Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption, 34082-34083 [2011-14412]
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34082
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
Requirements for Submission of
Bioequivalence Data—21 CFR Parts 314
and 320 (OMB Control Number 0910–
0630)—Extension
In the Federal Register of January 16,
2009 (74 FR 2849), the Agency
published a final rule revising FDA
regulations to require applicants to
submit data on all BE studies, including
studies that do not meet passing
bioequivalence criteria, which are
performed on a drug product
formulation submitted for approval
under an ANDA, or in an amendment to
an ANDA that contains BE studies. In
the final rule, FDA amended
§§ 314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97, to require an
ANDA applicant to submit information
from all BE studies, both passing and
nonpassing, conducted by the applicant
on the same drug product formulation
as that submitted for approval under an
ANDA, amendment, or supplement.
In table 1 of this document, FDA has
estimated the reporting burden
associated with each section of the rule.
FDA believes that the majority of
additional BE studies will be reported in
ANDAs (submitted under § 314.94),
rather than supplements (reported in
§ 314.97), because it is unlikely than an
ANDA holder will conduct BE studies
with a drug after the drug has been
approved. With respect to the reporting
of additional BE studies in amendments
(submitted under § 314.96), this should
also account for a small number of
reports, because most BE studies will be
conducted on a drug prior to the
submission of the ANDA, and will be
reported in the ANDA itself.
FDA estimates it will require
approximately 120 hours of staff time to
prepare and submit each additional
complete BE study report, and
approximately 60 hours of staff time for
each additional BE summary report. The
Agency believes that a complete report
will be required approximately 20
percent of the time, while a summary
will suffice approximately 80 percent of
the time. Based on a weighted-average
calculation using the information
presented previously in this document,
the submission of each additional BE
study is expected to take 72 hours of
staff time ([120 × 0.2] + [60 × 0.8]).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
314.94(a)(7) .........................................................................
314.96(a)(1) .........................................................................
314.97 ..................................................................................
49
1
1
1
1
1
49
1
1
72
72
72
3,528
72
72
Total ..............................................................................
........................
........................
........................
........................
3,672
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.
notice. This notice solicits comments on
reporting requirements contained in
existing FDA regulations governing
State petitions for exemption from
preemption.
[FR Doc. 2011–14413 Filed 6–9–11; 8:45 am]
BILLING CODE 4160–01–P
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,
Room 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.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0402]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; State Petitions for
Exemption From Preemption
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
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
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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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00052
Fmt 4703
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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
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34083
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
of automated collection techniques,
when appropriate, and other forms of
information technology.
State Petitions for Exemption From
Preemption—21 CFR 100.1(d) (OMB
Control Number 0910–0277)—Extension
Under Section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (the
determine whether the State food
labeling or standard of identity
requirement satisfies the criteria of
section 403A(b) of the FD&C Act for
granting exemption from Federal
preemption.
FDA estimates the burden of this
collection of information as follows:
FD&C Act) (21 U.S.C. 343–1(b)), States
may petition FDA for exemption from
Federal preemption of State food
labeling and standard of identity
requirements. Section 100.1(d) (21 CFR
100.1(d)) sets forth the information a
State is required to submit in such a
petition. The information required
under section 100.1(d) enables FDA to
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
Total hours
100.1(d) ............................................................
1
1
1
40
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the last 3 years,
FDA has not received any new petitions
for exemption from preemption;
therefore, the Agency estimates that one
or fewer petitions will be submitted
annually. Although FDA has not
received any new petitions for
exemption from preemption in the last
3 years, it believes these information
collection provisions should be
extended to provide for the potential
future need of a State or local
government to petition for an exemption
from preemption under the provisions
of section 403(A) of the FD&C Act.
Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14412 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–2009–D–0008]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
AGENCY:
Federal Food, Drug, and Cosmetic Act’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2011–N–0401]
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Communications Usability Testing, as
Used by the Food and Drug
Administration
In the
Federal Register of December 15, 2010
(75 FR 78249) the Agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0679. The
approval expires on April 30, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14411 Filed 6–9–11; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
SUMMARY:
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Food and Drug Administration
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a generic clearance to collect
information that will provide tools to
test the usability of FDA
communications on specific topics and
to assist in the development and
modification of communication
messages to promote public health and
compliance with regulations.
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
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34082-34083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14412]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0402]
Agency Information Collection Activities; Proposed Collection;
Comment Request; State Petitions for Exemption From Preemption
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 State petitions for
exemption from preemption.
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, Room 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
[[Page 34083]]
of automated collection techniques, when appropriate, and other forms
of information technology.
State Petitions for Exemption From Preemption--21 CFR 100.1(d) (OMB
Control Number 0910-0277)--Extension
Under Section 403A(b) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for
exemption from Federal preemption of State food labeling and standard
of identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth
the information a State is required to submit in such a petition. The
information required under section 100.1(d) enables FDA to determine
whether the State food labeling or standard of identity requirement
satisfies the criteria of section 403A(b) of the FD&C Act for granting
exemption from Federal preemption.
FDA estimates the burden of this collection of information as
follows:
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1(d)................................................. 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for Sec. 100.1(d) is minimal because
petitions for exemption from preemption are seldom submitted by States.
In the last 3 years, FDA has not received any new petitions for
exemption from preemption; therefore, the Agency estimates that one or
fewer petitions will be submitted annually. Although FDA has not
received any new petitions for exemption from preemption in the last 3
years, it believes these information collection provisions should be
extended to provide for the potential future need of a State or local
government to petition for an exemption from preemption under the
provisions of section 403(A) of the FD&C Act.
Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14412 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P
