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Notice

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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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:

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.
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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.

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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.

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.

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Dated: December 8, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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Footnotes

1.  Public Law, 111-148, 124 Stat. 119, 530 (codified at note following 21 U.S.C. 352).

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[FR Doc. 2011-31931 Filed 12-12-11; 8:45 am]

BILLING CODE 4160-01-P