Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications, 47533-47534 [2017-22053]
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47533
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
submitting requests for reconsideration,
including details on the content and
format of the submission. Respondents
to the collection of information are
applicants of ANDAs. Based on
available data with regard to similar
information collections, FDA’s Center
for Drug Evaluation and Research will
receive approximately 150 requests for
reconsideration annually from 75
respondents. Because we estimate it will
take 5 hours to prepare a request for
reconsideration, we estimate it will take
an average of 750 total hours annually
for respondents to prepare and submit
requests for reconsideration. The burden
of the information collection, therefore,
is estimated as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance recommendation
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
Section IV: Procedures for Submitting and Responding to
a Request for Reconsideration ........................................
75
2
150
5
750
1 There
are no capital or operating and maintenance costs associated with the collection of information.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://www.regulations
.gov.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22049 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
Ila
Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10–12M, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7729, 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.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0424]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Temporary
Marketing Permit Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Fax written comments on the
collection of information by November
13, 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 0910–0133. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
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.
SUMMARY:
Temporary Marketing Permit
Applications—21 CFR 130.17(c) and (i)
OMB Control Number 0910–0133—
Extension
This information collection supports
Agency regulations. Specifically, section
401 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
341) directs FDA to issue regulations
establishing definitions and standards of
identity for food ‘‘whenever . . . such
action will promote honesty and fair
dealing in the interest of consumers
. . . .’’ Under section 403(g) of the
FD&C Act (21 U.S.C. 343(g)), a food that
is subject to a definition and standard of
identity prescribed by regulation is
misbranded if it does not conform to
such definition and standard of identity.
Section 130.17 (21 CFR 130.17) provides
for the issuance by FDA of temporary
marketing permits that enable the food
industry to test consumer acceptance
and measure the technological and
commercial feasibility in interstate
commerce of experimental packs of food
that deviate from applicable definitions
and standards of identity. Section
130.17(c) enables the Agency to monitor
the manufacture, labeling, and
distribution of experimental packs of
food that deviate from applicable
definitions and standards of identity.
The information so obtained can be
used in support of a petition to establish
or amend the applicable definition or
standard of identity to provide for the
variations. Section 130.17(i) specifies
the information that a firm must submit
to FDA to obtain an extension of a
temporary marketing permit.
In the Federal Register of June 15,
2017 (82 FR 27489), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
We therefore estimate the burden of
this collection of information as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total hours
130.17(c)—Request for temporary marketing permit ..........
130.17(i)—Request to extend marketing permit ..................
13
1
2
2
26
2
25
2
650
4
Total ..............................................................................
........................
........................
........................
........................
654
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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47534
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
The estimated number of temporary
marketing permit applications and
hours per response is an average based
on our experience with applications
received for the past 3 years, and
information from firms that have
submitted recent requests for temporary
marketing permits. Based on this
information, we estimate that there will
be, on average, approximately 13 firms
submitting requests for 2 temporary
marketing permits per year over the next
3 years.
Thus, we estimate that 13 respondents
will submit 2 requests for temporary
marketing permits annually pursuant to
§ 130.17(c). The estimated number of
respondents for § 130.17(i) is minimal
because this section is seldom used by
the respondents; therefore, the Agency
estimates that there will be one or fewer
respondents annually with two or fewer
requests for extension of the marketing
permit under § 130.17(i). The estimated
number of hours per response is an
average based on the Agency’s
experience and information from firms
that have submitted recent requests for
temporary marketing permits. We
estimate that 13 respondents each will
submit 2 requests for temporary
marketing permits under § 130.17(c) and
that it will take a respondent 25 hours
per request to comply with the
requirements of that section, for a total
of 650 hours. We estimate that one
respondent will submit two requests for
extension of its temporary marketing
permits under § 130.17(i) and that it will
take a respondent 2 hours per request to
comply with the requirements of that
section, for a total of 4 hours.
Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0113]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The Prohibition of Distributing Free
Samples of Tobacco Products;
Guidance for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘The Prohibition of Distributing
Free Samples of Tobacco Products.’’ The
SUMMARY:
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22:35 Oct 11, 2017
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The announcement of the
guidance is published in the Federal
Register on October 12, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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,
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
[FR Doc. 2017–22053 Filed 10–11–17; 8:45 am]
AGENCY:
guidance provides information intended
to assist tobacco product manufacturers,
distributors, and retailers in complying
with the regulations prohibiting the
distribution of free samples of tobacco
products.
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–D–0113 for ‘‘The Prohibition of
Distributing Free Samples of Tobacco
Products; Guidance for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
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those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the guidance
document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
E:\FR\FM\12OCN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47533-47534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0424]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Temporary Marketing
Permit Applications
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, 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 0910-0133.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7729,
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.
Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)
OMB Control Number 0910-0133--Extension
This information collection supports Agency regulations.
Specifically, section 401 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 341) directs FDA to issue regulations
establishing definitions and standards of identity for food ``whenever
. . . such action will promote honesty and fair dealing in the interest
of consumers . . . .'' Under section 403(g) of the FD&C Act (21 U.S.C.
343(g)), a food that is subject to a definition and standard of
identity prescribed by regulation is misbranded if it does not conform
to such definition and standard of identity. Section 130.17 (21 CFR
130.17) provides for the issuance by FDA of temporary marketing permits
that enable the food industry to test consumer acceptance and measure
the technological and commercial feasibility in interstate commerce of
experimental packs of food that deviate from applicable definitions and
standards of identity. Section 130.17(c) enables the Agency to monitor
the manufacture, labeling, and distribution of experimental packs of
food that deviate from applicable definitions and standards of
identity. The information so obtained can be used in support of a
petition to establish or amend the applicable definition or standard of
identity to provide for the variations. Section 130.17(i) specifies the
information that a firm must submit to FDA to obtain an extension of a
temporary marketing permit.
In the Federal Register of June 15, 2017 (82 FR 27489), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
We therefore estimate the burden of this collection of information
as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
130.17(c)--Request for temporary 13 2 26 25 650
marketing permit...............
130.17(i)--Request to extend 1 2 2 2 4
marketing permit...............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 654
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 47534]]
The estimated number of temporary marketing permit applications and
hours per response is an average based on our experience with
applications received for the past 3 years, and information from firms
that have submitted recent requests for temporary marketing permits.
Based on this information, we estimate that there will be, on average,
approximately 13 firms submitting requests for 2 temporary marketing
permits per year over the next 3 years.
Thus, we estimate that 13 respondents will submit 2 requests for
temporary marketing permits annually pursuant to Sec. 130.17(c). The
estimated number of respondents for Sec. 130.17(i) is minimal because
this section is seldom used by the respondents; therefore, the Agency
estimates that there will be one or fewer respondents annually with two
or fewer requests for extension of the marketing permit under Sec.
130.17(i). The estimated number of hours per response is an average
based on the Agency's experience and information from firms that have
submitted recent requests for temporary marketing permits. We estimate
that 13 respondents each will submit 2 requests for temporary marketing
permits under Sec. 130.17(c) and that it will take a respondent 25
hours per request to comply with the requirements of that section, for
a total of 650 hours. We estimate that one respondent will submit two
requests for extension of its temporary marketing permits under Sec.
130.17(i) and that it will take a respondent 2 hours per request to
comply with the requirements of that section, for a total of 4 hours.
Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22053 Filed 10-11-17; 8:45 am]
BILLING CODE 4164-01-P
