[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51455-51456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 51456]]

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 protected].

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