Document ID: FDA-2011-N-0813-0001
Agency: fda
Document Type: Notice
Title: Quantitative Summary of the Benefits and Risks of Prescription Drugs - A Literature Review; Availability
Posted Date: 2011-12-13T05:00Z

[Federal Register Volume 76, Number 239 (Tuesday, December 13, 2011)]
[Notices]
[Page 77543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31931]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0813]

Quantitative Summary of the Benefits and Risks of Prescription 
Drugs: A Literature Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft report entitled ``Quantitative Summary of the 
Benefits and Risks of Prescription Drugs: A Literature Review'' 
(literature review report). A literature review was conducted to 
address a requirement of the Patient Protection and Affordable Care Act 
(Affordable Care Act). FDA is publishing the literature review report 
to allow the public to provide comment on the report as it relates to 
the Affordable Care Act.

DATES: Submit either electronic or written comments on the literature 
review report by February 13, 2012.

ADDRESSES: You may submit comments, identified by Docket No. 2011-N-
0813, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: (301) 827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Helen Sullivan, Office of Prescription 
Drug Promotion, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3263, Silver Spring, MD 20993-0002, (301) 796-1200, 
email: helen.sullivan@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft report entitled 
``Quantitative Summary of the Benefits and Risks of Prescription Drugs: 
A Literature Review.'' A literature review was conducted to address 
section 3507 \1\ of the Affordable Care Act (see http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf). Section 3507(a) 
requires the Secretary of Health and Human Services (HHS), acting 
through the Commissioner of Food and Drugs, to determine whether the 
addition of quantitative summaries of the benefits and risks of 
prescription drugs in standardized format (e.g., similar to ``Drug 
Facts'' on over-the-counter products) to the promotional labeling or 
print advertising of such drugs would ``improve health care 
decisionmaking by clinicians and patients and consumers'' (section 
3507(a), Pub. L. 111-148, 124 Stat. 530). In making this determination, 
the law directs FDA to ``review all available scientific evidence and 
research on decisionmaking and social and cognitive psychology'' 
(section 3507(b), Pub. L. 111-148, 124 Stat. 530), and to consult 
manufacturers and consumers, experts in health literacy, 
representatives of racial and ethnic minorities, and experts in women's 
and pediatric health.
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    \1\ Public Law, 111-148, 124 Stat. 119, 530 (codified at note 
following 21 U.S.C. 352).
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    To fulfill this requirement, FDA has commissioned an objective 
review of science-based studies related to the communication of 
quantitative benefit and risk information. FDA is making available the 
literature review report and is providing a comment period for 
interested parties to comment on the literature review report as it 
relates to section 3507 of the Affordable Care Act.

II. Electronic Access

    Persons with access to the Internet may obtain the literature 
review report at http://www.regulations.gov.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
literature review report. 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 and labeled ``ATTN: Literature Review.'' 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
    All submissions received must include the agency name and docket 
number. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided.

    Dated: December 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31931 Filed 12-12-11; 8:45 am]
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