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] 

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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; 

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Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices 18227 

• To assess signals of serious risk 

related to the use of the drug; or 

• To identify an unexpected serious 

risk when available data indicates the 

potential for a serious risk. 

This guidance provides information 

on the implementation of new section 

505(o)(3) of the FD&C Act. The guidance 

also describes which types of 

postmarketing studies and clinical trials 

will be required (PMRs) under section 

505(o)(3) and which types will be 

agreed-upon commitments because they 

do not meet the statutory criteria for 

required studies and trials (PMCs). 

In the Federal Register of July 15, 

2009 (74 FR 34358), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Postmarketing Studies 

and Clinical Trials—Implementation of 

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

Drug, and Cosmetic Act.’’ The notice 

gave interested persons the opportunity 

to comment by October 13, 2009. The 

draft guidance was revised in response 

to comments submitted to the docket 

requesting that the guidance clearly 

distinguish PMRs required under 

section 505(o)(3) of the FD&C Act from 

risk evaluation and mitigation strategies. 

The revisions also provide additional 

detail in the examples of PMRs and 

PMCs and clarify reporting 

requirements. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on the implementation 

of section 901 of FDAAA on 

postmarketing studies and clinical 

trials. 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) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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 provides information 

on the implementation of section 901 of 

FDAAA. The collections of information 

requested in the draft guidance would 

be submitted under 21 CFR 314.80, 

314.81, and 601.70. These collections of 

information 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) and 

are approved under OMB control 

numbers 0910–0230, 0910–0001, and 

0910–0338. Section VI of the guidance 

refers to procedures in the guidance 

entitled ‘‘Formal Dispute Resolution: 

Appeals Above the Division Level,’’ 

which contains collections of 

information approved under OMB 

control number 0910–0430. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: March 28, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7707 Filed 3–31–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0066] 

Molecular and Clinical Genetics Panel 

of the Medical Devices Advisory 

Committee; Notice of Meeting; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

May 2, 2011, the comment period for 

the notice announcing a meeting of the 

Molecular and Clinical Genetics Panel 

(the panel) of the Medical Devices 

Advisory Committee that published in 

the Federal Register of February 7, 2011 

(76 FR 6623). In the notice, FDA 

requested public comment regarding the 

March 8 and 9, 2011, meeting of the 

panel to discuss and make 

recommendations on scientific issues 

concerning direct to consumer (DTC) 

genetic tests that make medical claims. 

FDA is reopening the comment period 

to update comments and to receive any 

new information. 

DATES: Submit either electronic or 

written comments and information by 

May 2, 2011. 

ADDRESSES: Submit electronic 

comments or information 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Mansfield, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave, Bldg. 66, rm. 5676, Silver Spring, 

MD 20993–0002, 301–796–4664. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 7, 

2011 (76 FR 6623), FDA published a 

notice announcing a meeting of the 

Molecular and Clinical Genetics Panel 

of the Medical Devices Advisory 

Committee, and the opening of a public 

docket to seek input and comments 

from interested stakeholders to discuss 

scientific issues concerning DTC tests. 

Interested persons were given until 

March 1, 2011, to submit comments. 

II. Request for Comments 

Following publication of the February 

7, 2011, notice, FDA received requests 

to allow interested persons additional 

time to comment. The requesters 

asserted that the initial time period was 

insufficient to allow potential 

respondents to thoroughly evaluate and 

assess pertinent issues. The Agency has 

considered the requests and is 

reopening the comment period until 

May 2, 2011. 

III. How to Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding the meeting. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

Dated: March 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7708 Filed 3–31–11; 8:45 am] 

BILLING CODE 4160–01–P 

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