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

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 cle...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2012-N-0427]

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 May 18, 2016.

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 . 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:

FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, .

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—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 (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 “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; ( printed page 22620) Accreditation Criteria” provides information for those interested in participating in this voluntary program.

In the Federal Register of October 21, 2015 (80 FR 63806), 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
Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours
Request for accreditation 1 1 1 80 80
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 12, 2016.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2016-08893 Filed 4-15-16; 8:45 am]

BILLING CODE 4164-01-P

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81 FR 22619

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“Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program,” thefederalregister.org (April 18, 2016), https://thefederalregister.org/documents/2016-08893/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-medical-d.