Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications, 34080-34081 [2011-14414]
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34080
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
because safety and effectiveness
information is already required by
§ 314.50 (collection of information
approved by OMB under OMB control
number 0910–0001). In fact,
clarification in these regulations of
FDA’s standards for evaluation of
diagnostic radiopharmaceuticals is
intended to streamline overall
for the preparation of the safety and
effectiveness sections of an application
that are imposed by existing regulations.
This estimate does not include the
actual time needed to conduct studies
and trials or other research from which
the reported information is obtained.
information collection burdens,
particularly for diagnostic
radiopharmaceuticals that may have
well-established, low-risk safety
profiles, by enabling manufacturers to
tailor information submissions and
avoid unnecessary clinical studies.
Table 1 of this document contains
estimates of the annual reporting burden
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
315.4, 315.5, and 315.6 ...................................
2
1
2
2,000
4,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14418 Filed 6–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0424]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Temporary
Marketing Permit Applications
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 (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
reporting requirements contained in
existing FDA regulations governing
temporary marketing permit
applications.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
Submit either electronic or
written comments on the collection of
information by August 9, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
DATES:
VerDate Mar<15>2010
14:33 Jun 09, 2011
Jkt 223001
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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.
Temporary Marketing Permit
Applications—21 CFR 130.17(c) and (i)
(OMB Control Number 0910–0133)—
Extension
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
‘‘[w]henever * * * 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
E:\FR\FM\10JNN1.SGM
10JNN1
34081
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
to FDA to obtain an extension of a
temporary marketing permit.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Average burden
per response (in
hours)
Total annual
responses
Total hours
130.17(c) ..........................................................
130.17(i) ...........................................................
13
1
2
2
26
2
25
2
650
4
Total ..........................................................
............................
............................
............................
............................
654
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary
marketing permit applications and
hours per response is an average based
on the Agency’s 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 two
temporary marketing permits per year
over the next 3 years.
Thus, FDA estimates that 13
respondents will submit two requests
for temporary marketing permits
annually under § 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 two 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: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14414 Filed 6–9–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
14:33 Jun 09, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0423]
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 (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 requirement for an abbreviated new
drug application (ANDA) applicant to
submit data from all bioequivalence
(BE) studies the applicant conducts on
a drug product formulation submitted
for approval.
DATES: Submit either electronic or
written comments on the collection of
information by August 9, 2011.
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:
Elizabeth Berbakos, Office of
Information Management, Food and
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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.
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Requirements for
Submission of Bioequivalence Data
AGENCY:
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34080-34081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14414]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0424]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Temporary Marketing Permit Applications
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
(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 reporting requirements
contained in existing FDA regulations governing temporary marketing
permit applications.
DATES: Submit either electronic or written comments on the collection
of information by August 9, 2011.
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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i) (OMB
Control Number 0910-0133)--Extension
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 ``[w]henever * * * 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
[[Page 34081]]
to FDA to obtain an extension of a temporary marketing permit.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response (in Total hours
respondents respondent responses hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
130.17(c)..................................................... 13 2 26 25 650
130.17(i)..................................................... 1 2 2 2 4
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 654
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary marketing permit applications and
hours per response is an average based on the Agency's 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 two temporary marketing
permits per year over the next 3 years.
Thus, FDA estimates that 13 respondents will submit two requests
for temporary marketing permits annually under 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 two 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: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14414 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P
