Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption, 46269-46270 [2014-18640]
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Federal Register / Vol. 79, No. 152 / Thursday, August 7, 2014 / Notices
In
accordance with Section 2607(b)(1) of
the Low Income Home Energy
Assistance Act (the Act), Title XXVI of
the Omnibus Budget Reconciliation Act
of 1981 (42 U.S.C. 8621, et seq.), as
amended, a notice was published in the
Federal Register on January 14, 2014
announcing the Secretary’s preliminary
determination that $2,192,230 of FFY
2013 funds for the Low Income Home
Energy Assistance Program (LIHEAP)
may be available for reallotment.
Subsequent to the publication of this
notice, two additional grantees reported
$8,688,313 of funds for reallotment.
Thus, a total of $10,880,543 was
reported by grantees as available for
reallotment from FY 2013.
These funds became available from
the following grantees:
SUPPLEMENTARY INFORMATION:
REALLOTMENT AMOUNTS OF FFY 2013
LIHEAP FUNDS
Grantee name
FY 2013 Reallotment amount
State of Nebraska .........
State of South Carolina
State of Utah ................
Delaware Tribe of Indians ............................
Salt River Pima-Maricopa Indian Community .............................
$2,180,356.00
7,358,414.00
1,329,899.00
Total .......................
10,880,543.00
9,793.00
2,081.00
Pursuant to the statute cited above,
these funds were reallotted on June 17,
2014 to all current LIHEAP grantees by
distributing the total reallotted funds
under the formula Congress set for FFY
2014 funding. The only exception is that
grantees whose allocations would have
been less than $25 did not receive an
award.
The reallotted funds may be used for
any purpose authorized under LIHEAP.
Grantees must add these funds to their
total LIHEAP funds payable for FFY
2014 for purposes of calculating
statutory caps on administrative costs,
carryover, assurance 16 activities, and
weatherization assistance.
Statutory Authority: 45 CFR 96.81 and 42
U.S.C. 8621 et seq.
Jeannie Chaffin,
Director, Office of Community Services.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1104]
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 our
proposed collection of certain
information. 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 invites comments on
the information collection provisions of
our reporting requirements contained in
existing FDA regulations governing state
petitions for exemption from
preemption.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by October 6, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
DATES:
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
SUPPLEMENTARY INFORMATION:
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46269
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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
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 our 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.
State Petitions for Exemption From
Preemption—21 CFR 100.1(d) (OMB
Control No. 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 § 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.
We estimate the burden of this
collection of information as follows:
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46270
Federal Register / Vol. 79, No. 152 / Thursday, August 7, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR 100.1(d)
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Form of petition ....................................................................
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,
we have received one new petition for
exemption from preemption; therefore,
we estimate that one or fewer petitions
will be submitted annually.
Dated: August 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
control number 0910–0621. The
approval expires on July 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: July 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18600 Filed 8–6–14; 8:45 am]
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BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1027]
Food and Drug Administration
[Docket No. FDA–2011–N–0017]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Voluntary National Retail Food
Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Voluntary National Retail Food
Regulatory Program Standards’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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.
SUMMARY:
On May
29, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Voluntary National Retail
Food Regulatory Program Standards’’ 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
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SUPPLEMENTARY INFORMATION:
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Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Recall Regulations
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
information collection provisions in
FDA’s infant formula recall regulations.
DATES: Submit either electronic or
written comments on the collection of
information by October 6, 2014.
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.
SUMMARY:
PO 00000
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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: 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.
FOR FURTHER INFORMATION CONTACT:
Infant Formula Recall Regulations—21
CFR 107.230, 107.240, 107.250, 107.260,
and 107.280 (OMB Control Number
0910–0188)—Extension
Section 412(e) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 350a(e)) provides that if the
manufacturer of an infant formula has
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[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46269-46270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18640]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1104]
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 our proposed collection of certain
information. 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
invites comments on the information collection provisions of our
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 October 6, 2014.
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: 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: 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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
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 our 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.
State Petitions for Exemption From Preemption--21 CFR 100.1(d) (OMB
Control No. 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 Sec. 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.
We estimate the burden of this collection of information as
follows:
[[Page 46270]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR 100.1(d) Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form of petition................................................... 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, we have received one new petition for exemption
from preemption; therefore, we estimate that one or fewer petitions
will be submitted annually.
Dated: August 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18640 Filed 8-6-14; 8:45 am]
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