Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests, 64539-64541 [2019-25364]
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64539
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
program. The evaluation collects the
following information: (1) Demographic
Data; (2) Expectations of Fellowship or
Training Program; (3) Administration
Processes and Support to Fellow or
Trainee; (4) FDA Retention and Plans of
Fellow or Trainee; (5) Training and
Education Completed; and (6)
Professional/Research Goals. The
purpose of this evaluation is to assess
the effectiveness of the program and
feedback from participants to improve
the quality of the experience.
(4) To end the program, a nonemployee must submit the Exit Check
List—Participants in FDA fellowship
and traineeship programs may be asked
to complete the exit check list to
manage the exit process and return of
FDA property. The Exit Checklist guides
the exit process for the following
operations components: (1) Access Key/
Pass; (2) Accountable Property; (3)
System Applications inactive; (4)
Library Materials; (5) Government
Issued Documents (i.e., passports); (6)
Personal Identity Verification Card/
Badge; (7) Borrowed Records; (8)
Employee Records; and (9) Information
Technology Accounts.
All exit information will be entered to
terminate access to any FDA
information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average burden
per response
1,220
600
1,220
600
1
1
1
1
1
1
1
1
0.25
0.25
0.25
0.25
......
......
......
......
305
150
305
150
620
1,220
1,220
1,220
1,220
1,220
1,220
610
610
1,220
1,220
1,220
1,220
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0.25 (15 minutes) ......
0.25 (15 minutes) ......
0.25 (15 minutes) ......
1 ................................
1 ................................
1 ................................
1 ................................
0.5 (30 minutes) ........
0.5 (30 minutes) ........
0.25 (15 minutes) ......
0.25 (15 minutes) ......
0.5 (30 minutes) ........
1 ................................
155
305
305
1,220
1,220
1,220
1,220
305
305
305
305
610
1,220
Total ..................................................................
........................
........................
........................
....................................
9,605
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
information collection associated with
certain Freedom of Information Act and
Privacy Act requests.
Food and Drug Administration
DATES:
[FR Doc. 2019–25332 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
Submit either electronic or
written comments on the collection of
information by January 21, 2020.
[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
Food and Drug Administration,
HHS.
ACTION:
minutes)
minutes)
minutes)
minutes)
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
AGENCY:
(15
(15
(15
(15
Total hours
New Non-Employee Data Form ...............................
Proof of Health Insurance ........................................
Emergency Contact Information ..............................
UFMS Supplier and Site Information for Stipend
Payments, Financial Information.
CONCUR GOV New Traveler Profile ......................
Absence Recording Form ........................................
Personal Custody Property Record .........................
FDA Health Summary ..............................................
Discovery and Invention Form .................................
Training Development Plan .....................................
Final Project Report .................................................
Training Request ......................................................
Travel Request .........................................................
LMS Access .............................................................
SOP Verification .......................................................
Program Evaluation .................................................
Exit Checklist ...........................................................
1 There
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Notice.
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
SUMMARY:
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 21,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 21, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
ADDRESSES:
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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
E:\FR\FM\22NON1.SGM
22NON1
64540
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
khammond on DSKJM1Z7X2PROD with NOTICES
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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 https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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: Under the
PRA (44 U.S.C. 3501–3521), 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; 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/
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.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
3975; Certification of Identity .......................................
50
1
50
.17 (10 minutes) .....
8.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
16:57 Nov 21, 2019
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
Based on Agency data, we have
received no more than 50 submissions
since establishing the collection in
2017.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25364 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4844]
‘‘Ruby Chocolate’’ Deviating From
Identity Standard; Temporary Permit
for Market Testing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a temporary permit has
been issued to Barry Callebaut U.S.A.
LLC (the applicant) to market test a
product identified as ‘‘ruby chocolate’’
that deviates from the U.S. standards of
identity for chocolate products. The
temporary permit will allow the
applicant to evaluate commercial
viability of the product and to collect
data on consumer acceptance of the
product.
SUMMARY:
This permit is effective for 15
months, beginning on the date the
applicant introduces or causes
introduction of the test product into
interstate commerce, but not later than
February 20, 2020.
FOR FURTHER INFORMATION CONTACT:
Marjan Morravej, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2371.
SUPPLEMENTARY INFORMATION: We are
giving notice that we have issued a
temporary permit to Barry Callebaut
U.S.A. LLC. We are issuing the
temporary permit in accordance with 21
CFR 130.17, which addresses temporary
permits for interstate shipment of
experimental packs of food varying from
the requirements of definitions and
standards of identity issued under
section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341).
The permit covers the interstate
market testing of the product identified
as ‘‘ruby chocolate.’’ The test product
deviates from the U.S. standards of
identity for chocolates (21 CFR 163.111,
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
163.123, 163.124, 163.130, 163.135,
163.140, and 163.145).
For the purpose of this permit, ‘‘ruby
chocolate’’ is the solid or semiplastic
food prepared by mixing and grinding
cacao fat with one or more of the cacao
ingredients (namely, chocolate liquor,
breakfast cocoa, cocoa, and lowfat
cocoa), citric acid, one or more of
optional dairy ingredients, and one or
more optional nutritive carbohydrate
sweeteners. ‘‘Ruby chocolate’’ contains
not less than 1.5 percent nonfat cacao
solids, not less than 20 percent by
weight of cacao fat, not less than 2.5
percent by weight of milk fat, not less
than 12 percent by weight of total milk
solids, not more than 1.5 percent of
emulsifying agents, and not more than
5 percent of whey or whey products. It
may also contain other ingredients such
as antioxidants approved for food use,
spices, natural and artificial flavorings,
and other seasonings. However, these
other ingredients cannot imitate the
flavor of chocolate, milk or butter, berry
or another fruit. Additionally, ‘‘ruby
chocolate’’ contains no added coloring.
The test product ‘‘ruby chocolate’’
contains the principal ingredients used
in most of the current standards for
cacao products under 21 CFR part 163;
however, it deviates from the current
standards of identity for chocolate
products in terms of its final
composition, taste, and color.
The purpose of the temporary permit
is to allow the applicant to market test
the product throughout the United
States. The permit will allow the
applicant to evaluate commercial
viability of the product and to collect
data on consumer acceptance of the
product.
The permit provides for the temporary
marketing of approximately 60 million
pounds (27,215,540 kilograms) of the
test product. The test product will be
manufactured at the Barry Callebaut
facilities located at Aalstersestraat 122,
9280 Lebbeke, Belgium; 400 Industrial
Park Rd., St. Albans, VT 05478; and
1175 Commerce Blvd., American
Canyon, CA 94503.
Barry Callebaut U.S.A. LLC will
distribute the test product to various
manufacturers throughout the United
States for further manufacturing and
market testing. Each ingredient used in
the food must be declared on the label
as required by 21 CFR part 101. The
permit is effective for 15 months,
beginning on the date the applicant
introduces or causes the introduction of
the test product into interstate
commerce, but not later than February
20, 2020.
PO 00000
Frm 00089
Fmt 4703
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64541
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25325 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0319]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Dear Health Care
Provider Letters: Improving
Communication of Important Safety
Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) 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.
SUMMARY:
Fax written comments on the
collection of information by December
23, 2019.
DATES:
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 0910–0754. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22NON1.SGM
22NON1
Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64539-64541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25364]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 information collection associated with
certain Freedom of Information Act and Privacy Act requests.
DATES: Submit either electronic or written comments on the collection
of information by January 21, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 21, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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
[[Page 64540]]
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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; 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/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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3975; Certification of Identity............ 50 1 50 .17 (10 minutes)....................... 8.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 64541]]
Based on Agency data, we have received no more than 50 submissions
since establishing the collection in 2017.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25364 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P