individual Development Accounts (IDAs). 

SUMMARY: In FY 2011, the Office of 

Community Services (OCS) will 

coordinate with the Administration on 

Native Americans (ANA) to implement 

the Native Asset Building Initiative, 

through which the two offices will 

support Tribes and Native organizations 

in planning and implementing 

comprehensive asset-building projects. 

The initiative will feature special grants 

through the Assets for Independence 

(AFI) program. These grants will be in 

addition to the annual AFI grants that 

OCS will award in FY 2011. In contrast 

to the annual awards, though, the 

eligibility criteria to be listed for these 

AFI grants in the ‘‘Native Asset Building 

Initiative’’ will vary from the annual AFI 

awards’ eligibility criteria. This is 

because the criteria used to determine 

eligibility for these special initiative 

awards will be more consistent with 

those used to determine eligibility in the 

ANA grant program with which OCS is 

coordinating. Consequently, the 

eligibility for the special AFI grants will 

be limited to Native 501(c)(3) nonprofits serving Native Americans; 

Federally recognized Tribal 

governments or Alaska Native Villages, 

as defined in the Alaska Native Claims 

Settlement Act, that are joint applicants 

with a 501(c)(3) Native non-profit 

organization; and Native non-profit 

organizations designated by the 

Secretary of the Treasury as Community 

Development Financial Institutions and 

Native non-profit credit unions 

designated by the National Credit Union 

Administration as low-income credit 

unions that demonstrate a collaborative 

relationship with a local community 

based organization whose activities are 

designed to address poverty and the 

needs of community members for 

economic independence and stability. 

Other entities will not be eligible for 

awards under this initiative, but will 

continue to be eligible for awards under 

the annual AFI funding opportunity 

announcement that was published 

issued for FY 2011 through FY 2013 on 

February 24, 2011 on http:// 

www.acf.hhs.gov/grants/open/foa/view/ 

HHS-2011-ACF-OCS-EI-0137. 

It is estimated that OCS will award up 

to 10 AFI program grants under Native 

Asset Building Initiative, with overall 

funding of approximately $2,500,000 

toward the initiative. It is anticipated 

that each recipient of these special AFI 

grants will also receive a separate ANA 

award for their project. 

In addition to these special AFI 

awards, we estimate that $15,000,000 in 

grants will be awarded in FY 2011 

under the annual AFI funding 

opportunity announcement published 

on February 24, 2011. 

Proposed Funding Opportunity 

Announcement; Native Asset Building 

Initiative 

In FY 2011, OCS will coordinate with 

the Administration on Native 

Americans (ANA) on the Native Asset 

Building Initiative to support Tribes and 

Native organizations in planning and 

implementing comprehensive asset 

building projects. OCS and ANA are 

providing this support through a joint 

funding opportunity and training and 

technical assistance. 

The OCS component of the joint 

funding opportunity will feature special 

Assets for Independence (AFI) program 

grants the eligibility for which will be 

limited to entities that are eligible for 

ANA grants. Therefore, eligibility for the 

special AFI grants will be limited to 

Native 501(c)(3) non-profits serving 

Native Americans; Federally recognized 

Tribal governments or Alaska Native 

Villages, as defined in the Alaska Native 

Claims Settlement Act, that are joint 

applicants with a 501(c)(3) Native nonprofit organization; Native non-profit 

organizations designated by the 

Secretary of the Treasury as Community 

Development Financial Institutions and 

Native non-profit credit unions 

designated by the National Credit Union 

Administration as low-income credit 

unions that demonstrate a collaborative 

relationship with a local communitybased organization whose activities are 

designed to address poverty and the 

needs of community members for 

economic independence and stability. 

Other entities will not be eligible to 

submit applications for the AFI grants 

under the Native Asset Building 

Initiative. It is estimated that OCS will 

award up to ten AFI program grants 

under the initiative, with overall 

funding of approximately $2,500,000. 

The ANA component of the Native 

Asset Building Initiative will feature a 

new funding opportunity through the 

Social and Economic Development 

Strategies (SEDS) program as well. The 

SEDS grants will provide funding for 

each project’s operational and staffing 

costs, as well as support for financial 

literacy education training, capacity 

building, and other asset building 

activities. 

The OCS AFI grants will provide 

funding to support the provision of 

Individual Development Accounts 

(IDA), or matched savings accounts, 

component of each selected applicant’s 

comprehensive asset building project. 

The AFI grantees will also provide 

funding to support limited 

administrative costs related to the IDA 

component. AFI is a demonstration of 

the use of IDAs and related strategies 

mstockstill on DSKH9S0YB1PROD with NOTICES

18226 Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices 

using an asset-based approach for 

assisting individuals and families with 

low incomes out of poverty. The 

program supports grantee organizations 

that provide financial literacy education 

and other training to families, along 

with access to IDAs. Every dollar in 

savings deposited into an IDA by a 

participant will be matched with AFI 

grant funds and non-federal funds. The 

program promotes savings and enables 

participants to acquire an economic 

asset that will appreciate over the longterm. Participants use their IDA savings 

to acquire a first home, capitalize a 

small business, or enroll in 

postsecondary education or training. 

The Native Asset Building Initiative is 

designed to create synergies between the 

SEDS program and the AFI program, 

and to provide enhanced funding 

opportunities for Native communities. 

OCS and ANA anticipate that the Native 

Asset Building Initiative funding 

opportunity announcement will be 

published in April 2011. Upon 

publication, the Native Asset Building 

Initiative funding opportunity 

announcement will be made available at 

http://www.Grants.gov and at ACF 

Funding Opportunities http:// 

www.acf.hhs.gov/grants/index.html. 

Information on the planned 

announcement may now be accessed at 

the HHS Grants Forecast Web site at 

http://www.acf.hhs.gov/ 

hhsgrantsforecast/. 

OCS will publish a synopsis of 

comments received as a result of this 

notice, along with the agency’s 

responses. 

DATES: The deadline for receipt of 

comments is 30 days from the date of 

publication of this notice in the Federal 

Register. 

ADDRESSES: Comments in response to 

this notice should be addressed to James 

Gatz, Manager, Assets for Independence 

Program, Office of Community Services, 

370 L’Enfant Promenade, SW., Mailstop 

Aerospace 5–West, Washington, DC 

20447. Comments will be available for 

inspection by members of the public at 

the Office of Community Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Medina, Program Specialist, 

(866) 778–6037. 

Dated: March 23, 2011. 

Yolanda Butler, 

Acting Director, Office of Community 

Services. 

[FR Doc. 2011–7649 Filed 3–31–11; 8:45 am] 

BILLING CODE 4184–26–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0283] 

Guidance for Industry on 

Postmarketing Studies and Clinical 

Trials—Implementation of Section 

505(o)(3) of the Federal Food, Drug, 

and Cosmetic Act; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Postmarketing Studies and 

Clinical Trials—Implementation of 

Section 505(o)(3) of the Federal Food, 

Drug, and Cosmetic Act.’’ The Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) added new provisions 

to the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) authorizing FDA to 

require certain postmarketing studies 

and clinical trials for prescription drugs 

approved under the FD&C Act and 

biological products approved under the 

Public Health Service Act (the PHS Act). 

This guidance provides information on 

the implementation of the new 

provisions and a description of the 

types of postmarketing studies and 

clinical trials that will generally be 

required under the new legislation 

(postmarketing requirements (PMRs)) 

and the types that will generally be 

agreed-upon commitments 

(postmarketing commitments (PMCs)) 

because they do not meet the new 

statutory criteria for required 

postmarketing studies and clinical 

trials. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this 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, suite 200N, 

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 the office in 

processing your requests. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Dickinson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–5400; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Postmarketing Studies and Clinical 

Trials—Implementation of Section 

505(o)(3) of the Federal Food, Drug, and 

Cosmetic Act.’’ In the past, FDA has 

used the term ‘‘PMC’’ to refer to studies 

(including clinical trials), conducted by 

an applicant after FDA has approved a 

drug for marketing or licensing, that 

were intended to further refine the 

safety, efficacy, or optimal use of a 

product, or to ensure consistency and 

reliability of product quality. These 

commitments were either agreed upon 

by FDA and the applicant or, in certain 

circumstances, required by FDA. Prior 

to the passage of FDAAA, FDA required 

PMCs in the following situations: 

• Subpart H and subpart E 

accelerated approvals, which require 

postmarketing studies to demonstrate 

clinical benefit (21 CFR 314.510 and 

601.41); 

• Deferred pediatric studies, where 

studies are required under the Pediatric 

Research Equity Act (section 505, FD&C 

Act); and 

• Animal Efficacy Rule approvals, 

where studies to demonstrate safety and 

efficacy in humans are required at the 

time of use (21 CFR 314.610(b)(1) and 

601.91(b)(1)). 

Title IX, section 901 of FDAAA (Pub. 

L. 110–85) amended the FD&C Act by 

adding new section 505(o) (21 U.S.C. 

355(o)). Section 505(o)(3) of the FD&C 

Act authorizes FDA to require certain 

postmarketing studies or clinical trials 

for prescription drugs approved under 

section 505(b) of the FD&C Act and 

biological products approved under 

section 351 of the PHS Act (42 U.S.C. 

262). Section 505(o)(3)(B) of the FD&C 

Act states that postmarketing studies 

and clinical trials may be required for 

one of three purposes: 

• To assess a known serious risk 

related to the use of the drug; 

mstockstill on DSKH9S0YB1PROD with NOTICES