Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, 72810-72811 [2016-25482]
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Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
specify the advisory committee for
which the nominee recommended.
Nominations must also acknowledge
that the nominee is aware of the
nomination unless self-nominated. FDA
will ask potential candidates to provide
detailed information concerning such
matters related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: October 18, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–25497 Filed 10–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0600]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fee Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 information collection requirements
of the Animal Drug User Fee cover
sheet.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by December 20, 2016.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
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,
VerDate Sep<11>2014
19:06 Oct 20, 2016
Jkt 241001
including attachments, to https://
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2010–N–0600 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Animal
Drug User Fee Cover Sheet.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• 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
its consideration of comments. The
second copy, which will have the
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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
the proposed collection of information
is necessary for the proper performance
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Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Animal Drug User Fee Cover Sheet—
OMB Control Number 0910–0539—
Extension
Under section 740 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 379j–12), FDA has
the authority to assess and collect
application fees from each person who
submits certain new animal drug
applications or certain supplemental
animal drug applications. The Animal
Drug User Fee cover sheet (Form FDA
3546) is designed to collect the
minimum necessary information to
determine whether a fee is required for
the review of an application or
supplement or whether an application
fee waiver was granted, to determine the
amount of the fee required, and to
assure that each animal drug user fee
payment is appropriately linked to the
animal drug application for which
payment is made. The form, when
completed electronically, will result in
the generation of a unique payment
identification number used by FDA to
track the payment. FDA’s Center for
Veterinary Medicine and FDA’s Office
of Management will use the information
collected to initiate the administrative
screening of new animal drug
applications and supplements to
determine whether the payment has
been received.
Description of Respondents:
Respondents to this collection of
information are new animal drug
applicants.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form No.
Number of
respondents
Number of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total hours
FDA 3546 ...........................
21
1
21
1
21
FD&C Act section;
description
740(a)(1); Animal Drug
User Fee cover sheet.
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates in table 1 are based on
our experience with new animal drug
applications and supplemental animal
drug applications and the average
number of Animal Drug User Fee cover
sheets submitted during fiscal years
2013–2015. We estimate 21 respondents
will each submit a cover sheet (Form
FDA 3546), for a total of 21 responses.
We calculate a reporting burden of 1
hour per response, for a total of 21
hours.
Dated: October 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25482 Filed 10–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Notice of Interest Rate on Overdue
Debts
Section 30.18 of the Department of
Health and Human Services’ claims
collection regulations (45 CFR part 30)
provides that the Secretary shall charge
an annual rate of interest, which is
determined and fixed by the Secretary
of the Treasury after considering private
consumer rates of interest on the date
that the Department of Health and
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19:06 Oct 20, 2016
Jkt 241001
Human Services becomes entitled to
recovery. The rate cannot be lower than
the Department of Treasury’s current
value of funds rate or the applicable rate
determined from the ‘‘Schedule of
Certified Interest Rates with Range of
Maturities’’ unless the Secretary waives
interest in whole or part, or a different
rate is prescribed by statute, contract, or
repayment agreement. The Secretary of
the Treasury may revise this rate
quarterly. The Department of Health and
Human Services publishes this rate in
the Federal Register.
The current rate of 95⁄8%, as fixed by
the Secretary of the Treasury, is certified
for the quarter ended September 30,
2016. This rate is based on the Interest
Rates for Specific Legislation, ‘‘National
Health Services Corps Scholarship
Program (42 U.S.C. 254o(b)(1)(A))’’ and
‘‘National Research Service Award
Program (42 U.S.C. 288(c)(4)(B)).’’ This
interest rate will be applied to overdue
debt until the Department of Health and
Human Services publishes a revision.
Dated: October 13, 2016.
David C. Horn,
Director, Office of Financial Policy and
Reporting.
[FR Doc. 2016–25459 Filed 10–20–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting Announcement for the
Technical Advisory Panel on Medicare
Trustee Reports
Department of Health and
Human Services (HHS).
ACTION: Notice of public meeting.
AGENCY:
This notice announces the
meeting dates for the Technical
Advisory Panel on Medicare Trustee
Reports on Monday, October 31, 2016
and Tuesday, November 1, 2016 in
Washington, DC.
DATES: The meeting will be held on
Monday, October 31, 2016 from 9:30
a.m. to 5:00 p.m. and Tuesday,
November 1, 2016, from 9:00 a.m. to
3:30 p.m. Eastern Daylight Time (EDT)
and it is open to the public.
ADDRESSES: The meeting will be held at
the Hubert Humphrey Building, 200
Independence Ave. SW., Washington,
DC, 20201 Room 738G.3.
FOR FURTHER INFORMATION CONTACT: Dr.
Donald Oellerich, Designated Federal
Officer, at the Office of Human Services
Policy, Assistant Secretary for Planning
and Evaluation, U.S. Department of
Health and Human Services, 200
Independence Ave. SW., Washington,
DC 20201, (202) 690–8410.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Agencies
[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72810-72811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25482]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0600]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Drug User Fee Cover Sheet
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 information collection
requirements of the Animal Drug User Fee cover sheet.
DATES: Submit either electronic or written comments on the collection
of information by December 20, 2016.
ADDRESSES: You may submit comments as follows:
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://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2010-N-0600 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Animal Drug User Fee Cover
Sheet.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
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
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 the proposed collection
of information is necessary for the proper performance
[[Page 72811]]
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Animal Drug User Fee Cover Sheet--OMB Control Number 0910-0539--
Extension
Under section 740 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 379j-12), FDA has the authority to assess and
collect application fees from each person who submits certain new
animal drug applications or certain supplemental animal drug
applications. The Animal Drug User Fee cover sheet (Form FDA 3546) is
designed to collect the minimum necessary information to determine
whether a fee is required for the review of an application or
supplement or whether an application fee waiver was granted, to
determine the amount of the fee required, and to assure that each
animal drug user fee payment is appropriately linked to the animal drug
application for which payment is made. The form, when completed
electronically, will result in the generation of a unique payment
identification number used by FDA to track the payment. FDA's Center
for Veterinary Medicine and FDA's Office of Management will use the
information collected to initiate the administrative screening of new
animal drug applications and supplements to determine whether the
payment has been received.
Description of Respondents: Respondents to this collection of
information are new animal drug applicants.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FD&C Act section; description FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1); Animal Drug User Fee cover FDA 3546.................. 21 1 21 1 21
sheet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates in table 1 are based on our experience with new
animal drug applications and supplemental animal drug applications and
the average number of Animal Drug User Fee cover sheets submitted
during fiscal years 2013-2015. We estimate 21 respondents will each
submit a cover sheet (Form FDA 3546), for a total of 21 responses. We
calculate a reporting burden of 1 hour per response, for a total of 21
hours.
Dated: October 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25482 Filed 10-20-16; 8:45 am]
BILLING CODE 4164-01-P