81_FR_91098 81 FR 90857 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act

81 FR 90857 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 241 (December 15, 2016)

Page Range90857-90858
FR Document2016-30113

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.

Federal Register, Volume 81 Issue 241 (Thursday, December 15, 2016) 
[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90857-90858]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0795]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Third-Party Review Under the Food and Drug Administration Modernization 
Act

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 January 
17, 2017.

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 0910-0375. 
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, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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.

Medical Devices; Third-Party Review Under the Food and Drug 
Administration Modernization Act--OMB Control Number 0910-0375--
Extension

    Section 210 of the Food and Drug Administration Modernization Act 
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360m), directing FDA to accredit persons in the private 
sector to review certain premarket notifications (510(k)s). 
Participation in this third-party review program by accredited persons 
is entirely voluntary. A third party wishing to participate will submit 
a request for accreditation to FDA. Accredited third-party reviewers 
have the ability to review a manufacturer's 510(k) submission for 
selected devices. After reviewing a submission, the reviewer will 
forward a copy of the 510(k) submission, along with the reviewer's 
documented review and recommendation, to FDA. Third-party reviewers 
should maintain records of their 510(k) reviews and a copy of the 
510(k) for a reasonable period of time, usually a period of 3 years.
    This information collection will allow FDA to continue to implement 
the accredited person review program established by FDAMA and improve 
the efficiency of 510(k) review for low- to moderate-risk devices. 
Respondents to this information collection are businesses or other for-
profit organizations.
    FDA receives an average of one application for accreditation for 
third-party review per year. According to FDA's data, the number of 
510(k)s submitted for third-party review is approximately 260 annually, 
which is 26 annual reviews per each of the 10 accredited reviewers. 
Third-party reviewers are required to keep records of their review of 
each submission.
    In the Federal Register of July 8, 2016 (81 FR 44627), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Requests for accreditation......               1               1               1              24              24
510(k) reviews conducted by                   10              26             260              40          10,400
 accredited third parties.......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,424
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews.....................................................              10               26              260               10            2,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 90858]]

    Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30113 Filed 12-14-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices 90857 IV. Electronic Access ACTION: Notice. review certain premarket notifications Persons with access to the Internet (510(k)s). Participation in this third- SUMMARY: The Food and Drug party review program by accredited may obtain the guidance at http:// Administration (FDA) is announcing www.fda.gov/Drugs/Guidance persons is entirely voluntary. A third that a proposed collection of ComplianceRegulatoryInformation/ information has been submitted to the party wishing to participate will submit Guidances/default.htm, http:// Office of Management and Budget a request for accreditation to FDA. www.fda.gov/BiologicsBloodVaccines/ (OMB) for review and clearance under Accredited third-party reviewers have GuidanceComplianceRegulatory the Paperwork Reduction Act of 1995. the ability to review a manufacturer’s Information/Guidances/default.htm, 510(k) submission for selected devices. DATES: Fax written comments on the http://www.fda.gov/MedicalDevices/ After reviewing a submission, the collection of information by January 17, DeviceRegulationandGuidance/ reviewer will forward a copy of the 2017. GuidanceDocuments/default.htm, 510(k) submission, along with the http://www.fda.gov/ScienceResearch/ ADDRESSES: To ensure that comments on the information collection are received, reviewer’s documented review and SpecialTopics/RunningClinicalTrials/ recommendation, to FDA. Third-party GuidancesInformationSheetsandNotices OMB recommends that written comments be faxed to the Office of reviewers should maintain records of /ucm219433.htm, http://www.fda.gov/ their 510(k) reviews and a copy of the ScienceResearch/SpecialTopics/ Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 510(k) for a reasonable period of time, RunningClinicalTrials/Proposed 202–395–7285, or emailed to oira_ usually a period of 3 years. RegulationsandDraftGuidances/ default.htm, http://www.hhs.gov/ohrp/ submission@omb.eop.gov. All This information collection will allow newsroom/rfc/index.html, or http:// comments should be identified with the FDA to continue to implement the www.regulations.gov. OMB control number 0910–0375. Also accredited person review program include the FDA docket number found established by FDAMA and improve the Leslie Kux, in brackets in the heading of this efficiency of 510(k) review for low- to Assistant Commissioner for Policy, Food and document. Drug Administration. moderate-risk devices. Respondents to FOR FURTHER INFORMATION CONTACT: FDA this information collection are Karen B. DeSalvo, PRA Staff, Office of Operations, Food businesses or other for-profit Acting Assistant Secretary for Health, and Drug Administration, Three White organizations. Department of Health and Human Services. Flint North, 10A63, 11601 Landsdown [FR Doc. 2016–30146 Filed 12–14–16; 8:45 am] FDA receives an average of one St., North Bethesda, MD 20852, BILLING CODE 4164–01–P application for accreditation for third- PRAStaff@fda.hhs.gov. party review per year. According to SUPPLEMENTARY INFORMATION: In FDA’s data, the number of 510(k)s DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA submitted for third-party review is HUMAN SERVICES has submitted the following proposed collection of information to OMB for approximately 260 annually, which is review and clearance. 26 annual reviews per each of the 10 Food and Drug Administration accredited reviewers. Third-party [Docket No. FDA–2013–N–0795] Medical Devices; Third-Party Review reviewers are required to keep records Under the Food and Drug of their review of each submission. Agency Information Collection Administration Modernization Act— Activities; Submission for Office of OMB Control Number 0910–0375— In the Federal Register of July 8, 2016 Management and Budget Review; Extension (81 FR 44627), FDA published a 60-day Comment Request; Medical Devices; notice requesting public comment on Section 210 of the Food and Drug the proposed collection of information. Third-Party Review Under the Food Administration Modernization Act and Drug Administration FDA estimates the burden of this (FDAMA) established section 523 of the Modernization Act collection of information as follows: Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, (21 U.S.C. 360m), directing FDA to HHS. accredit persons in the private sector to TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Activity responses per burden per Total hours respondents responses respondent response Requests for accreditation ................................................... 1 1 1 24 24 510(k) reviews conducted by accredited third parties ......... 10 26 260 40 10,400 Total .............................................................................. ........................ ........................ ........................ ........................ 10,424 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 rmajette on DSK2TPTVN1PROD with NOTICES Number of Average Number of Total annual Activity records per burden per Total hours recordkeepers records recordkeeper recordkeeping 510(k) reviews ...................................................................... 10 26 260 10 2,600 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 15:19 Dec 14, 2016 Jkt 241001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\15DEN1.SGM 15DEN1

90858 Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices Dated: December 12, 2016. hereby given of a meeting of the DEPARTMENT OF HEALTH AND Leslie Kux, National Advisory Council for HUMAN SERVICES Associate Commissioner for Policy. Biomedical Imaging and Bioengineering. [FR Doc. 2016–30113 Filed 12–14–16; 8:45 am] The meeting will be open to the National Institutes of Health BILLING CODE 4164–01–P public as indicated below, with Center for Scientific Review; Notice of attendance limited to space available. Closed Meeting Individuals who plan to attend and DEPARTMENT OF HEALTH AND need special assistance, such as sign Pursuant to section 10(d) of the HUMAN SERVICES language interpretation or other Federal Advisory Committee Act, as reasonable accommodations, should amended (5 U.S.C. App.), notice is National Institutes of Health notify the Contact Person listed below hereby given of the following meeting. in advance of the meeting. The meeting will be closed to the National Institute of Biomedical public in accordance with the Imaging and Bioengineering; Notice of The meeting will be closed to the provisions set forth in sections Closed Meeting public in accordance with the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., provisions set forth in sections Pursuant to section 10(d) of the as amended. The grant applications and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Federal Advisory Committee Act, as the discussions could disclose as amended. The grant applications amended (5 U.S.C. App.), notice is confidential trade secrets or commercial and/or contract proposals and the hereby given of the following meeting. property such as patentable material, discussions could disclose confidential The meeting will be closed to the and personal information concerning trade secrets or commercial property public in accordance with the individuals associated with the grant such as patentable material, and provisions set forth in sections applications, the disclosure of which personal information concerning 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., would constitute a clearly unwarranted individuals associated with the grant as amended. The grant applications and invasion of personal privacy. applications and/or contract proposals, the discussions could disclose Name of Committee: Center for Scientific the disclosure of which would confidential trade secrets or commercial Review, Special Emphasis Panel; constitute a clearly unwarranted property such as patentable material, Applications in Biobehavioral Regulation, invasion of personal privacy. Learning, and Ethology. and personal information concerning individuals associated with the grant Name of Committee: National Advisory Date: December 21, 2016. applications, the disclosure of which Council for Biomedical Imaging and Time: 11:00 a.m. to 12:00 p.m. Bioengineering. Agenda: To review and evaluate grant would constitute a clearly unwarranted applications. invasion of personal privacy. Date: January 24, 2017. Open: 8:30 a.m. to 12:00 p.m. Place: National Institutes of Health, 6701 Name of Committee: National Institute of Agenda: Report from the Institute Director, Rockledge Drive, Bethesda, MD 20892 Biomedical Imaging and Bioengineering other Institute Staff and scientific (Telephone Conference Call). Special Emphasis Panel. Contact Person: Andrea B Kelly, Ph.D., presentation. Date: February 23, 2017. Scientific Review Officer, Center for Place: The William F. Bolger Center, Time: 11:00 a.m. to 4:00 p.m. Scientific Review, National Institutes of Franklin Building, Classroom 15/16, 9600 Health, 6701 Rockledge Drive, Room 3182, Agenda: To review and evaluate grant Newbridge Drive, Potomac, MD 20854. MSC 7770, Bethesda, MD 20892, (301) 455– applications. Closed: 1:30 p.m. to 3:30 p.m. 1761, kellya2@csr.nih.gov. Place: National Institutes of Health, Two Agenda: To review and evaluate grant Democracy Plaza, Suite 920, 6707 Democracy This notice is being published less than 15 Boulevard, Bethesda, MD 20892 (Virtual applications and/or proposals. days prior to the meeting due to the timing Meeting). Place: The William F. Bolger Center, limitations imposed by the review and Contact Person: Manana Sukhareva, Ph.D., Franklin Building, Classroom 15/16, 9600 funding cycle. Scientific Review Officer, National Institute Newbridge Drive, Potomac, MD 20854. (Catalogue of Federal Domestic Assistance of Biomedical Imaging and Bioengineering, Contact Person: David T. George, Ph.D., Program Nos. 93.306, Comparative Medicine; National Institutes of Health, 6707 Acting Associate Director, Office of Research 93.333, Clinical Research, 93.306, 93.333, Democracy Boulevard, Suite 959, Bethesda, Administration, National Institute of 93.337, 93.393–93.396, 93.837–93.844, MD 20892, (301) 451–3397, sukharem@ Biomedical Imaging and Bioengineering, 93.846–93.878, 93.892, 93.893, National mail.nih.gov. 6707 Democracy Boulevard, Room 920, Institutes of Health, HHS) Bethesda, MD 20892. Dated: December 8, 2016. Dated: December 8, 2016. Any interested person may file written David Clary, comments with the committee by forwarding Michelle Trout, Program Analyst, Office of Federal Advisory the statement to the Contact Person listed on Program Analyst, Office of Federal Advisory Committee Policy. this notice. The statement should include the Committee Policy. [FR Doc. 2016–30075 Filed 12–14–16; 8:45 am] name, address, telephone number and when [FR Doc. 2016–30072 Filed 12–14–16; 8:45 am] BILLING CODE 4140–01–P applicable, the business or professional BILLING CODE 4140–01–P affiliation of the interested person. Information is also available on the DEPARTMENT OF HEALTH AND Institute’s/Center’s home page: http:// DEPARTMENT OF HEALTH AND HUMAN SERVICES www.nibib1.nih.gov/about/NACBIB/ HUMAN SERVICES NACBIB.htm, where an agenda and any National Institutes of Health additional information for the meeting will National Institutes of Health be posted when available. rmajette on DSK2TPTVN1PROD with NOTICES National Institute of Biomedical Dated: December 8, 2016. National Human Genome Research Imaging and Bioengineering; Notice of David Clary, Institute; Notice of Closed Meeting Meeting Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the Pursuant to section 10(d) of the Committee Policy. Federal Advisory Committee Act, as Federal Advisory Committee Act, as [FR Doc. 2016–30074 Filed 12–14–16; 8:45 am] amended (5 U.S.C. App.), notice is amended (5 U.S.C. App.), notice is BILLING CODE 4140–01–P hereby given of the following meeting. VerDate Sep<11>2014 15:19 Dec 14, 2016 Jkt 241001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\15DEN1.SGM 15DEN1


Document Created: 2016-12-15 01:10:23
Document Modified: 2016-12-15 01:10:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by January 17, 2017.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 90857 
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