82 FR 27512 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Generic Drug User Fee Act Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27512-27513
FR Document		2017-12432

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.

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27512-27513]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-12432]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Generic Drug
User Fee Act Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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 July
17, 2017.

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 0910-0632.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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.

Form FDA 3728, Animal Generic User Fee Act Cover Sheet--21 U.S.C. 379j-
21--OMB Control Number 0910-0632--Extension

Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 379j-21) establishes three different kinds of user
fees: (1) Fees for certain types of abbreviated applications for
generic new animal drugs; (2) annual fees for certain generic new
animal drug products; and (3) annual fees for certain sponsors of
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). Because concurrent submission of user fees with
applications is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3728 is the Animal Generic Drug
User Fee Act (AGDUFA) Cover Sheet, which is designed to collect the
minimum necessary information to determine whether a fee is required
for review of an application, to determine the amount of the fee
required, and to account for and track user fees. The form, when
completed electronically, will result in the generation of a unique
payment identification number used by FDA to track the payment. It will
be used by FDA's Center for Veterinary Medicine and FDA's Office of
Financial Management to initiate the administrative screening of new
generic animal drug applications to determine if payment has been
received.
In the Federal Register of September 2, 2016 (81 FR 60707), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:

[[Page 27513]]

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728....................................... 20 2 40 .08 (5 minutes)........................ 3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Respondents to this collection of information are new generic
animal drug applicants. Based on Agency data for the past 3 years, FDA
estimates there are approximately 40 submissions annually and a total
of 3.2 burden hours. The burden for this information collection has not
changed since the last OMB approval.

Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12432 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P

27512 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of disclosures Total annual
21 CFR section; activity burden per Total hours
respondents per disclosures disclosure
respondent

107.260; Revision of an infant formula recall ...................... 1 1 1 25 25

Total 2 ............................................................................ ........................ ........................ ........................ ........................ ........................
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2 reports FDA’s third-party DEPARTMENT OF HEALTH AND collection of information to OMB for
disclosure burden estimates for HUMAN SERVICES review and clearance.
§§ 107.230 and 107.260. The estimated Form FDA 3728, Animal Generic User
burden hours per disclosure is an Food and Drug Administration
Fee Act Cover Sheet—21 U.S.C. 379j–
average based on FDA’s experience. The [Docket No. FDA–2011–N–0655] 21—OMB Control Number 0910–0632—
third-party disclosure burden in Extension
§ 107.230 is the requirement to Agency Information Collection
promptly notify each affected direct Activities; Submission for Office of Section 741 of the Federal Food, Drug,
account (customer) about the recall, and Management and Budget Review; and Cosmetic Act (the FD&C Act) (21
if the recalled formula presents a risk to Comment Request; Animal Generic U.S.C. 379j–21) establishes three
Drug User Fee Act Cover Sheet different kinds of user fees: (1) Fees for
human health, the recalling firm must
certain types of abbreviated applications
also request that each establishment that AGENCY: Food and Drug Administration, for generic new animal drugs; (2) annual
sells the recalled formula post a notice HHS. fees for certain generic new animal drug
of the recall at the point of purchase. products; and (3) annual fees for certain
ACTION: Notice.
FDA estimates that two respondents sponsors of abbreviated applications for
will conduct infant formula recalls SUMMARY: The Food and Drug generic new animal drugs and/or
under § 107.230 and that it will take a Administration (FDA) is announcing investigational submissions for generic
respondent 50 hours to comply with the that a proposed collection of new animal drugs (21 U.S.C. 379j–
third-party disclosure requirements of information has been submitted to the 21(a)). Because concurrent submission
that section, for a total of 100 hours. The Office of Management and Budget of user fees with applications is
third-party disclosure burden in (OMB) for review and clearance under required, the review of an application
§ 107.260 is the requirement to issue the Paperwork Reduction Act of 1995. cannot begin until the fee is submitted.
additional notifications where the recall DATES: Fax written comments on the Form FDA 3728 is the Animal Generic
strategy or implementation is collection of information by July 17, Drug User Fee Act (AGDUFA) Cover
determined to be deficient. FDA 2017. Sheet, which is designed to collect the
estimates that one respondent will issue minimum necessary information to
ADDRESSES: To ensure that comments on
additional notifications under § 107.260 determine whether a fee is required for
the information collection are received,
and that it will take a respondent 25 review of an application, to determine
OMB recommends that written
hours to comply with the third-party the amount of the fee required, and to
comments be faxed to the Office of
disclosure requirements of that section, account for and track user fees. The
Information and Regulatory Affairs,
for a total of 25 hours. form, when completed electronically,
OMB, Attn: FDA Desk Officer, FAX:
will result in the generation of a unique
Dated: June 12, 2017. 202–395–7285, or emailed to oira_
payment identification number used by
Anna K. Abram, submission@omb.eop.gov. All
FDA to track the payment. It will be
comments should be identified with the
Deputy Commissioner for Policy, Planning, used by FDA’s Center for Veterinary
OMB control number 0910–0632. Also
Legislation, and Analysis. Medicine and FDA’s Office of Financial
include the FDA docket number found
[FR Doc. 2017–12437 Filed 6–14–17; 8:45 am] Management to initiate the
in brackets in the heading of this
administrative screening of new generic
BILLING CODE 4164–01–P document.
animal drug applications to determine if
FOR FURTHER INFORMATION CONTACT: Ila payment has been received.
S. Mizrachi, Office of Operations, Food In the Federal Register of September
and Drug Administration, Three White 2, 2016 (81 FR 60707), FDA published
Flint North, 10A63, 11601 Landsdown a 60-day notice requesting public
St., North Bethesda, MD 20852, 301– comment on the proposed collection of
796–7726, PRAStaff@fda.hhs.gov. information. No comments were
SUPPLEMENTARY INFORMATION: In received.
compliance with 44 U.S.C. 3507, FDA FDA estimates the burden of this
has submitted the following proposed collection of information as follows:
pmangrum on DSK3GDR082PROD with NOTICES

VerDate Sep<11>2014 14:10 Jun 14, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1

Document Created: 2017-06-15 01:03:38
Document Modified: 2017-06-15 01:03:38

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.
Dates		Fax written comments on the collection of information by July 17, 2017.
Contact		Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation		82 FR 27512

82 FR 27512 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Generic Drug User Fee Act Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration