[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51455-51456]
[FR Doc No: 2016-18463]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Certification of Identity for Freedom of
Information Act and Privacy Act Requests.''

DATES: Submit either electronic or written comments on the collection
of information by October 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-2066 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Certification of Identity for
Freedom of Information Act and Privacy Act Requests.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover

sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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 20851<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Certification of Identity for Freedom of Information Act and Privacy
Act Requests OMB Control Number 0910--NEW

    In compliance with 44 U.S.C. 3507, FDA will submit to the Office of
Management and Budget a request to review and approve a new collection
of information: Certification of Identity for Freedom of Information
Act and Privacy Act Requests. This new form provides the FDA with data
necessary to identify an individual requesting a particular record
under the Freedom of Information Act (FOIA) and the Privacy Act. The
form is available at the following FDA FOIA page at: http://www.fda.gov/RegulatoryInformation/FOI/default.htm, although if an
individual requests one, we will send it by mail or email. 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.
    Members of the public who wish to access particular records will be
asked for certain information: Name, citizenship status, social
security number, address, date of birth, place of birth, signature, and
date of signature.
    FDA estimates the burden of this collection of information as
follows:
    As stated in table 1, the estimates are based on the following: The
number of FOIA and Privacy Act requests received by FDA each year that
require a certification of identity in order for FDA to process the
request. Of the 10,000 requests received per year, only a small number
require a certification of identity. In some cases, the requesters
provide their own certification of identity. Therefore, we have
estimated the number of affected individuals at 60 per year.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                FDA Form No.                    Number of      responses per     Total annual        Average  burden per  response         Total hours
                                               respondents       respondent       responses
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3975.......................................              60                1               60   .17 (10 minutes).......................              10
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18463 Filed 8-3-16; 8:45 am]
 BILLING CODE 4164-01-P