83 FR 15152 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 68 (April 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 68 (April 9, 2018)
| Page Range | 15152-15153 | |
| FR Document | 2018-07146 |
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)] [Notices] [Pages 15152-15153] From the Federal Register Online [www.thefederalregister.org] [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
![15152 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
requests an exemption and provides supports the quality factor for the Further, we estimate that a report based
assurances, as required under § 106.121, biological quality of the protein. We on the PER study will be generated and
that changes made by the manufacturer estimate that the infant formula industry that this study report will take a senior
to an existing infant formula are limited submits a total of 35 PER submissions: scientist 1 hour to generate. Therefore,
to changing the type of packaging. A 34 exemption requests and the results of a total of 9 hours will be required to
manufacturer may also be exempt from 1 PER study. fulfill the requirements for § 106.96(f): 8
this requirement under § 106.100(g)(2), A PER study conducted according to hours for the PER study and data
if the manufacturer requests an the Association of Analytical collection, and 1 hour for the
exemption and provides assurances, as Communities Official Method 960.48 is
development of a report based on the
required under § 106.121, that 28 days in duration. We estimate that
PER study, as shown in rows 25 and 26
demonstrate to FDA’s satisfaction that there will be 10 rats in the control and
test groups (20 rats total) and that food of table 2.
the change to an existing formula does
not affect the bioavailability of the consumption and body weight will be We estimate that five firms will
protein. Finally, a manufacturer of measured at day 0 and at 7-day intervals expend approximately 20,000 hours per
infant formula may be exempt from this during the 28-day study period (a total year to fully satisfy the recordkeeping
requirement under § 106.96(g)(3) if the of 5 records per rat). We further estimate requirements in § 106.100 and that three
manufacturer requests an exemption that measuring and recording food firms will expend approximately 9,000
and provides assurances, as required consumption and body weight will take hours per year to fully satisfy the
under § 106.121(i), that demonstrate that 5 minutes per rat. Therefore, 20 rats × recordkeeping requirements in
an alternative method to the PER that is 5 records = 100 records; 100 records × § 107.50(c)(3). Thus, the total
based on sound scientific principles is 0.08 hour minutes per record = 8 hours recordkeeping burden is 40,232 hours.
available to show that the formula to fulfill the requirements of § 106.96(f).
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Total Average
Number of disclosures Total
21 CFR section annual burden per
respondents per hours
disclosures disclosure
respondent
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 DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: Ila
labeling requirements in §§ 107.10(a) HUMAN SERVICES S. Mizrachi, Office of Operations, Food
and 107.20 requires 520 hours annually and Drug Administration, Three White
by five manufacturers. Food and Drug Administration Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
Dated: April 3, 2018. [Docket Nos. FDA–2014–N–0075; FDA–
20852, 301–796–7726, PRAStaff@
Leslie Kux, 2011–N–0015; FDA–2011–N–0076; FDA–
2017–N–0932; FDA–2016–N–4487; FDA– fda.hhs.gov.
Associate Commissioner for Policy.
2014–N–0345; FDA–2013–N–0523; FDA– SUPPLEMENTARY INFORMATION: The
[FR Doc. 2018–07147 Filed 4–6–18; 8:45 am] 2017–N–2428; FDA–2008–N–0312; and following is a list of FDA information
BILLING CODE 4164–01–P FDA–2014–N–1072] collections recently approved by OMB
under section 3507 of the Paperwork
Agency Information Collection
Reduction Act of 1995 (44 U.S.C. 3507).
Activities; Announcement of Office of
The OMB control number and
Management and Budget Approvals
expiration date of OMB approval for
AGENCY: Food and Drug Administration, each information collection are shown
HHS. in table 1. Copies of the supporting
ACTION: Notice. statements for the information
collections are available on the internet
SUMMARY: The Food and Drug at https://www.reginfo.gov/public/do/
Administration (FDA) is publishing a PRAMain. An Agency may not conduct
list of information collections that have or sponsor, and a person is not required
been approved by the Office of to respond to, a collection of
Management and Budget (OMB) under information unless it displays a
the Paperwork Reduction Act of 1995. currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
sradovich on DSK3GMQ082PROD with NOTICES
OMB
Title of collection approval
Control No. expires
Good Laboratory Practice Regulations for Nonclinical Studies .............................................................................. 0910–0119 1/31/2021
Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Ad-
ministration Form for Orphan Medicinal Product Designation ............................................................................. 0910–0167 1/31/2021
Electronic Records: Electronic Signatures .............................................................................................................. 0910–0303 1/31/2021
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings ........................................... 0910–0848 1/31/2021
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![Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15153
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
Date
OMB
Title of collection approval
Control No. expires
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Pro-
motion ................................................................................................................................................................... 0910–0849 1/31/2021
Data to Support Drug Product Communications ..................................................................................................... 0910–0695 2/28/2021
Applications for FDA Approval to Market a New Drug ........................................................................................... 0910–0001 3/31/2021
Animal Drug Adverse Event Reporting and Recordkeeping ................................................................................... 0910–0284 3/31/2021
Extralabel Drug Use in Animals .............................................................................................................................. 0910–0325 3/31/2021
Application for Participation in FDA Fellowship Programs ...................................................................................... 0910–0780 3/31/2021
Dated: April 3, 2018. Food and Drug Administration, Three plan for submitting stored reports that
Leslie Kux, White Flint North, 10A–12M, 11601 were not submitted within regulatory
Associate Commissioner for Policy. Landsdown St., North Bethesda, MD timeframes. We estimate that each firm
[FR Doc. 2018–07146 Filed 4–6–18; 8:45 am] 20852, 301–796–5733, PRAStaff@ will take approximately 50 hours to
BILLING CODE 4164–01–P
fda.hhs.gov. prepare the adverse event reporting plan
SUPPLEMENTARY INFORMATION: In for its COOP.
compliance with 44 U.S.C. 3507, FDA We estimate that approximately 500
DEPARTMENT OF HEALTH AND has submitted the following proposed firms will be unable to fulfill normal
HUMAN SERVICES collection of information to OMB for adverse event reporting requirements
review and clearance. because of conditions caused by an
Food and Drug Administration
Guidance for Industry on influenza pandemic and that these firms
[Docket No. FDA–2008–D–0610] Postmarketing Adverse Event Reporting will notify the appropriate FDA
for Medical Products and Dietary organizational unit responsible for
Agency Information Collection adverse event reporting compliance
Supplements During an Influenza
Activities; Submission for Office of when the conditions exist. Although we
Pandemic
Management and Budget Review; do not anticipate such pandemic
Comment Request; Guidance for OMB Control Number 0910–0701— influenza conditions to occur every
Industry on Postmarketing Adverse Extension year, for purposes of the PRA, we
Event Reporting for Medical Products This information collection supports estimate that each of these firms will
and Dietary Supplements During an the above captioned Agency guidance. notify FDA approximately once each
Influenza Pandemic The guidance includes year and that each notification will take
AGENCY: Food and Drug Administration, recommendations for planning, approximately 8 hours to prepare and
HHS. notification, and documentation for submit.
ACTION: Notice. firms that report postmarketing adverse Concerning the recommendation in
events. The guidance recommends that the guidance that firms unable to fulfill
SUMMARY: The Food and Drug each firm’s pandemic influenza
normal adverse event reporting
Administration (FDA) is announcing continuity of operations plan (COOP)
requirements maintain documentation
that a proposed collection of include instructions for reporting
of the conditions that prevent them from
information has been submitted to the adverse events, including a plan for the
meeting these requirements and also
Office of Management and Budget submission of stored reports that were
maintain records to identify what
(OMB) for review and clearance under not submitted within regulatory
timeframes. The guidance explains that adverse event reports have been stored
the Paperwork Reduction Act of 1995. and when the reporting process is
DATES: Fax written comments on the firms that are unable to fulfill normal
adverse event reporting requirements restored, we estimate that
collection of information by May 9, approximately 500 firms will each need
2018. during an influenza pandemic should:
(1) Maintain documentation of the approximately 8 hours to maintain the
ADDRESSES: To ensure that comments on
conditions that prevent them from documentation and that approximately
the information collection are received, meeting normal reporting requirements; 500 firms will each need approximately
OMB recommends that written (2) notify the appropriate FDA 8 hours to maintain the records.
comments be faxed to the Office of organizational unit responsible for In the Federal Register of October 31,
Information and Regulatory Affairs, adverse event reporting compliance 2017 (82 FR 50431) we published a
OMB, Attn: FDA Desk Officer, Fax: 202– when the conditions exist and when the notice inviting public comment of the
395–7285, or emailed to oira_ reporting process is restored; and (3) proposed collection of information.
submission@omb.eop.gov. All maintain records to identify what Although one comment was received, it
comments should be identified with the reports have been stored. did not respond to any of the four
OMB control number 0910–0701. Also Based on the number of information collection topics solicited
include the FDA docket number found
sradovich on DSK3GMQ082PROD with NOTICES
manufacturers that would be covered by in the notice under the PRA. We
in brackets in the heading of this the guidance, we estimate that therefore made no changes to our
document. approximately 5,000 firms will add the estimate of the burden for the
FOR FURTHER INFORMATION CONTACT: following to their COOP: (1) Instructions information collection, which remains
Domini Bean, Office of Operations, for reporting adverse events and (2) a as follows:
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Document Created: 2018-04-07 02:39:05
Document Modified: 2018-04-07 02:39:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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] | |
| FR Citation | 83 FR 15152 |
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