Document ID: FDA-2012-N-0427-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program
Posted Date: 2019-07-18T04:00Z

[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34401-34402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15269]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0427]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Inspection by Accredited Persons Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 August 
19, 2019.

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 0910-0510. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St. North Bethesda, MD 20852, 301-796-8867, 
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.

Inspection by Accredited Persons Program Under the Medical Device User 
Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; 
Accreditation Criteria

OMB Control Number 0910-0510--Extension

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Pub. L. 107-250) was signed into law on October 26, 2002. Section 201 
of MDUFMA added a new paragraph (g) to section 704 of the Federal, 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 374), directing FDA 
to accredit third parties (accredited persons) to conduct inspections 
of eligible manufacturers of class II or class III devices. FDA's 
guidance document entitled ``Inspection by Accredited Persons Under The 
Medical Device User Fee and Modernization Act of 2002 and the FDA 
Amendments Act of 2007; Accreditation Criteria'' \1\ provides 
information for those interested in participating in this voluntary 
program.
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    \1\ https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm089721.pdf.
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    In the Federal Register of March 14, 2019 (84 FR 9352), 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 collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                 Section of the FD&C Act; Activity                      Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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704(g); Request for Accreditation..................................               1                1                1               80               80
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 34402]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15269 Filed 7-17-19; 8:45 am]
 BILLING CODE 4164-01-P