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availability of a draft guidance for 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draft guidance was revised in response 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] 

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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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