Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements, 61643-61644 [2014-24293]
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61643
Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Title Amendments ............................................................................................
State TANF plan ..............................................................................................
18
18
1
1
3
30
54
540
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
594
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2014–N–0801]
mstockstill on DSK4VPTVN1PROD with NOTICES
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:
Exports: Notification and
Recordkeeping Requirements—21 CFR
1.101 (OMB Control Number 0910–
0482)—Extension
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
Food and Drug Administration,
HHS.
16:59 Oct 10, 2014
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 November
13, 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 0910–0482. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
BILLING CODE 4184–01–P
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Notice.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–24329 Filed 10–10–14; 8:45 am]
AGENCY:
ACTION:
Jkt 235001
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,
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
cosmetics, and tobacco products that are
not to 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 marketed 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).
In the Federal Register of July 3, 2014
(79 FR 38036), 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\14OCN1.SGM
14OCN1
61644
Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
1.101(d) (Non-Tobacco products) ........................................
1 There
Number of
responses per
respondent
73
Total annual
responses
503
Average
burden per
response
36,719
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 BURDEN 1
21 CFR section
Number of
recordkeepers
Number 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
........................
........................
........................
........................
35,706
Total ..............................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24293 Filed 10–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1351]
Flow Cytometric Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Flow Cytometric Devices.’’
This draft guidance addresses the
current major review concerns regarding
submissions for flow cytometric devices
used as in vitro diagnostic devices for
leukocyte immunophenotyping and
provides suggestions on the content of
submissions for these types of devices.
This draft guidance is not final nor is it
in effect at this time.
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 of 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 January 12,
2015.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
An electronic copy of the
guidance document is available for
download from the Internet. See the
ADDRESSES:
VerDate Sep<11>2014
16:59 Oct 10, 2014
Jkt 235001
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Flow Cytometric
Devices’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002, or Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
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.
FOR FURTHER INFORMATION CONTACT:
Kevin Maher, Office of In Vitro
Diagnostics and Radiological Health,
Center for Devices and Radiological
Health (CDRH), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4246, Silver Spring,
MD 20993–0002, 301–796–6879, or
Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
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Fmt 4703
Sfmt 4703
I. Background
This draft guidance addresses certain
issues that arise in premarket
submissions for flow cytometric devices
used as in vitro diagnostic devices for
leukocyte immunophenotyping and
provides suggestions on the content of
submissions for these types of devices.
It is intended to be used in conjunction
with the other cited guidance
documents referenced therein. In
preparing your submission to FDA, we
recommend that you contact FDA’s
Office of In Vitro Diagnostics and
Radiological Health (see FOR FURTHER
INFORMATION CONTACT) for additional
information regarding your submission.
This draft guidance focuses on issues
relevant to flow cytometric devices with
an expanded scope of review topics that
reflect the recognition of a flow
cytometric device as an analytical
system, which includes processing
reagents, processing instrumentation,
flow cytometers, and analytical
software, in addition to the monoclonal
antibody (mAb) component. The
information presented in this draft
guidance is based on the following: (1)
Current basic science, (2) clinical
experience, and (3) previous
submissions by manufacturers to FDA.
As advances are made in science and
medicine, the content of this guidance
will be re-evaluated and revised as
necessary to accommodate new
knowledge.
This draft guidance is directed toward
immunophenotyping of leukocytes
using mAbs. However, the concepts may
be applicable to related devices that
utilize fluorochromes or fluorogenic
substrates to measure ligand binding on
solid particles in suspension, with or
without mAbs. This draft guidance does
not cover microscopy devices utilizing
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]]>Agencies
[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61643-61644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24293]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0801]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exports: Notification
and Recordkeeping Requirements
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
November 13, 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 0910-0482.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
that are not to 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 marketed 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).
In the Federal Register of July 3, 2014 (79 FR 38036), 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 61644]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(b), (c), and (e) (Non-Tobacco Products )..................... 320 3 960 22 21,120
1.101(b) (Non-Tobacco Products for Office of International Programs 1 189 189 22 4,158
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: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24293 Filed 10-10-14; 8:45 am]
BILLING CODE 4164-01-P
