Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Framework Adjustment 19; Announcing OMB Approval of Information Collection, 39587-39588 [E8-15610]

Download as PDF 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