Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements, 38036-38037 [2014-15647]
Download as PDF
<![CDATA[
38036
Federal Register / Vol. 79, No. 128 / Thursday, July 3, 2014 / Notices
facilitate any communication that may be
necessary between the parties prior to the
hearing, please notify the presiding officer to
indicate acceptability of the hearing date that
has been scheduled and provide names of the
individuals who will represent the state at
the hearing.
Sincerely,
Marilyn Tavenner,
Administrator.
Section 1116 of the Social Security Act
(42 U.S.C. section 1316; 42 CFR section
430.18)
(Catalog of Federal Domestic Assistance
program No. 13.714, Medicaid Assistance
Program.)
Dated: June 27, 2014.
Marilyn Tavenner,
Administrator, Center for Medicare &
Medicaid Services.
[FR Doc. 2014–15615 Filed 7–2–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0801]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
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
(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
export notification and recordkeeping
requirements for persons exporting
human drugs, biological products,
devices, animal drugs, food, cosmetics,
and tobacco that may not be marketed
or sold in the United States.
DATES: Submit either electronic or
written comments on the collection of
information by September 2, 2014.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:53 Jul 02, 2014
Jkt 232001
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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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.
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Exports: Notification and
Recordkeeping Requirements—21 CFR
1.101 (OMB Control Number 0910–
0482)—Extension
Section 801 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 381) charges the Secretary of
Health and Human Services, through
FDA, with the responsibility of assuring
exports (Exports: Notification and
Recordkeeping Requirements—§ 1.101
(21 CFR 1.101)) which pertain to the
exportation of unapproved new drugs,
biologics, devices, animal drugs, food,
cosmetics, and tobacco products are not
be sold in the United States.
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or markets in the United States as
allowed under section 801(e) of the
FD&C Act. In general, the notification
identifies the product being exported
(e.g. name, description, and in some
cases, country of destination) and
specifies where the notifications were
sent. These notifications are sent only
for an initial export. Subsequent exports
of the same product to the same
destination or in the case of certain
countries identified in section 802(b) of
the FD&C Act (21 U.S.C. 382) would not
result in a notification to FDA.
The recordkeepers to this information
collection are exporters who export
human drugs, biologics, devices, animal
drugs, foods, cosmetics, and tobacco
products that may not be sold in the
United States and maintain records
demonstrating their compliance with
the requirements in section 801(e)(1) of
the FD&C Act.
On March 30, 2012, OMB approved
‘‘Further Amendments to General
Regulations of the Food and Drug
Administration to Incorporate Tobacco
Products,’’ OMB control number 0910–
0690, which amended, among other
sections, § 1.101 to incorporate tobacco
products. This amendment reflects the
Agency’s authority over tobacco
products under the Family Smoking
Prevention and Tobacco Control Act
(Pub. L. 111–31) and added tobacco
products to the list of products covered
under § 1.101(a) and (b).
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\03JYN1.SGM
03JYN1
38037
Federal Register / Vol. 79, No. 128 / Thursday, July 3, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
21 CFR section
1.101(d) (Non-Tobacco products) ........................................
1 There
No. of
responses
per
respondent
73
Total
annual
responses
503
36,719
Average
burden per
response
15
Total
hours
550,785
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
recordkeepers
21 CFR section
No. of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
1.101(b), (c), and (e) (Non-Tobacco Products) ...................
1.101(b) (Non-Tobacco Products for Office of International
Programs only) .................................................................
1.101(b) (Tobacco Products Only) ......................................
320
3
960
22
21,120
1
158
189
3
189
474
22
22
4,158
10,428
Total ..............................................................................
........................
........................
........................
........................
35,706
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
title ‘‘Antiparasitic Drug Use and
Antiparasitic Resistance Survey.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2014–15647 Filed 7–2–14; 8:45 am]
BILLING CODE 4164–01–P
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0307]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Antiparasitic Drug
Use and Antiparasitic Resistance
Survey
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
(the PRA).
DATES: Fax written comments on the
collection of information by August 4,
2014.
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–NEW and
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:53 Jul 02, 2014
Jkt 232001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Antiparasitic Drug Use and
Antiparasitic Resistance Survey—21
CFR 514.4 (OMB Control Number—
0910–NEW)
Resistance of parasites to one or more
of the major classes of FDA-approved
antiparasitic drugs is a documented
problem in cattle, horses, sheep, and
goats in the United States. The results
from this survey will provide FDA
information that can be used to make
decisions about future approaches to
antiparasitic drugs. FDA will make the
results of the survey publicly available.
FDA’s Center for Veterinary Medicine
(CVM) plans to survey members of
veterinary professional organizations
using an Internet-based survey
instrument. The questions in the survey
are designed to elicit professional
opinions regarding the use of
antiparasitic drugs and the awareness of
antiparasitic drug resistance. The survey
will query subjects on topics including:
(1) Awareness of the issues related to
antiparasitic drug resistance; (2)
methods currently being used to detect
and/or monitor for antiparasitic drug
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
resistance; (3) management practices
being used or recommended to manage
or reduce antiparasitic drug resistance;
and (4) labeling and marketing
considerations for antiparasitic drugs.
In the Federal Register of December 3,
2012 (77 FR 71603), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received several
comments in response to the notice,
which are discussed below.
(Comment) The first comment stated
that the collection is not necessary for
the proper performance of FDA’s
functions.
(CVM Response) We disagree. The
mission of the Office of New Animal
Drug Evaluation within CVM is to
expeditiously approve safe and
effective, properly labeled, quality
manufactured new animal drugs
through a science-based approach in a
regulatory environment. This collection
is necessary for the proper performance
of FDA/CVM’s mission because it will
help us gather information that can be
used to appropriately label antiparasitic
drugs and, thereby, enhance the
sustainability and continued availability
of approved antiparasitic drugs.
(Comment) Another comment stated
that while assessing the current
situation in the field is important, the
information to be gained from the
survey will have little practical utility
because the data will be of opinions
held by an extremely small sample size.
(CVM Response) The target
population for this survey is the subset
of veterinarians and parasitologists who
have a direct opportunity to observe and
assess the antiparasitic resistance issues
in the field. CVM understands that a
part of the target population, namely
E:\FR\FM\03JYN1.SGM
03JYN1
]]>Agencies
[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Notices]
[Pages 38036-38037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15647]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0801]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports: Notification and Recordkeeping Requirements
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
(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 export notification and recordkeeping
requirements for persons exporting human drugs, biological products,
devices, animal drugs, food, cosmetics, and tobacco that may not be
marketed or sold in the United States.
DATES: Submit either electronic or written comments on the collection
of information by September 2, 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
Exports: Notification and Recordkeeping Requirements--21 CFR 1.101 (OMB
Control Number 0910-0482)--Extension
Section 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 381) charges the Secretary of Health and Human
Services, through FDA, with the responsibility of assuring exports
(Exports: Notification and Recordkeeping Requirements--Sec. 1.101 (21
CFR 1.101)) which pertain to the exportation of unapproved new drugs,
biologics, devices, animal drugs, food, cosmetics, and tobacco products
are not be sold in the United States.
The respondents to this information collection are exporters who
have notified FDA of their intent to export unapproved products that
may not be sold or markets in the United States as allowed under
section 801(e) of the FD&C Act. In general, the notification identifies
the product being exported (e.g. name, description, and in some cases,
country of destination) and specifies where the notifications were
sent. These notifications are sent only for an initial export.
Subsequent exports of the same product to the same destination or in
the case of certain countries identified in section 802(b) of the FD&C
Act (21 U.S.C. 382) would not result in a notification to FDA.
The recordkeepers to this information collection are exporters who
export human drugs, biologics, devices, animal drugs, foods, cosmetics,
and tobacco products that may not be sold in the United States and
maintain records demonstrating their compliance with the requirements
in section 801(e)(1) of the FD&C Act.
On March 30, 2012, OMB approved ``Further Amendments to General
Regulations of the Food and Drug Administration to Incorporate Tobacco
Products,'' OMB control number 0910-0690, which amended, among other
sections, Sec. 1.101 to incorporate tobacco products. This amendment
reflects the Agency's authority over tobacco products under the Family
Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) and added
tobacco products to the list of products covered under Sec. 1.101(a)
and (b).
FDA estimates the burden of this collection of information as
follows:
[[Page 38037]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of Average
21 CFR section No. of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
1.101(d) (Non-Tobacco products). 73 503 36,719 15 550,785
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Average
21 CFR section No. of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
1.101(b), (c), and (e) (Non- 320 3 960 22 21,120
Tobacco Products)..............
1.101(b) (Non-Tobacco Products 1 189 189 22 4,158
for Office of International
Programs only).................
1.101(b) (Tobacco Products Only) 158 3 474 22 10,428
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 35,706
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15647 Filed 7-2-14; 8:45 am]
BILLING CODE 4164-01-P
