Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Act Waivers and Reductions, 10532-10534 [2014-04013]
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10532
Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
111.14, records of personnel practices, including documentation of training .......................................................
111.23, records of physical plant sanitation practices, including pest control and water quality ...........................
111.35, records of equipment and utensils calibration and
sanitation practices .........................................................
111.95, records of production and process control systems ................................................................................
111.140, records that quality control personnel must
make and keep ...............................................................
111.180, records associated with components, packaging, labels, and product received for packaging and
labeling as a dietary supplement ...................................
111.210, requirements for what the master manufacturing
record must include ........................................................
111.260, requirements for what the batch record must include ...............................................................................
111.325, records that quality control personnel must
make and keep for laboratory operations ......................
111.375, records of the written procedures established
for manufacturing operations .........................................
111.430, records of the written procedures for packaging
and labeling operations ..................................................
111.475, records of product distribution and procedures
for holding and distributing operations ...........................
111.535, records for returned dietary supplements ..........
111.570, records regarding product complaints ................
Total ............................................................................
emcdonald on DSK67QTVN1PROD with NOTICES
1 There
Number of
records per
recordkeeper
Average burden
per
recordkeeping
Total annual
records
Total hours
15,000
4
60,000
1
60,000
15,000
1
15,000
0.2
3,000
400
1
400
12.5
5,000
250
1
250
45
11,250
240
1163
279,120
1
279,120
240
1163
279,120
1
279,120
240
1
240
145
1408
204,160
1
204,160
120
1
120
15
1,800
260
1
260
2
520
50
1
50
12.6
630
15,000
110
240
1
4
600
15,000
440
144,000
0.4
13.5
0.5
6,000
5,940
72,000
........................
........................
........................
..........................
929,140
2.5
600
are no capital costs or operating and maintenance costs associated with this collection of information.
The average burden per recordkeeping
estimates in table 1 are based on those
in the June 25, 2007, final rule, which
were based on our institutional
experience with other CGMP
requirements and on data provided by
Research Triangle Institute in the
‘‘Survey of Manufacturing Practices in
the Dietary Supplement Industry’’ cited
in that rule.
The estimates in table 1 of the number
of firms affected by each provision of
part 111 are based on the percentage of
manufacturers, packagers, labelers,
holders, distributors, and warehousers
that reported in the survey that they
have not established written standard
operating procedures or do not maintain
records that were later required by the
June 25, 2007, final rule. Because we do
not have survey results for general
warehouses, we entered the
approximate number of facilities in that
category for those provisions covering
general facilities. For the dietary
supplement industry, the survey
estimated that 1,460 firms would be
covered by the final rule, including
manufacturers, packagers, labelers,
holders, distributors, and warehousers.
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17:58 Feb 24, 2014
Jkt 232001
The time estimates include the burden
involved in documenting that certain
requirements are performed and in
recordkeeping. We used an estimated
annual batch production of 1,408
batches per year to estimate the burden
of requirements that are related to the
number of batches produced annually,
such as § 111.260, ‘‘What must the batch
production record include?’’ The
estimate of 1,408 batches per year is
near the midpoint of the number of
annual batches reported by survey
firms.
The length of time that CGMP records
must be maintained is set forth in
§ 111.605. Table 1 reflects the estimated
burdens for written procedures, record
maintenance, periodically reviewing
records to determine if they may be
discarded, and for any associated
documentation for that activity for
records that are required under part 111.
We have not included a separate
estimate of burden for those sections
that require maintaining records in
accordance with § 111.605, but have
included those burdens under specific
provisions for keeping records. For
example, § 111.255(a) requires that the
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Frm 00067
Fmt 4703
Sfmt 4703
batch production records be prepared
every time a batch is manufactured, and
§ 111.255(d) requires that batch
production records be kept in
accordance with § 111.605. The
estimated burdens for both § 111.255(a)
and (d) are included under § 111.260
(what the batch record must include).
Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–04014 Filed 2–24–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0037]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fee Act Waivers and Reductions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\25FEN1.SGM
Notice.
25FEN1
Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices
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 paperwork burden of requesting a
waiver or reduction of fees under
Animal Drug User Fee Act (ADUFA).
DATES: Submit either electronic or
written comments on the collection of
information by April 28, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
SUMMARY:
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
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.
10533
Animal Drug User Fees and Fee
Waivers and Reductions (OMB Control
Number 0910–0540)—Extension
Enacted on November 18, 2003, the
Animal Drug User Fee Act (Pub. L. 108–
130) amended the Federal Food, Drug,
and Cosmetic Act and requires FDA to
assess and collect user fees for certain
applications, products, establishments,
and sponsors. It also requires the
Agency to grant a waiver from, or a
reduction of those fees in certain
circumstances. Thus, to implement this
statutory provision of ADUFA, FDA
developed a guidance entitled,
‘‘Guidance for Industry: Animal Drug
User Fees and Fee Waivers and
Reductions.’’ This document provides
guidance on the types of fees FDA is
authorized to collect under ADUFA, and
how to request waivers and reductions
from FDA’s animal drug user fees.
Further, this guidance also describes the
types of fees and fee waivers and
reductions; what information FDA
recommends be submitted in support of
a request for a fee waiver or reduction;
how to submit such a request; and
FDA’s process for reviewing requests.
Respondents to this collection of
information are new animal drug
sponsors. Requests or waivers or
reductions may be submitted by a
person paying any of the animal drug
user fees assessed including application
fees, product fees, establishment fees, or
sponsor fees.
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of responses
per
respondent
Number of
respondents
21 CFR section; activity
45
740(d)(1)(D); minor use or minor species ...
76
740(d)(1)(E); small business .......................
3
Request for reconsideration of a decision ...
2
Request for review (user fee appeal officer)
0
Total ......................................................
emcdonald on DSK67QTVN1PROD with NOTICES
740(d)(1)(A); significant barrier to innovation.
740(d)(1)(B); fees exceed cost ....................
740(d)(1)(C); free choice feeds ...................
........................
1 There
8
5
Total annual
responses
Average burden per
response
Total hours
1 time for each application.
3.75 .............................
1 time for each application.
1 time for each application.
1 time for each application.
1 time for each application.
1 time for each application.
45
2 ................................
90
30
5
0.5 (30 minutes) .......
2 ................................
15
10
76
2 ................................
152
3
2 ................................
6
2
2 ................................
4
0
0 ................................
0
.....................................
........................
...................................
277
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system, from
fiscal year (FY) 2010 to 2012 there were
an estimated 173 sponsors subject to
ADUFA. However, not all sponsors will
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17:58 Feb 24, 2014
Jkt 232001
have any submissions in a given year
and some may have multiple
submissions. The total number of
waiver requests is based on the average
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
number of submission types received by
FDA in FY 2010–2012.
E:\FR\FM\25FEN1.SGM
25FEN1
10534
Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices
Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Annette Marthaler, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373,
email: CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–04013 Filed 2–24–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1600]
Draft Guidance for Industry and
Tobacco Retailers; Enforcement Policy
for Certain (Provisional) Tobacco
Products That the Food and Drug
Administration Finds Not Substantially
Equivalent; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Enforcement Policy for Certain
(Provisional) Tobacco Products That
FDA Finds Not Substantially
Equivalent.’’ This draft guidance
provides information to tobacco retailers
on FDA’s enforcement policy regarding
certain so-called provisional tobacco
products that become subject to not
substantially equivalent (NSE) orders
issued under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 28, 2014.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
the Center for Tobacco Products, Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850–
3229. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the guidance may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:58 Feb 24, 2014
Jkt 232001
I. Background
FDA is announcing the availability of
a draft guidance for tobacco retailers
entitled ‘‘Enforcement Policy for Certain
(Provisional) Tobacco Products That
FDA Finds Not Substantially
Equivalent.’’ In this draft guidance, FDA
provides information on its enforcement
policy regarding so-called provisional
tobacco products that become subject to
NSE orders under the FD&C Act. The
provisional products addressed by this
draft guidance are tobacco products that
were first introduced or delivered for
introduction into interstate commerce
for commercial distribution after
February 15, 2007, and prior to March
22, 2011, and for which a section 905(j)
(21 U.S.C. 387e(j)) (or substantial
equivalent) report was submitted no
later than March 22, 2011. Because the
FD&C Act permitted this specific group
of products to remain on the market
pending FDA’s review of the report,
there will very likely be products at
retail locations within the United States
when FDA issues an order finding a
tobacco product NSE. This draft
guidance explains that FDA does not
intend to take enforcement action for at
least 30 calendar days from the date the
NSE order issues for those products that
are in the retailer’s current inventory at
a specific retail location on the date
FDA issues the NSE order.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Enforcement Policy for Certain
(Provisional) Tobacco Products That
FDA Finds Not Substantially
Equivalent.’’ It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03978 Filed 2–24–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Loan Repayment Program for
Repayment of Health Professions
Educational Loans
Announcement Type: Initial.
CFDA Number: 93.164.
Key Dates: February 14, 2014 first
award cycle deadline date; August 15,
2014 last award cycle deadline date;
September 12, 2014 last award cycle
deadline date for supplemental loan
repayment program funds; September
30, 2014 entry on duty deadline date.
I. Funding Opportunity Description
The Indian Health Service (IHS)
estimated budget request for Fiscal Year
(FY) 2014 includes $19,090,023 for the
IHS Loan Repayment Program (LRP) for
health professional educational loans
(undergraduate and graduate) in return
for full-time clinical service as defined
in the IHS LRP policy clarifications at
https://www.ihs.gov/loanrepayment/
documents/LRP_Policy_Updates.pdf in
Indian health programs.
This program announcement is
subject to the appropriation of funds.
This notice is being published early to
coincide with the recruitment activity of
the IHS, which competes with other
Government and private health
management organizations to employ
qualified health professionals.
This program is authorized by 25
U.S.C. 1616a.
II. Award Information
The estimated amount available is
approximately $19,090,023 to support
approximately 440 competing awards
averaging $43,358 per award for a two
year contract. One year contract
extensions will receive priority
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10532-10534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04013]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0037]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Drug User Fee Act Waivers and Reductions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 10533]]
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 paperwork burden of
requesting a waiver or reduction of fees under Animal Drug User Fee Act
(ADUFA).
DATES: Submit either electronic or written comments on the collection
of information by April 28, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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 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 Fees and Fee Waivers and Reductions (OMB Control
Number 0910-0540)--Extension
Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L.
108-130) amended the Federal Food, Drug, and Cosmetic Act and requires
FDA to assess and collect user fees for certain applications, products,
establishments, and sponsors. It also requires the Agency to grant a
waiver from, or a reduction of those fees in certain circumstances.
Thus, to implement this statutory provision of ADUFA, FDA developed a
guidance entitled, ``Guidance for Industry: Animal Drug User Fees and
Fee Waivers and Reductions.'' This document provides guidance on the
types of fees FDA is authorized to collect under ADUFA, and how to
request waivers and reductions from FDA's animal drug user fees.
Further, this guidance also describes the types of fees and fee waivers
and reductions; what information FDA recommends be submitted in support
of a request for a fee waiver or reduction; how to submit such a
request; and FDA's process for reviewing requests.
Respondents to this collection of information are new animal drug
sponsors. Requests or waivers or reductions may be submitted by a
person paying any of the animal drug user fees assessed including
application fees, product fees, establishment fees, or sponsor fees.
FDA estimates the burden for this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant 45 1 time for each 45 2.............. 90
barrier to innovation. application.
740(d)(1)(B); fees exceed 8 3.75............ 30 0.5 (30 15
cost. minutes).
740(d)(1)(C); free choice 5 1 time for each 5 2.............. 10
feeds. application.
740(d)(1)(D); minor use or 76 1 time for each 76 2.............. 152
minor species. application.
740(d)(1)(E); small business. 3 1 time for each 3 2.............. 6
application.
Request for reconsideration 2 1 time for each 2 2.............. 4
of a decision. application.
Request for review (user fee 0 1 time for each 0 0.............. 0
appeal officer). application.
----------------------------------------------------------------------------------
Total.................... .............. ................ .............. ............... 277
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on FDA's database system, from fiscal year (FY) 2010 to 2012
there were an estimated 173 sponsors subject to ADUFA. However, not all
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of waiver requests is based on
the average number of submission types received by FDA in FY 2010-2012.
[[Page 10534]]
Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04013 Filed 2-24-14; 8:45 am]
BILLING CODE 4160-01-P
