82 FR 47533 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 196 (October 12, 2017)

Page Range		47533-47534
FR Document		2017-22053

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.

Federal Register, Volume 82 Issue 196 (Thursday, October 12, 2017)

[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47533-47534]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-22053]

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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

Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47533

submitting requests for reconsideration, information collections, FDA’s Center reconsideration, we estimate it will take
including details on the content and for Drug Evaluation and Research will an average of 750 total hours annually
format of the submission. Respondents receive approximately 150 requests for for respondents to prepare and submit
to the collection of information are reconsideration annually from 75 requests for reconsideration. The burden
applicants of ANDAs. Based on respondents. Because we estimate it will of the information collection, therefore,
available data with regard to similar take 5 hours to prepare a request for is estimated as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
Guidance recommendation responses per burden per
respondents responses hours
respondent response

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 DATES: Fax written comments on the identity for food ‘‘whenever . . . such
Persons with access to the Internet collection of information by November action will promote honesty and fair
may obtain the draft guidance at either 13, 2017. dealing in the interest of consumers
https://www.fda.gov/Drugs/ ADDRESSES: To ensure that comments on . . . .’’ Under section 403(g) of the
GuidanceCompliance the information collection are received, FD&C Act (21 U.S.C. 343(g)), a food that
RegulatoryInformation/Guidances/ OMB recommends that written is subject to a definition and standard of
default.htm or https://www.regulations comments be faxed to the Office of identity prescribed by regulation is
.gov. Information and Regulatory Affairs, misbranded if it does not conform to
OMB, Attn: FDA Desk Officer, Fax: 202– such definition and standard of identity.
Dated: October 5, 2017. Section 130.17 (21 CFR 130.17) provides
395–7285, or emailed to oira_
Anna K. Abram, for the issuance by FDA of temporary
submission@omb.eop.gov. All
Deputy Commissioner for Policy, Planning, comments should be identified with the marketing permits that enable the food
Legislation, and Analysis. industry to test consumer acceptance
OMB control number 0910–0133. Also
[FR Doc. 2017–22049 Filed 10–11–17; 8:45 am] include the FDA docket number found and measure the technological and
BILLING CODE 4164–01–P in brackets in the heading of this commercial feasibility in interstate
document. commerce of experimental packs of food
that deviate from applicable definitions
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: Ila and standards of identity. Section
HUMAN SERVICES Mizrachi, Office of Operations, Food 130.17(c) enables the Agency to monitor
and Drug Administration, Three White the manufacture, labeling, and
Food and Drug Administration Flint North, 10–12M, 11601 Landsdown distribution of experimental packs of
[Docket No. FDA–2011–N–0424] St., North Bethesda, MD 20852, 301– food that deviate from applicable
796–7729, PRAStaff@fda.hhs.gov. definitions and standards of identity.
Agency Information Collection SUPPLEMENTARY INFORMATION: In The information so obtained can be
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA used in support of a petition to establish
Management and Budget Review; has submitted the following proposed or amend the applicable definition or
Comment Request; Temporary collection of information to OMB for standard of identity to provide for the
Marketing Permit Applications review and clearance. variations. Section 130.17(i) specifies
AGENCY: Food and Drug Administration, Temporary Marketing Permit the information that a firm must submit
HHS. Applications—21 CFR 130.17(c) and (i) to FDA to obtain an extension of a
temporary marketing permit.
ACTION: Notice. OMB Control Number 0910–0133— In the Federal Register of June 15,
SUMMARY: The Food and Drug Extension 2017 (82 FR 27489), we published a 60-
Administration (FDA) is announcing This information collection supports day notice requesting public comment
that a proposed collection of Agency regulations. Specifically, section on the proposed extension of this
information has been submitted to the 401 of the Federal Food, Drug, and collection of information. No comments
Office of Management and Budget Cosmetic Act (the FD&C Act) (21 U.S.C. were received.
(OMB) for review and clearance under 341) directs FDA to issue regulations We therefore estimate the burden of
the Paperwork Reduction Act of 1995. establishing definitions and standards of this collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Number of Average
Number of Total annual
Activity/21 CFR section responses per burden Total hours
respondents responses
respondent per response

130.17(c)—Request for temporary marketing permit .......... 13 2 26 25 650
130.17(i)—Request to extend marketing permit .................. 1 2 2 2 4

Total .............................................................................. ........................ ........................ ........................ ........................ 654
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

VerDate Sep<11>2014 22:35 Oct 11, 2017 Jkt 244001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1

Document Created: 2018-10-25 10:06:12
Document Modified: 2018-10-25 10:06:12

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by November 13, 2017.
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, [email protected]
FR Citation		82 FR 47533

82 FR 47533 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 196 (October 12, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration