Document ID: FDA-2016-N-2066-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of
Identity for Freedom of Information Act and Privacy Act Requests
Posted Date: 2020-04-03T04:00Z

[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18984-18985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06996]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2066]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Certification of 
Identity for Freedom of Information Act and Privacy Act Requests

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: Submit written comments (including recommendations) on the 
collection of information by May 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0832. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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.

Certification of Identity; Form FDA 3975

OMB Control Number 0910-0832--Extension

    This information collection supports Form FDA 3975 entitled 
``Certification of Identity,'' which is used by FDA to identify an 
individual requesting a particular record under the Freedom of 
Information Act (FOIA) and the Privacy Act. The form is available from 
our website at: https://www.fda.gov/

[[Page 18985]]

RegulatoryInformation/FOI/default.htm, although if an individual 
requests one, we will send it by mail or email. The form is required 
only if an individual makes an FOIA request or Privacy Act request for 
records about himself and has not provided sufficient assurances of 
identity in the incoming FOIA or Privacy Act request.
    The FOIA grants the public a right to access Federal records not 
normally prepared for public distribution. The Privacy Act grants a 
right of access to members of the public who seek access to one's own 
records that are maintained in an Agency's system of records (i.e., the 
records are retrieved by that individual's name or other personal 
identifier). The statutes overlap, and individuals who request their 
own records are processed under both statutes. The Agency may need to 
confirm that the individual making the FOIA or Privacy Act request is 
indeed the same person named in the Agency records. Respondents to the 
information collection are asked for certain information including 
name, citizenship status, social security number, address, date of 
birth, place of birth, signature, and date of signature.
    In the Federal Register of November 22, 2019 (84 FR 64539), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received stating it was 
important that FDA retain the information collection to help protect 
against potential identity fraud. The comment also suggested that the 
associated burden for completing and submitting Form FDA 3975 may be 
lower than estimated, but did not provide alternative figures for us to 
consider. We therefore retain our burden estimate, which is as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
          FDA form No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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3975; Certification of Identity.              50               1              50            0.17             8.5
                                                                                    (10 minutes)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on Agency data, we have received no more than 50 submissions 
since establishing the collection in 2017.

    Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06996 Filed 4-2-20; 8:45 am]
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