Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 71922-71923 [2020-25019]
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Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity
Review labels to follow guidance recommendations ....................................
Redesign labels to follow guidance recommendations ....................................
Total ................................................
1 There
Number of
disclosures per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
Total capital
costs
77,500
1
77,500
1
77,500
0
775
1
775
16
12,400
$1,414,375
........................
..........................
........................
........................
89,900
1,414,375
are no operating and maintenance costs associated with this collection of information.
We base these estimates from our
experience with our food allergen
labeling program and our labeling cost
model. We estimate that there are
approximately 775,000 Universal
Product Codes (UPCs) of FDA-regulated
foods. Using FDA’s labeling cost model,
we estimate the entry rate of new UPCs
to be approximately 8 percent per year.
Based on the approximate entry rate of
new UPCs, we estimate the rate of new
or reformulated UPCs to be
approximately 10 percent per year, or
77,500 products (775,000 ×10 percent).
Thus, we estimate that 77,500 new or
reformulated products are sold annually
in the United States. Assuming an
association of 1 respondent to each of
the 77,500 new or reformulated
products, we estimate that 77,500
respondents will each review the label
of one of the 77,500 new or
reformulated products, as reported in
table 1, row 1. We have no data on how
many label reviews would identify an
opportunity to redesign the label.
Therefore, we further estimate, for the
purposes of this analysis, that 1 percent
of the reviewed labels of new or
reformulated products, or 775 labels
(77,500 × 1 percent) would be
redesigned as recommended by the
guidance. Assuming an association of 1
respondent to each of the 775 labels, we
estimate that 775 respondents will each
redesign 1 label. Using our labeling cost
model, we estimate that it will take an
average of 16 hours to complete the
administration and internal design work
for the redesign of a label to follow the
recommendations of the guidance, as
reported in table 1, row 2.
Consequently, the burden of redesigning
the 775 labels of new or reformulated
products is 12,400 hours, as reported in
table 1, row 2.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: November 2, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24727 Filed 11–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–N–3065; FDA–
2016–N–4620; FDA–2019–N–6063; FDA–
2017–N–1066; FDA–2018–N–3065; FDA–
2008–N–0424; and FDA–2019–N–5711]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
jbell on DSKJLSW7X2PROD with NOTICES
Title of collection
Required Warnings for Cigarette Packages and Advertisements ...........................................................................
Medical Devices; Reports of Corrections and Removals ........................................................................................
Customer/Partner Service Surveys .........................................................................................................................
Annual Reporting for Custom Device Exemption ....................................................................................................
Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act ......
Postmarketing Safety Reporting for Combination Products ....................................................................................
Importation of Prescription Drugs ............................................................................................................................
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0910–0877
0910–0359
0910–0360
0910–0767
0910–0800
0910–0834
0910–0888
Date approval
expires
04/30/2023
10/31/2023
10/31/2023
10/31/2023
10/31/2023
10/31/2023
10/31/2023
Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices
Dated: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25019 Filed 11–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0998]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the collections of
information in the regulations for in
vivo radiopharmaceuticals used for
diagnosis and monitoring.
DATES: Submit either electronic or
written comments on the collection of
information by January 11, 2021.
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 11,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 11, 2021.
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.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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://
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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
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–
2014–N–0998 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring.’’ 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, 240–402–7500.
• 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
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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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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,
including each proposed extension of an
existing 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
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]]>Agencies
[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71922-71923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25019]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2019-N-3065; FDA-2016-N-4620; FDA-2019-N-6063; FDA-
2017-N-1066; FDA-2018-N-3065; FDA-2008-N-0424; and FDA-2019-N-5711]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Required Warnings for Cigarette Packages 0910-0877 04/30/2023
and Advertisements.....................
Medical Devices; Reports of Corrections 0910-0359 10/31/2023
and Removals...........................
Customer/Partner Service Surveys........ 0910-0360 10/31/2023
Annual Reporting for Custom Device 0910-0767 10/31/2023
Exemption..............................
Human Drug Compounding Under Sections 0910-0800 10/31/2023
503A and 503B of the Federal Food,
Drug, and Cosmetic Act.................
Postmarketing Safety Reporting for 0910-0834 10/31/2023
Combination Products...................
Importation of Prescription Drugs....... 0910-0888 10/31/2023
------------------------------------------------------------------------
[[Page 71923]]
Dated: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25019 Filed 11-10-20; 8:45 am]
BILLING CODE 4164-01-P
