Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Framework Adjustment 19; Announcing OMB Approval of Information Collection, 39587-39588 [E8-15610]
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Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Rules and Regulations
Washington, DC, 20503 (Attention: ITA
Desk Officer).
Dated: July 3, 2008.
David Spooner,
Assistant Secretary for Import
Administration.
List of Subjects in 15 CFR Part 336
Imports, Quotas, Reporting and
Record-keeping, Tariffs, Textiles.
For reasons stated in the preamble, the
Interim Final Rule, which was
published on July 24, 2007 at 72 FR
40235, is adopted as final without
change.
[FR Doc. E8–15754 Filed 7–9–08; 8:45 am]
BILLING CODE 3510–DS–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
15 CFR Part 902
50 CFR Part 648
[Docket No. 070817467–8744–03]
RIN 0648–AV90
Fisheries of the Northeastern United
States; Atlantic Sea Scallop Fishery;
Framework Adjustment 19;
Announcing OMB Approval of
Information Collection
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule; effective date of OMB
control numbers.
mstockstill on PROD1PC66 with RULES
AGENCY:
SUMMARY: The National Marine
Fisheries Service (NMFS) announces
that the Office of Management and
Budget (OMB) has approved the
following collection of information
pursuant to the Paperwork Reduction
Act of 1995: OMB 0648–0546,
‘‘Northeast Region Observer Providers
Requirements.’’ This rule publishes the
OMB control number for these
collections and makes effective the
collection-of-information requirements
published in a final rule to implement
measures included in Framework
Adjustment 19 (Framework 19) to the
Atlantic Sea Scallop Fishery
Management Plan (FMP).
DATES: This final rule is effective August
11, 2008. The amendments to 50 CFR
648.11(h)(5)(vii)(G) through (J), and the
collection-of-information requirements
published on May 29, 2008 (73 FR
30790), are effective August 11, 2008.
ADDRESSES: An environmental
assessment (EA) was prepared for
VerDate Aug<31>2005
16:54 Jul 09, 2008
Jkt 214001
Framework 19 that describes the action
and other alternatives considered, and
provides a thorough analysis of the
impacts of the measures and
alternatives. Copies of Framework 19,
the EA, and the Initial Regulatory
Flexibility Analysis (IRFA), are
available upon request from Paul J.
Howard, Executive Director, New
England Fishery Management Council
(Council), 50 Water Street,
Newburyport, MA 01950. The Final
Regulatory Flexibility Analysis (FRFA)
was published in the Classification
section of the final rule (73 FR 30790,
May 29, 2008). Copies of the FRFA are
available upon request from the
Regional Administrator at the address
listed in the next paragraph.
Written comments regarding the
burden-hour estimates or other aspects
of the collection-of-information
requirements contained in this final rule
may be submitted to the Regional
Administrator at 1 Blackburn Drive,
Gloucester, MA 01930 and by e-mail to
DavidlRostker@omb.eop.gov, or fax to
(202) 395–7285.
FOR FURTHER INFORMATION CONTACT:
Jamie Goen, Fishery Policy Analyst,
phone 978–281–9220; fax 978–281–
9135.
SUPPLEMENTARY INFORMATION: On May
29, 2008 (73 FR 30790), NMFS
published a final rule to implement
measures included in Framework
Adjustment 19 (Framework 19) to the
Atlantic Sea Scallop Fishery
Management Plan (FMP), which was
developed by the Council. Framework
19 included, in part, adjustments to the
industry-funded observer program for
the scallop fishery, which included a
collection of information associated
with regulations at 50 CFR
648.11(h)(5)(vii)(G) through (J). OMB’s
approval of NMFS PRA submission on
the collection of information did not
happen in time to publish their
determination with the final rule on
Framework 19.
The PRA and its implementing
regulations require Federal agencies to
display OMB control numbers and
inform respondents of their legal
significance after OMB has approved an
Agency’s information collection. An
agency may not conduct or sponsor a
collection of information unless it
displays a currently valid OMB control
number, and no person is required to
respond to a collection of information
unless it displays a currently valid OMB
control number. In accordance with the
requirements of the PRA and its
implementing regulations, NMFS
notifies the public that the following
information collection has been
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
39587
approved by OMB following the
Agency’s submission of an information
collection request (ICR):
OMB Control Number: 0648–0546.
OMB Approval Date: 06/03/08.
Expiration Date: 06/30/2011.
Title: Northeast Region Observer
Providers Requirements.
This notice announces approval of the
information collection listed above,
publishes the OMB control number, and
announces the effectiveness of the
implementing regulations in 50 CFR
648.11(h)(5)(vii)(G) through (J).
Classification
NMFS determined that Framework 19
was necessary for the conservation and
management of the Atlantic sea scallop
fishery and was consistent with the
Magnuson-Stevens Act and other
applicable law. This rule announces
OMB approval of a collection of
information pursuant to the PRA and
the effectiveness of regulations that
were published in the final rule for
Framework 19 dated May 29, 2008.
Therefore, NMFS has also determined
that this rule is necessary for the
conservation and management of the
Atlantic sea scallop fishery and is
consistent with the Magnuson-Stevens
Act and other applicable law.
This final rule has been determined to
be not significant for purposes of
Executive Order 12866.
This rule contains a collection-ofinformation requirement subject to the
PRA. The collection of this information
was approved by OMB on June 3, 2008,
under OMB Control Number 0648–0546.
Public reporting burden for these
collections of information are estimated
to average as follows:
1. Service provider observer contact
information reports, OMB # 0648–
0546—5 min per response;
2. Service provider observer
availability reports, OMB # 0648–
0546—1 min per response;
3. Copies of service provider outreach
materials, OMB # 0648–0546—30 min
per response;
4. Copies of service provider
contracts, OMB # 0648–0546 —30 min
per response.
More detail on these collections of
information is available in the final rule
for Framework 19 (73 FR 30790, May
29, 2008) and on the following website
listing OMB approved PRA
submissions: https://www.cio.noaa.gov/
itmanagement/prasubs.html. Send
comments regarding these burden
estimates or any other aspect of this data
collection, including suggestions for
reducing the burden, to NMFS (see
ADDRESSES) and by e-mail to
E:\FR\FM\10JYR1.SGM
10JYR1
39588
Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Rules and Regulations
DavidlRostker@omb.eop.gov, or fax to
202–395–7285.
NMFS, pursuant to Section 604 of the
Regulatory Flexibility Act (RFA),
included a final regulatory flexibility
analysis (FRFA) in the classification
section of the Framework 19 final rule.
This final rule only announces OMB
approval of a collection of information
and effectiveness of regulations
contained in the Framework 19 final
rule and analyses. Therefore, the FRFA
is not repeated here. The FRFA
described the economic impact the
Framework 19 final rule will have on
small entities. It incorporated the
economic impacts and analysis
summarized in the IRFA for the
proposed rule to implement Framework
19, the comments and responses in the
Framework 19 final rule, and the
corresponding economic analyses
prepared for Framework 19 (e.g., the EA
and the RIR). A copy of the IRFA, the
RIR, and the EA for Framework 19 is
available upon request (see ADDRESSES).
CFR part or section where the
information collection requirement is located
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 312, 314, 600, and 601
[Docket No. FDA–2004–N–0510] (formerly
Docket No. 2004N–0267)
Applications for Approval to Market a
New Drug; Complete Response Letter;
Amendments to Unapproved
Applications
Reporting and recordkeeping.
ACTION:
For the reasons stated in the preamble,
15 CFR part 902 is amended as follows:
I
PART 902—NOAA INFORMATION
COLLECTION REQUIREMENTS UNDER
THE PAPERWORK REDUCTION ACT:
OMB CONTROL NUMBERS
1. The authority citation for part 902
continues to read as follows:
Authority: 44 U.S.C. 3501 et seq.
2. In § 902.1, the table in paragraph (b)
under ‘‘50 CFR’’ is amended by revising
the existing entry for § 648.11 to read as
follows:
I
§ 902.1 OMB control numbers assigned
pursuant to the Paperwork Reduction Act.
*
CFR part or section where the
information collection requirement is located
mstockstill on PROD1PC66 with RULES
*
Current OMB
control number (All numbers begin
with 0648–)
*
*
*
*
50 CFR
*
*
*
*
*
648.11
VerDate Aug<31>2005
–0202,–0546,
and –0555
17:17 Jul 09, 2008
Jkt 214001
Food and Drug Administration,
HHS.
Dated: July 2, 2008.
John Oliver,
Deputy Assistant Administrator For
Operations, National Marine Fisheries
Service.
*
*
BILLING CODE 3510–22–S
AGENCY:
*
*
(b) Display.
*
[FR Doc. E8–15610 Filed 7–9–08; 8:45 am]
List of Subjects in 15 CFR Part 902
*
*
Current OMB
control number (All numbers begin
with 0648–)
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations on new drug applications
(NDAs) and abbreviated new drug
applications (ANDAs) for approval to
market new drugs and generic drugs
(drugs for which approval is sought in
an ANDA). The final rule discontinues
FDA’s use of approvable letters and not
approvable letters when taking action
on marketing applications. Instead, we
will send applicants a complete
response letter to indicate that the
review cycle for an application is
complete and that the application is not
ready for approval. We are also revising
the regulations on extending the review
cycle due to the submission of an
amendment to an unapproved
application and starting a new review
cycle after the resubmission of an
application following receipt of a
complete response letter. In addition,
we are adding to the regulations on
biologics license applications (BLAs)
provisions on the issuance of complete
response letters to BLA applicants. We
are taking these actions to implement
the user fee performance goals
referenced in the Prescription Drug User
Fee Amendments of 2002 (PDUFA III)
that address procedures and establish
target timeframes for reviewing human
drug applications.
DATES: This rule is effective August 11,
2008.
FOR FURTHER INFORMATION CONTACT:
Brian L. Pendleton, Center for Drug
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6304,
Silver Spring, MD 20993, 301–796–
3504; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. The Proposed Rule
B. Changes to the Proposed Rule
II. Summary of the Final Rule
A. Complete Response Letters
B. Resubmissions
C. Amendments to Unapproved
Applications
III. Comments on the Proposed Rule
A. General Comments
B. Definitions (Proposed § 314.3(b))
C. Timeframes for Review (Proposed
§ 314.100)
D. Complete Response Letters (Proposed
§ 314.110)
E. Complete Response Letters for BLAs
F. Miscellaneous Provisions Related to
Complete Response Letters
G. Amendments to NDAs (Proposed
§ 314.60)
H. Amendments to ANDAs (Proposed
§ 314.96)
IV. Analysis of Economic Impacts
A. Impact of the Final Rule
B. Summary of Impacts
C. Comments
D. Conclusion
V. Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
I. Background
In the Federal Register of July 20,
2004 (69 FR 43351), we published a
proposed rule to replace approvable and
not approvable letters with complete
response letters and to make other
changes to our regulations on NDAs,
ANDAs, and BLAs. Previous § 314.110
(21 CFR 314.110) set forth provisions on
the issuance of and response to
approvable letters; § 314.120 (21 CFR
314.120) addressed the issuance of and
response to not approvable letters. The
proposed rule proposed to replace those
provisions with a revised § 314.110
regarding the issuance of complete
response letters upon completion of our
review of NDAs and ANDAs.
A. The Proposed Rule
The preamble to the proposed rule
stated that the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) agreed to revise their
regulations and procedures to provide
for the issuance of complete response
letters as part of our prescription drug
E:\FR\FM\10JYR1.SGM
10JYR1
]]>Agencies
[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Rules and Regulations]
[Pages 39587-39588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15610]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
15 CFR Part 902
50 CFR Part 648
[Docket No. 070817467-8744-03]
RIN 0648-AV90
Fisheries of the Northeastern United States; Atlantic Sea Scallop
Fishery; Framework Adjustment 19; Announcing OMB Approval of
Information Collection
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Final rule; effective date of OMB control numbers.
-----------------------------------------------------------------------
SUMMARY: The National Marine Fisheries Service (NMFS) announces that
the Office of Management and Budget (OMB) has approved the following
collection of information pursuant to the Paperwork Reduction Act of
1995: OMB 0648-0546, ``Northeast Region Observer Providers
Requirements.'' This rule publishes the OMB control number for these
collections and makes effective the collection-of-information
requirements published in a final rule to implement measures included
in Framework Adjustment 19 (Framework 19) to the Atlantic Sea Scallop
Fishery Management Plan (FMP).
DATES: This final rule is effective August 11, 2008. The amendments to
50 CFR 648.11(h)(5)(vii)(G) through (J), and the collection-of-
information requirements published on May 29, 2008 (73 FR 30790), are
effective August 11, 2008.
ADDRESSES: An environmental assessment (EA) was prepared for Framework
19 that describes the action and other alternatives considered, and
provides a thorough analysis of the impacts of the measures and
alternatives. Copies of Framework 19, the EA, and the Initial
Regulatory Flexibility Analysis (IRFA), are available upon request from
Paul J. Howard, Executive Director, New England Fishery Management
Council (Council), 50 Water Street, Newburyport, MA 01950. The Final
Regulatory Flexibility Analysis (FRFA) was published in the
Classification section of the final rule (73 FR 30790, May 29, 2008).
Copies of the FRFA are available upon request from the Regional
Administrator at the address listed in the next paragraph.
Written comments regarding the burden-hour estimates or other
aspects of the collection-of-information requirements contained in this
final rule may be submitted to the Regional Administrator at 1
Blackburn Drive, Gloucester, MA 01930 and by e-mail to David_
Rostker@omb.eop.gov, or fax to (202) 395-7285.
FOR FURTHER INFORMATION CONTACT: Jamie Goen, Fishery Policy Analyst,
phone 978-281-9220; fax 978-281-9135.
SUPPLEMENTARY INFORMATION: On May 29, 2008 (73 FR 30790), NMFS
published a final rule to implement measures included in Framework
Adjustment 19 (Framework 19) to the Atlantic Sea Scallop Fishery
Management Plan (FMP), which was developed by the Council. Framework 19
included, in part, adjustments to the industry-funded observer program
for the scallop fishery, which included a collection of information
associated with regulations at 50 CFR 648.11(h)(5)(vii)(G) through (J).
OMB's approval of NMFS PRA submission on the collection of information
did not happen in time to publish their determination with the final
rule on Framework 19.
The PRA and its implementing regulations require Federal agencies
to display OMB control numbers and inform respondents of their legal
significance after OMB has approved an Agency's information collection.
An agency may not conduct or sponsor a collection of information unless
it displays a currently valid OMB control number, and no person is
required to respond to a collection of information unless it displays a
currently valid OMB control number. In accordance with the requirements
of the PRA and its implementing regulations, NMFS notifies the public
that the following information collection has been approved by OMB
following the Agency's submission of an information collection request
(ICR):
OMB Control Number: 0648-0546.
OMB Approval Date: 06/03/08.
Expiration Date: 06/30/2011.
Title: Northeast Region Observer Providers Requirements.
This notice announces approval of the information collection listed
above, publishes the OMB control number, and announces the
effectiveness of the implementing regulations in 50 CFR
648.11(h)(5)(vii)(G) through (J).
Classification
NMFS determined that Framework 19 was necessary for the
conservation and management of the Atlantic sea scallop fishery and was
consistent with the Magnuson-Stevens Act and other applicable law. This
rule announces OMB approval of a collection of information pursuant to
the PRA and the effectiveness of regulations that were published in the
final rule for Framework 19 dated May 29, 2008. Therefore, NMFS has
also determined that this rule is necessary for the conservation and
management of the Atlantic sea scallop fishery and is consistent with
the Magnuson-Stevens Act and other applicable law.
This final rule has been determined to be not significant for
purposes of Executive Order 12866.
This rule contains a collection-of-information requirement subject
to the PRA. The collection of this information was approved by OMB on
June 3, 2008, under OMB Control Number 0648-0546. Public reporting
burden for these collections of information are estimated to average as
follows:
1. Service provider observer contact information reports, OMB
0648-0546--5 min per response;
2. Service provider observer availability reports, OMB
0648-0546--1 min per response;
3. Copies of service provider outreach materials, OMB
0648-0546--30 min per response;
4. Copies of service provider contracts, OMB 0648-0546 --
30 min per response.
More detail on these collections of information is available in the
final rule for Framework 19 (73 FR 30790, May 29, 2008) and on the
following website listing OMB approved PRA submissions: https://
www.cio.noaa.gov/itmanagement/prasubs.html. Send comments regarding
these burden estimates or any other aspect of this data collection,
including suggestions for reducing the burden, to NMFS (see ADDRESSES)
and by e-mail to
[[Page 39588]]
David_Rostker@omb.eop.gov, or fax to 202-395-7285.
NMFS, pursuant to Section 604 of the Regulatory Flexibility Act
(RFA), included a final regulatory flexibility analysis (FRFA) in the
classification section of the Framework 19 final rule. This final rule
only announces OMB approval of a collection of information and
effectiveness of regulations contained in the Framework 19 final rule
and analyses. Therefore, the FRFA is not repeated here. The FRFA
described the economic impact the Framework 19 final rule will have on
small entities. It incorporated the economic impacts and analysis
summarized in the IRFA for the proposed rule to implement Framework 19,
the comments and responses in the Framework 19 final rule, and the
corresponding economic analyses prepared for Framework 19 (e.g., the EA
and the RIR). A copy of the IRFA, the RIR, and the EA for Framework 19
is available upon request (see ADDRESSES).
List of Subjects in 15 CFR Part 902
Reporting and recordkeeping.
Dated: July 2, 2008.
John Oliver,
Deputy Assistant Administrator For Operations, National Marine
Fisheries Service.
0
For the reasons stated in the preamble, 15 CFR part 902 is amended as
follows:
PART 902--NOAA INFORMATION COLLECTION REQUIREMENTS UNDER THE
PAPERWORK REDUCTION ACT: OMB CONTROL NUMBERS
1. The authority citation for part 902 continues to read as
follows:
Authority: 44 U.S.C. 3501 et seq.
0
2. In Sec. 902.1, the table in paragraph (b) under ``50 CFR'' is
amended by revising the existing entry for Sec. 648.11 to read as
follows:
Sec. 902.1 OMB control numbers assigned pursuant to the Paperwork
Reduction Act.
* * * * *
(b) Display.
------------------------------------------------------------------------
Current OMB control number
CFR part or section where the information (All numbers begin with 0648-
collection requirement is located )
------------------------------------------------------------------------
* * * * *
50 CFR .............................
* * * * *
648.11 -0202,-0546, and -0555
* * * * *
------------------------------------------------------------------------
[FR Doc. E8-15610 Filed 7-9-08; 8:45 am]
BILLING CODE 3510-22-S
