Agency Information Collection Activities: Submission for OMB Review; Comment Request, 794-796 [E6-22576]

Download as PDF 794 Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Felix Frueh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4512, Silver Spring, MD 20993–0002, 301–796–1530; or Raj K. Puri, Center for Biologics Evaluation and Research (HFM– 735), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–0471. Regarding the ICH: Michelle Limoli, Office of International Programs (HFG–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4480. SUPPLEMENTARY INFORMATION: jlentini on PROD1PC65 with NOTICES I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industries Associations, the Japanese Ministry of Health, Labour, and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). VerDate Aug<31>2005 17:57 Jan 05, 2007 Jkt 211001 The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In October 2006, the ICH Steering Committee agreed that a draft guidance entitled ‘‘E15 Terminology in Pharmacogenomics’’ should be made available for public comment. The draft guidance is the product of the E15 Pharmacogenomics Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the E15 Pharmacogenomics Expert Working Group. The draft guidance represents an international effort to harmonize pharmacogenomics definitions and sample coding. Inconsistent definitions make it difficult to achieve agreement on parameters for implementation of pharmacogenomics in global pharmaceutical development, and might lead to inconsistent assessments by regulators. The draft guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. Timely harmonisation of terminology and definitions will create a common foundation for future guidance on pharmacogenomics. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at http:// PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 www.fda.gov/ohrms/dockets/ default.htm, http://www.fda.gov/cder/ guidance/index.htm, or http:// www.fda.gov/cber/publications.htm. Dated: December 29, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–5 Filed 1–5–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Proposed Project: GPRA Client Outcomes for the Substance Abuse and Mental Health Services Administration (SAMHSA)—(OMB No. 0930–0208)— Revision. The mission of the Substance Abuse and Mental Health Services Administration (SAMHSA) is to improve the effectiveness and efficiency of substance abuse and mental health treatment and prevention services across the United States. All of SAMHSA’s activities are designed to ultimately reduce the gap in the availability of substance abuse and mental health services and to improve their effectiveness and efficiency. Data are collected from all SAMHSA discretionary services grants and contracts where client/participant outcomes are to be assessed at three points (for the Center for Substance Abuse Treatment (CSAT): Intake, discharge, and post-intake and for the Center for Substance Abuse Prevention (CSAP): pre-intervention, postintervention, and follow-up). SAMHSAfunded projects are required to submit these data as a contingency of their award. The analysis of the data also will help determine whether the goal of reducing health and social costs of drug use to the public is being achieved. The primary purpose of this data collection activity is to meet the reporting requirements of the Government Performance and Results Act (GPRA) by allowing SAMHSA to quantify the effects and E:\FR\FM\08JAN1.SGM 08JAN1 795 Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices accomplishments of SAMHSA programs. The burden for the Center for Mental Health Services (CMHS) will be transferred from this data collection to its own separate Office of Management and Budget (OMB) clearance. The 60day Federal Register Notice for National Outcome Measures (NOMS) for Consumers Receiving Mental Health Services was published on Friday, June 9, 2006 (71 FR 33476). The burden for the CSAP gradually reduces due to the fact that this clearance request only pertains to a continuation of data collection for those grantees initially funded prior to FY2006. The new grantees (FY2006 and beyond) are approved under the NOMS for CSAP (OMB No. 0930–0230). CSAT has no revisions to the instrument and the data collection time will remain the same but there is an increase in the number of respondents due to identifying the seven Screening, Brief Intervention, and Referral to Treatment program grantees that provide data uploads. The estimated annual response burden for this effort is provided in the table below: ESTIMATES OF ANNUALIZED HOUR BURDEN 1 Center/form/respondent type Number of respondents Responses per respondent Total responses Hours per response Total hour burden Added burden proportion 2 Total annual burden hours CSAP GPRA Participant Outcome Measures for Discretionary Programs Participants: FY2007 ..................... FY2008 ..................... 7,000 3,000 3 3 21,000 9,000 .33 .33 6,930 2,970 .72 .72 4,990 2,138 CSAP Subtotal 10,000 3 30,000 .33 9,900 .72 7,128 CSAP Annualized Subtotal ............. 5,000 15,000 3,564 CSAT GPRA Client Outcome Measures for Discretionary Programs Clients .......................... Adults ........................... Adolescents .................. Screening, Brief Intervention and Referral to Treatment (SBIRT): 3 Screening Only ......... Brief Intervention ...... Brief Tx & Referral to Tx .......................... 28,000 3,900 3 4 84,000 15,600 .33 .33 27,720 5,148 .33 .33 9,148 1,699 150,618 27,679 1 3 150,618 83,037 .10 .16 15,062 13,286 0 0 0 0 9,200 3 27,600 .33 9,108 .33 3,006 SBIRT Client Subtotal ...... 187,497 261,255 Client Subtotal ...... 219,397 360,855 Data Extract by Grants: 4 Adult Records ........... Adolescent Records Screening, Brief Intervention and Referral to Tx (SBIRT) Records: Screening Only ......... Brief Intervention ...... Brief Tx & Referral to Tx .......................... 37,456 3,006 13,853 400 grants 73 grants 70 × 3 53 × 4 210 212 .16 .16 34 34 34 34 7 grants 7 grants 21,517 × 1 3,954 × 3 21,517 11,862 .05 .08 1,076 949 1,076 949 7 grants 1,314 × 3 3,942 .16 631 631 480 37,743 Upload 5 ........................ 5 grants 171,639 Upload Subtotal .... 5 grants 171,639 29 CSAT Subtotal ...... jlentini on PROD1PC65 with NOTICES Data Extract Subtotal .................... 219,896 570,237 16,606 TOTAL ........... 224,896 585,237 20,170 2,724 1 hr. per 6,000 records 29 29 NOTES: 1. This table represents the maximum additional burden if adult respondents provide three sets of responses/data and if CSAT adolescent respondents provide four sets of responses/data. 2. Added burden proportion is an adjustment reflecting customary and usual business practices programs engage in (e.g., they already collect the data items). VerDate Aug<31>2005 17:57 Jan 05, 2007 Jkt 211001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM 08JAN1 796 Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices 3. Screening, Brief Intervention, Treatment and Referral (SBIRT) grant program: • 150,618 Screening Only (SO) respondents complete section A of the GPRA instrument, all of these items are asked during a customary and usual intake process resulting in zero burden; and • 27,679 Brief Intervention (BI) respondents complete sections A & B of the GPRA instrument, all of these items are asked during a customary and usual intake process resulting in zero burden; and • 9,200 Brief Treatment (BT) & Referral to Treatment (RT) respondents complete all sections of the GPRA instrument. 4. Data Extract by Grants: Grant burden for capturing customary and usual data. 5. Upload: 5 of the 7 SBIRT grants upload data; the other 2 grants conduct direct data entry. 6. Estimate based on $5.15 for program staff and $15 for IT staff. Written comments and recommendations concerning the proposed information collection should be sent by February 5, 2007 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB’s receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202–395– 6974. Dated: December 22, 2006. Elaine Parry, Acting Director, Office of Program Services. [FR Doc. E6–22576 Filed 1–5–07; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND SECURITY Coast Guard DEPARTMENT OF TRANSPORTATION [USCG–2006–24685] Long Range Aids to Navigation (LORAN) Program; Office of Navigation and Spectrum Management Coast Guard, DHS, Office of the Secretary, DOT. ACTION: Notice; request for public comments. jlentini on PROD1PC65 with NOTICES AGENCY: SUMMARY: The Department of Transportation in coordination with the Department of Homeland Security is considering the need to continue to operate or invest in the North American LORAN–C Radionavigation System beyond fiscal year 2007. Future investment decisions might include: Decommissioning the LORAN–C system, maintaining the LORAN–C system as currently configured, or developing a fully deployed Enhanced LORAN (eLORAN) system. Contributing factors to these decisions are (1) whether the Global Positioning System (GPS) and other available back-up systems are adequate for the public’s navigation and timing needs, thus making the LORAN–C system redundant, and (2) whether the eLORAN investments made to date VerDate Aug<31>2005 17:57 Jan 05, 2007 Jkt 211001 provide enhancements that now merit consideration as a complementary capability to GPS, and not merely as a GPS back-up. The Department of Transportation and the Department of Homeland Security seek public input on the various decisions currently under consideration. For more information on LORAN, you may visit http:// www.navcen.uscg.gov. DATES: Comments and related material must reach the Docket Management Facility on or before February 7, 2007. ADDRESSES: You may submit comments identified by Coast Guard docket number USCG–2006–24685 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods: (1) Web Site: http://dms.dot.gov. (2) Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590–0001. (3) Fax: 202–493–2251. (4) Delivery: Room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366– 9329. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call Mr. Greg Wheeler, Department of Transportation, Office of Navigation and Spectrum Policy, 202–366–4894, e-mail Greg.Wheeler@dot.gov or LT Michael Herring, Project Officer, Office of Navigation Systems, Coast Guard, telephone 202–372–1561, e-mail Michael.L.Herring@uscg.mil. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–493–0402. You may obtain a copy of this notice by calling the U.S. Coast Guard Infoline at 1–800–368–5647 or read it on the Internet on the Coast Guard Navigation Center Web site at http:// www.navcen.uscg.gov or at http:// dms.dot.gov. SUPPLEMENTARY INFORMATION: Request for Comments All comments received will be posted, without change, to http://dms.dot.gov PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 and will include any personal information you have provided. Please see DOT’s ‘‘Privacy Act’’ paragraph below. Submitting comments: If you submit a comment, please include your name and address, identify the docket number for this notice (USCG–2006–24685) and give the reason for each comment. You may submit your comments by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES; but please submit your comments by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments received during the comment period. Viewing comments and documents: To view comments, go to http:// dms.dot.gov at any time, click on ‘‘Simple Search,’’ enter the last five digits of the docket number for this notice, and click on ‘‘Search.’’ You may also visit the Docket Management Facility in room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Privacy Act: Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation’s Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477), or you may visit http://dms.dot.gov. Background and Purpose The North American LORAN–C system is a low frequency hyperbolic radionavigation system. It is approved for use in the U.S. Coastal Confluence Zone (CCZ) and as a supplemental air navigation aid. More information about LORAN–C is available at: http:// www.navcen.uscg.gov/loran/ default.htm. E:\FR\FM\08JAN1.SGM 08JAN1

Agencies

[Federal Register Volume 72, Number 4 (Monday, January 8, 2007)]
[Notices]
[Pages 794-796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22576]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under OMB review, in compliance with the Paperwork 
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these 
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
    Proposed Project: GPRA Client Outcomes for the Substance Abuse and 
Mental Health Services Administration (SAMHSA)--(OMB No. 0930-0208)--
Revision.
    The mission of the Substance Abuse and Mental Health Services 
Administration (SAMHSA) is to improve the effectiveness and efficiency 
of substance abuse and mental health treatment and prevention services 
across the United States. All of SAMHSA's activities are designed to 
ultimately reduce the gap in the availability of substance abuse and 
mental health services and to improve their effectiveness and 
efficiency.
    Data are collected from all SAMHSA discretionary services grants 
and contracts where client/participant outcomes are to be assessed at 
three points (for the Center for Substance Abuse Treatment (CSAT): 
Intake, discharge, and post-intake and for the Center for Substance 
Abuse Prevention (CSAP): pre-intervention, post-intervention, and 
follow-up). SAMHSA-funded projects are required to submit these data as 
a contingency of their award. The analysis of the data also will help 
determine whether the goal of reducing health and social costs of drug 
use to the public is being achieved.
    The primary purpose of this data collection activity is to meet the 
reporting requirements of the Government Performance and Results Act 
(GPRA) by allowing SAMHSA to quantify the effects and

[[Page 795]]

accomplishments of SAMHSA programs.
    The burden for the Center for Mental Health Services (CMHS) will be 
transferred from this data collection to its own separate Office of 
Management and Budget (OMB) clearance. The 60-day Federal Register 
Notice for National Outcome Measures (NOMS) for Consumers Receiving 
Mental Health Services was published on Friday, June 9, 2006 (71 FR 
33476).
    The burden for the CSAP gradually reduces due to the fact that this 
clearance request only pertains to a continuation of data collection 
for those grantees initially funded prior to FY2006. The new grantees 
(FY2006 and beyond) are approved under the NOMS for CSAP (OMB No. 0930-
0230).
    CSAT has no revisions to the instrument and the data collection 
time will remain the same but there is an increase in the number of 
respondents due to identifying the seven Screening, Brief Intervention, 
and Referral to Treatment program grantees that provide data uploads. 
The estimated annual response burden for this effort is provided in the 
table below:

                                                         Estimates of Annualized Hour Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Number of     Responses per       Total         Hours per      Total hour     Added burden    Total annual
       Center/form/respondent type          respondents     respondent       responses       response         burden      proportion \2\   burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            CSAP GPRA Participant Outcome Measures for Discretionary Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants:
  FY2007................................           7,000               3          21,000             .33           6,930             .72           4,990
  FY2008................................           3,000               3           9,000             .33           2,970             .72           2,138
                                         ---------------------------------------------------------------------------------------------------------------
        CSAP Subtotal...................          10,000               3          30,000             .33           9,900             .72           7,128
                                         ---------------------------------------------------------------------------------------------------------------
    CSAP Annualized Subtotal............           5,000  ..............          15,000  ..............  ..............  ..............           3,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              CSAT GPRA Client Outcome Measures for Discretionary Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clients.................................  ..............  ..............  ..............  ..............  ..............  ..............  ..............
Adults..................................          28,000               3          84,000             .33          27,720             .33           9,148
Adolescents.............................           3,900               4          15,600             .33           5,148             .33           1,699
Screening, Brief Intervention and
 Referral to Treatment (SBIRT): \3\
  Screening Only........................         150,618               1         150,618             .10          15,062               0               0
  Brief Intervention....................          27,679               3          83,037             .16          13,286               0               0
  Brief Tx & Referral to Tx.............           9,200               3          27,600             .33           9,108             .33           3,006
                                         ---------------------------------------------------------------------------------------------------------------
        SBIRT Client Subtotal...........         187,497  ..............         261,255  ..............          37,456  ..............           3,006
                                         ---------------------------------------------------------------------------------------------------------------
    Client Subtotal.....................         219,397  ..............         360,855  ..............  ..............  ..............          13,853
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Extract by Grants: \4\
  Adult Records.........................      400 grants          70 x 3             210             .16              34  ..............              34
  Adolescent Records....................       73 grants          53 x 4             212             .16              34  ..............              34
Screening, Brief Intervention and
 Referral to Tx (SBIRT) Records:
  Screening Only........................        7 grants      21,517 x 1          21,517             .05           1,076  ..............           1,076
  Brief Intervention....................        7 grants       3,954 x 3          11,862             .08             949  ..............             949
  Brief Tx & Referral to Tx.............        7 grants       1,314 x 3           3,942             .16             631  ..............             631
                                         ---------------------------------------------------------------------------------------------------------------
    Data Extract Subtotal...............             480  ..............          37,743  ..............  ..............  ..............           2,724
--------------------------------------------------------------------------------------------------------------------------------------------------------
Upload \5\..............................        5 grants  ..............         171,639       1 hr. per              29  ..............              29
                                                                                           6,000 records
                                         ---------------------------------------------------------------------------------------------------------------
    Upload Subtotal.....................        5 grants  ..............         171,639  ..............  ..............  ..............              29
                                         ---------------------------------------------------------------------------------------------------------------
    CSAT Subtotal.......................         219,896  ..............         570,237  ..............  ..............  ..............          16,606
                                         ---------------------------------------------------------------------------------------------------------------
        TOTAL...........................         224,896  ..............         585,237  ..............  ..............  ..............         20,170
--------------------------------------------------------------------------------------------------------------------------------------------------------
NOTES:
1. This table represents the maximum additional burden if adult respondents provide three sets of responses/data and if CSAT adolescent respondents
  provide four sets of responses/data.
2. Added burden proportion is an adjustment reflecting customary and usual business practices programs engage in (e.g., they already collect the data
  items).

[[Page 796]]

 
3. Screening, Brief Intervention, Treatment and Referral (SBIRT) grant program:
 150,618 Screening Only (SO) respondents complete section A of the GPRA instrument, all of these items are asked during a customary and usual
  intake process resulting in zero burden; and
 27,679 Brief Intervention (BI) respondents complete sections A & B of the GPRA instrument, all of these items are asked during a customary and
  usual intake process resulting in zero burden; and
 9,200 Brief Treatment (BT) & Referral to Treatment (RT) respondents complete all sections of the GPRA instrument.
4. Data Extract by Grants: Grant burden for capturing customary and usual data.
5. Upload: 5 of the 7 SBIRT grants upload data; the other 2 grants conduct direct data entry.
6. Estimate based on $5.15 for program staff and $15 for IT staff.

    Written comments and recommendations concerning the proposed 
information collection should be sent by February 5, 2007 to: SAMHSA 
Desk Officer, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, DC 
20503; due to potential delays in OMB's receipt and processing of mail 
sent through the U.S. Postal Service, respondents are encouraged to 
submit comments by fax to: 202-395-6974.

    Dated: December 22, 2006.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E6-22576 Filed 1-5-07; 8:45 am]
BILLING CODE 4162-20-P