[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7679-7680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02765]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0039 (Formerly 2006D-0408)]


Annual Reports for Approved Premarket Approval Applications, 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Annual Reports for Approved 
Premarket Approval Applications (PMA).'' The purpose of this guidance 
is to describe the information required to be included in an annual 
report for an approved PMA, additional information requirements that 
may be imposed by an approval order, and FDA's recommendations for the 
level of detail the applicant should provide in the annual report. It 
also identifies the steps FDA staff generally takes when reviewing 
annual reports, the resources available to assist staff in their 
reviews, and the regulatory actions they may recommend after reviewing 
annual reports.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Annual Reports for Approved Premarket Approval 
Applications (PMA)'' to the Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4613, 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. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the guidance 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: Nicole Wolanski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

I. Background

    In the Federal Register of October 26, 2006 (71 FR 62595), FDA 
announced the availability of its draft guidance entitled, ``Annual 
Reports for Approved Premarket Approval Applications (PMA),'' and 
invited interested persons to comment on the document. FDA received 
several comments, most of which sought additional clarification and 
recommendations about the level of detail and format of annual reports. 
We

[[Page 7680]]

considered all of the comments received and revised the guidance where 
appropriate.

II. Significance of Guidance

    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 annual reports for PMAs. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all Center for Device and 
Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov or from the Center for Biologics Evaluation 
and Research (CBER) at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Annual Reports for Approved Premarket Approval Applications (PMA),'' 
you may either send an email request to [email protected] to receive 
an electronic copy of the document or send a fax request to 301-847-
8149 to receive a hard copy. Please use the document number 1585 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR 814.82(a)(7) and 814.84(b) 
have been approved under OMB control number 0910-0231.
    Under section 3506(c)(2)(A) of the PRA, FDA provided a 60-day 
notice concerning the proposed collection of information set forth in 
the draft guidance (71 FR 62595, October 26, 2006). In response to the 
notice, FDA received several comments pertaining to the information 
collection.
    Comments noted that for changes previously submitted in a 
regulatory submission, requiring a rationale for each change is 
burdensome and duplicative because FDA already has this information. In 
response to this comment, FDA modified the guidance to request only 
limited information for changes that were submitted as either a PMA 
supplement or 30-day notice, including supplement number and the status 
of the document.
    Comments requested clarification of the type of information, data, 
and level of detail that need to be provided. In response, FDA removed 
columns from the proposed ``Changes Table'' in the guidance, including 
columns for validation testing, implementation date, approval date, and 
risk analysis.
    As a result of modifications made to the guidance in response to 
comments, the guidance no longer imposes an information collection 
burden additional to that previously approved in OMB control number 
0910-0231. FDA is therefore no longer requesting approval of an 
additional information collection.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is necessary to 
send only one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02765 Filed 2-7-14; 8:45 am]
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