Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions, 7678-7679 [2014-02753]

Download as PDF 7678 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Notices authorizes FDA to conduct research relating to health information. FDA’s Center for Devices and Radiological Health (CDRH) carries out FDA’s regulatory responsibilities regarding medical devices and radiological products. CDRH must be able to effectively communicate risk to health care practitioners, patients, caregivers, and consumers when there is a real or suspected threat to the public’s health. CDRH uses safety communications to transmit information concerning these risks to user communities. Safety communications are released and available to organizations such as hospitals, nursing homes, hospices, home health care agencies, manufacturers, retail pharmacies, and other health care providers, as well as patients, caregivers, consumers, and patient advocacy groups. Through a process for identifying and addressing postmarket safety issues related to regulated products, CDRH determines when to release safety communications. FDA seeks to evaluate the clarity, timeliness, and impact of safety communications by surveying a sample of recipients to determine the impact of safety communications on the knowledge of the recipients. Understanding how the target audiences view these publications will aid in determining what, if any, changes should be considered in their content, format, and method of dissemination. The collection of this data is an important step in determining how well CDRH is communicating risk. The results from this survey will emphasize the quality of the safety communications and customer satisfaction. This will enable us to better serve the public by improving the effectiveness of safety communications. We updated the title of the survey from ‘‘FDA Public Health Notification Readership Survey’’ to ‘‘FDA Safety Communication Readership Survey’’ to accurately reflect the information that is being collected. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Public Health Notification Readership Survey ..................... 300 3 900 0.17 (10 minutes) 153 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on the history of the FDA Safety Communication program, it is estimated that an average of three collections will be conducted per year. The average burden of response time is estimated at 10 minutes per survey. This was derived by CDRH staff completing the survey. Dated: February 3, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02752 Filed 2–7–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1393] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget SUMMARY: VerDate Mar<15>2010 19:25 Feb 07, 2014 Jkt 232001 (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 12, 2014. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0233. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions—21 CFR Part 60 (OMB Control Number 0910–0233)—Extension FDA’s patent extension activities are conducted under the authority of the Drug Price Competition and Patent Term Restoration Act of 1984 (21 U.S.C. 355(j)) and the Generic Animal Drug PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 and Patent Term Restoration Act of 1988 (35 U.S.C. 156). New human drug, animal drug, human biological, medical device, food additive, or color additive products regulated by the FDA must undergo FDA safety, or safety and effectiveness, review before marketing is permitted. Where the product is covered by a patent, part of the patent’s term may be consumed during this review, which diminishes the value of the patent. In enacting the Drug Price Competition and Patent Term Restoration Act of 1984 and the Generic Animal Drug and Patent Term Restoration Act of 1988, Congress sought to encourage development of new, safer, and more effective medical and food additive products. It did so by authorizing the U.S. Patent and Trademark Office (PTO) to extend the patent term by a portion of the time during which FDA’s safety and effectiveness review prevented marketing of the product. The length of the patent term extension is generally limited to a maximum of 5 years, and is calculated by PTO based on a statutory formula. When a patent holder submits an application for patent term extension to PTO, PTO requests information from FDA, including the length of the regulatory review period for the patented product. If PTO concludes that the product is eligible for patent term extension, FDA publishes a notice that describes the length of the regulatory review period and the dates E:\FR\FM\10FEN1.SGM 10FEN1 7679 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Notices used to calculate that period. Interested parties may request, under § 60.24 (21 CFR 60.24), revision of the length of the regulatory review period, or may petition under § 60.30 (21 CFR 60.30) to reduce the regulatory review period by any time where marketing approval was not pursued with ‘‘due diligence.’’ The statute defines due diligence as ‘‘that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.’’ As provided in § 60.30(c), a due diligence petition ‘‘shall set forth sufficient facts, including dates if possible, to merit an investigation by FDA of whether the applicant acted with due diligence.’’ Upon receipt of a due diligence petition, FDA reviews the petition and evaluates whether any change in the regulatory review period is necessary. If so, the corrected regulatory review period is published in the Federal Register. A due diligence petitioner not satisfied with FDA’s decision regarding the petition may, under § 60.40 (21 CFR 60.40), request an informal hearing for reconsideration of the due diligence determination. Petitioners are likely to include persons or organizations having knowledge that FDA’s marketing permission for that product was not actively pursued throughout the regulatory review period. The information collection for which an extension of approval is being sought is the use of the statutorily created due diligence petition. Since 1992, 15 requests for revision of the regulatory review period have been submitted under § 60.24(a). For 2010, 2011, and 2012, a total of three requests have been submitted under § 60.24(a). During that same time period, there have been no requests under §§ 60.30 and 60.40; however, for purposes of this information collection approval, we are estimating that we may receive one submission annually. In the Federal Register of November 14, 2013 (78 FR 68454), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR Section 60.24(a) ................................................................................ 60.30 .................................................................................... 60.40 .................................................................................... 1 1 1 Average burden per response Total annual responses 1 1 1 1 1 1 Total .............................................................................. 1 There BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [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 Food and Drug Administration, HHS. Notice. 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 SUMMARY: VerDate Mar<15>2010 19:25 Feb 07, 2014 Jkt 232001 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 DATES: Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES 160 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. [FR Doc. 2014–02753 Filed 2–7–14; 8:45 am] ACTION: 100 50 10 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 4, 2014. Leslie Kux, Assistant Commissioner for Policy. AGENCY: 100 50 10 Total hours PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 for information on electronic access to the guidance. Submit electronic comments on the guidance to https://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 E:\FR\FM\10FEN1.SGM 10FEN1

Agencies

[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7678-7679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02753]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1393]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Patent Term
Restoration, Due Diligence Petitions, Filing, Format, and Content of
Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
12, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0233.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Patent Term Restoration, Due Diligence Petitions, Filing, Format, and
Content of Petitions--21 CFR Part 60 (OMB Control Number 0910-0233)--
Extension

FDA's patent extension activities are conducted under the authority
of the Drug Price Competition and Patent Term Restoration Act of 1984
(21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term
Restoration Act of 1988 (35 U.S.C. 156). New human drug, animal drug,
human biological, medical device, food additive, or color additive
products regulated by the FDA must undergo FDA safety, or safety and
effectiveness, review before marketing is permitted. Where the product
is covered by a patent, part of the patent's term may be consumed
during this review, which diminishes the value of the patent. In
enacting the Drug Price Competition and Patent Term Restoration Act of
1984 and the Generic Animal Drug and Patent Term Restoration Act of
1988, Congress sought to encourage development of new, safer, and more
effective medical and food additive products. It did so by authorizing
the U.S. Patent and Trademark Office (PTO) to extend the patent term by
a portion of the time during which FDA's safety and effectiveness
review prevented marketing of the product. The length of the patent
term extension is generally limited to a maximum of 5 years, and is
calculated by PTO based on a statutory formula. When a patent holder
submits an application for patent term extension to PTO, PTO requests
information from FDA, including the length of the regulatory review
period for the patented product. If PTO concludes that the product is
eligible for patent term extension, FDA publishes a notice that
describes the length of the regulatory review period and the dates

[[Page 7679]]

used to calculate that period. Interested parties may request, under
Sec. 60.24 (21 CFR 60.24), revision of the length of the regulatory
review period, or may petition under Sec. 60.30 (21 CFR 60.30) to
reduce the regulatory review period by any time where marketing
approval was not pursued with ``due diligence.''
The statute defines due diligence as ``that degree of attention,
continuous directed effort, and timeliness as may reasonably be
expected from, and are ordinarily exercised by, a person during a
regulatory review period.'' As provided in Sec. 60.30(c), a due
diligence petition ``shall set forth sufficient facts, including dates
if possible, to merit an investigation by FDA of whether the applicant
acted with due diligence.'' Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates whether any change in the
regulatory review period is necessary. If so, the corrected regulatory
review period is published in the Federal Register. A due diligence
petitioner not satisfied with FDA's decision regarding the petition
may, under Sec. 60.40 (21 CFR 60.40), request an informal hearing for
reconsideration of the due diligence determination. Petitioners are
likely to include persons or organizations having knowledge that FDA's
marketing permission for that product was not actively pursued
throughout the regulatory review period. The information collection for
which an extension of approval is being sought is the use of the
statutorily created due diligence petition.
Since 1992, 15 requests for revision of the regulatory review
period have been submitted under Sec. 60.24(a). For 2010, 2011, and
2012, a total of three requests have been submitted under Sec.
60.24(a). During that same time period, there have been no requests
under Sec. Sec. 60.30 and 60.40; however, for purposes of this
information collection approval, we are estimating that we may receive
one submission annually.
In the Federal Register of November 14, 2013 (78 FR 68454), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this information collection as follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
60.24(a)........................ 1 1 1 100 100
60.30........................... 1 1 1 50 50
60.40........................... 1 1 1 10 10
-------------------------------------------------------------------------------
Total....................... 160
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02753 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P

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