Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Generic Drug User Fee Act Cover Sheet, 27512-27513 [2017-12432]
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
107.260; Revision of an infant formula recall ......................
Total 2
1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section; activity
Total hours
1
1
1
25
25
........................
............................................................................
........................
........................
........................
........................
There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2 reports FDA’s third-party
disclosure burden estimates for
§§ 107.230 and 107.260. The estimated
burden hours per disclosure is an
average based on FDA’s experience. The
third-party disclosure burden in
§ 107.230 is the requirement to
promptly notify each affected direct
account (customer) about the recall, and
if the recalled formula presents a risk to
human health, the recalling firm must
also request that each establishment that
sells the recalled formula post a notice
of the recall at the point of purchase.
FDA estimates that two respondents
will conduct infant formula recalls
under § 107.230 and that it will take a
respondent 50 hours to comply with the
third-party disclosure requirements of
that section, for a total of 100 hours. The
third-party disclosure burden in
§ 107.260 is the requirement to issue
additional notifications where the recall
strategy or implementation is
determined to be deficient. FDA
estimates that one respondent will issue
additional notifications under § 107.260
and that it will take a respondent 25
hours to comply with the third-party
disclosure requirements of that section,
for a total of 25 hours.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12437 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Form FDA 3728, Animal Generic User
Fee Act Cover Sheet—21 U.S.C. 379j–
21—OMB Control Number 0910–0632—
Extension
[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.
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.
SUMMARY:
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.
ADDRESSES:
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
FOR FURTHER INFORMATION CONTACT:
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Average
burden per
disclosure
Total annual
disclosures
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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:
E:\FR\FM\15JNN1.SGM
15JNN1
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
27513
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Form FDA No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Application and Other
Forms Utilized by the National Health
Service Corps (NHSC) Scholarship
Program (SP), the NHSC Students To
Service Loan Repayment Program
(S2S LRP), and the Native Hawaiian
Health Scholarship Program (NHHSP),
OMB No. 0915–0146—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than July 17, 2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
pmangrum on DSK3GDR082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Application and Other Forms Utilized
by the National Health Service Corps
(NHSC) Scholarship Program (SP), the
NHSC Students to Service Loan
Repayment Program (S2S LRP), and the
Native Hawaiian Health Scholarship
Program (NHHSP), OMB No. 0915–
0146—Revision
Abstract: Administered by HRSA’s
Bureau of Health Workforce (BHW), the
NHSC SP, NHSC S2S LRP, and the
NHHSP provide scholarships or loan
repayment to qualified students who are
pursuing primary care health
professions education and training. In
return, students agree to provide
primary health care services in
medically underserved communities
located in federally designated Health
Professional Shortage Areas once they
are fully trained and licensed health
professionals. Awards are made to
applicants who demonstrate the greatest
potential for successful completion of
their education and training as well as
commitment to provide primary health
care services to communities of greatest
need. The information from program
applications, forms, and supporting
documentation is used to select the best
qualified candidates for these
competitive awards, and to monitor
program participants’ enrollment in
school, postgraduate training, and
compliance with program requirements.
The revisions to this information
collection request include the removal
of two forms for the NHSC S2S LRP
application section.
Although some program forms vary
from program to program (see programspecific burden charts below), required
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Frm 00052
Fmt 4703
Sfmt 4703
forms generally include: A program
application, academic and nonacademic letters of recommendation, the
authorization to release information,
and the acceptance/verification of good
standing report. Additional forms for
the NHSC SP include the data collection
worksheet, which is completed by the
educational institutions of program
participants; the post graduate training
verification form (also applicable for
NHSC S2S LRP participants), which is
completed by program participants and
their residency director; and the
enrollment verification form, which is
completed by program participants and
the educational institution for each
academic term.
Need and Proposed Use of the
Information: The NHSC SP, S2S LRP,
and NHHSP applications, forms, and
supporting documentation are used to
collect necessary information from
applicants that will enable BHW to
make selection determinations for the
competitive awards, and to monitor
compliance with program requirements.
Likely Respondents: Qualified
students who are pursuing education
and training in primary care health
professions education and training, and
are interested in working in health
professional shortage areas.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The revision contributes to
a reduction of burden of approximately
100 hours. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden—
Hours
E:\FR\FM\15JNN1.SGM
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Agencies
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27512-27513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12432]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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