Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 15152-15153 [2018-07146]
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15152
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
requests an exemption and provides
assurances, as required under § 106.121,
that changes made by the manufacturer
to an existing infant formula are limited
to changing the type of packaging. A
manufacturer may also be exempt from
this requirement under § 106.100(g)(2),
if the manufacturer requests an
exemption and provides assurances, as
required under § 106.121, that
demonstrate to FDA’s satisfaction that
the change to an existing formula does
not affect the bioavailability of the
protein. Finally, a manufacturer of
infant formula may be exempt from this
requirement under § 106.96(g)(3) if the
manufacturer requests an exemption
and provides assurances, as required
under § 106.121(i), that demonstrate that
an alternative method to the PER that is
based on sound scientific principles is
available to show that the formula
supports the quality factor for the
biological quality of the protein. We
estimate that the infant formula industry
submits a total of 35 PER submissions:
34 exemption requests and the results of
1 PER study.
A PER study conducted according to
the Association of Analytical
Communities Official Method 960.48 is
28 days in duration. We estimate that
there will be 10 rats in the control and
test groups (20 rats total) and that food
consumption and body weight will be
measured at day 0 and at 7-day intervals
during the 28-day study period (a total
of 5 records per rat). We further estimate
that measuring and recording food
consumption and body weight will take
5 minutes per rat. Therefore, 20 rats ×
5 records = 100 records; 100 records ×
0.08 hour minutes per record = 8 hours
to fulfill the requirements of § 106.96(f).
Further, we estimate that a report based
on the PER study will be generated and
that this study report will take a senior
scientist 1 hour to generate. Therefore,
a total of 9 hours will be required to
fulfill the requirements for § 106.96(f): 8
hours for the PER study and data
collection, and 1 hour for the
development of a report based on the
PER study, as shown in rows 25 and 26
of table 2.
We estimate that five firms will
expend approximately 20,000 hours per
year to fully satisfy the recordkeeping
requirements in § 106.100 and that three
firms will expend approximately 9,000
hours per year to fully satisfy the
recordkeeping requirements in
§ 107.50(c)(3). Thus, the total
recordkeeping burden is 40,232 hours.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
Nutrient labeling; 21 CFR 107.10(a) and 107.20 ................
5
13
65
8
520
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate compliance with our
labeling requirements in §§ 107.10(a)
and 107.20 requires 520 hours annually
by five manufacturers.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[Docket Nos. FDA–2014–N–0075; FDA–
2011–N–0015; FDA–2011–N–0076; FDA–
2017–N–0932; FDA–2016–N–4487; FDA–
2014–N–0345; FDA–2013–N–0523; FDA–
2017–N–2428; FDA–2008–N–0312; and
FDA–2014–N–1072]
[FR Doc. 2018–07147 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
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:
sradovich on DSK3GMQ082PROD with NOTICES
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
Control No.
Title of collection
Good Laboratory Practice Regulations for Nonclinical Studies ..............................................................................
Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation .............................................................................
Electronic Records: Electronic Signatures ..............................................................................................................
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings ...........................................
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Date
approval
expires
0910–0119
1/31/2021
0910–0167
0910–0303
0910–0848
1/31/2021
1/31/2021
1/31/2021
15153
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB
Control No.
Title of collection
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion ...................................................................................................................................................................
Data to Support Drug Product Communications .....................................................................................................
Applications for FDA Approval to Market a New Drug ...........................................................................................
Animal Drug Adverse Event Reporting and Recordkeeping ...................................................................................
Extralabel Drug Use in Animals ..............................................................................................................................
Application for Participation in FDA Fellowship Programs ......................................................................................
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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.
[FR Doc. 2018–07146 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0610]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Medical Products
and Dietary Supplements During an
Influenza Pandemic
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Fax written comments on the
collection of information by May 9,
2018.
ADDRESSES: 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 0910–0701. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Guidance for Industry on
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic
OMB Control Number 0910–0701—
Extension
This information collection supports
the above captioned Agency guidance.
The guidance includes
recommendations for planning,
notification, and documentation for
firms that report postmarketing adverse
events. The guidance recommends that
each firm’s pandemic influenza
continuity of operations plan (COOP)
include instructions for reporting
adverse events, including a plan for the
submission of stored reports that were
not submitted within regulatory
timeframes. The guidance explains that
firms that are unable to fulfill normal
adverse event reporting requirements
during an influenza pandemic should:
(1) Maintain documentation of the
conditions that prevent them from
meeting normal reporting requirements;
(2) notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when the conditions exist and when the
reporting process is restored; and (3)
maintain records to identify what
reports have been stored.
Based on the number of
manufacturers that would be covered by
the guidance, we estimate that
approximately 5,000 firms will add the
following to their COOP: (1) Instructions
for reporting adverse events and (2) a
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0910–0849
0910–0695
0910–0001
0910–0284
0910–0325
0910–0780
Date
approval
expires
1/31/2021
2/28/2021
3/31/2021
3/31/2021
3/31/2021
3/31/2021
plan for submitting stored reports that
were not submitted within regulatory
timeframes. We estimate that each firm
will take approximately 50 hours to
prepare the adverse event reporting plan
for its COOP.
We estimate that approximately 500
firms will be unable to fulfill normal
adverse event reporting requirements
because of conditions caused by an
influenza pandemic and that these firms
will notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when the conditions exist. Although we
do not anticipate such pandemic
influenza conditions to occur every
year, for purposes of the PRA, we
estimate that each of these firms will
notify FDA approximately once each
year and that each notification will take
approximately 8 hours to prepare and
submit.
Concerning the recommendation in
the guidance that firms unable to fulfill
normal adverse event reporting
requirements maintain documentation
of the conditions that prevent them from
meeting these requirements and also
maintain records to identify what
adverse event reports have been stored
and when the reporting process is
restored, we estimate that
approximately 500 firms will each need
approximately 8 hours to maintain the
documentation and that approximately
500 firms will each need approximately
8 hours to maintain the records.
In the Federal Register of October 31,
2017 (82 FR 50431) we published a
notice inviting public comment of the
proposed collection of information.
Although one comment was received, it
did not respond to any of the four
information collection topics solicited
in the notice under the PRA. We
therefore made no changes to our
estimate of the burden for the
information collection, which remains
as follows:
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]]>Agencies
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15152-15153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07146]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-N-0075; FDA-2011-N-0015; FDA-2011-N-0076; FDA-
2017-N-0932; FDA-2016-N-4487; FDA-2014-N-0345; FDA-2013-N-0523; FDA-
2017-N-2428; FDA-2008-N-0312; and FDA-2014-N-1072]
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
------------------------------------------------------------------------
Good Laboratory Practice Regulations for 0910-0119 1/31/2021
Nonclinical Studies....................
Orphan Drug Designation Request Form and 0910-0167 1/31/2021
The Common European Medicines Agency/
Food and Drug Administration Form for
Orphan Medicinal Product Designation...
Electronic Records: Electronic 0910-0303 1/31/2021
Signatures.............................
Experimental Study on Warning Statements 0910-0848 1/31/2021
for Cigarette Graphic Health Warnings..
[[Page 15153]]
Consumer and Healthcare Professional 0910-0849 1/31/2021
Identification of and Responses to
Deceptive Prescription Drug Promotion..
Data to Support Drug Product 0910-0695 2/28/2021
Communications.........................
Applications for FDA Approval to Market 0910-0001 3/31/2021
a New Drug.............................
Animal Drug Adverse Event Reporting and 0910-0284 3/31/2021
Recordkeeping..........................
Extralabel Drug Use in Animals.......... 0910-0325 3/31/2021
Application for Participation in FDA 0910-0780 3/31/2021
Fellowship Programs....................
------------------------------------------------------------------------
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07146 Filed 4-6-18; 8:45 am]
BILLING CODE 4164-01-P
