Agency Information Collection Activities: Submission for OMB Review; Comment Request, 46638-46639 [E7-16368]

Download as PDF 46638 Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Notices Dated: August 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–16470 Filed 8–20–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Devices 101: An Educational Forum; Public Workshop AGENCY: Food and Drug Administration, HHS. rmajette on PROD1PC64 with NOTICES ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ‘‘Medical Devices 101: An Educational Forum.’’ This public workshop, presented previously on February 9, 2007, is intended to provide an overview on FDA’s medical device requirements to entrepreneurs, startup companies, and small businesses. Date and Time: The public workshop will be held on October 26, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the FDA SWRO, 4040 North Central Expressway, 9th floor conference room, Dallas, TX. Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214–253–4952, FAX: 214– 253–4970, e-mail: oraswrsbr@fda.hhs.gov. Registration: FMDIC has a $75 early registration fee. The early registration fee for government officials is $50 and for students is $25 with positive identification. Early registration ends October 12, 2007. After October 12, 2007, registration is $100 for the public at large, $75 for government officials, and $50 for students with positive identification. To register online, please visit http://www.fmdic.org/. As an alternative, you may mail your registration information including name, title, organization or company name, physical address, telephone and fax numbers, and e-mail address, along with a check or money order for the appropriate amount payable to the FMDIC, to William Hyman, Texas A&M University, Department of Biomedical Engineering, 3120 TAMU, College Station, TX 75843–3120. The available space will be filled in order of receipt VerDate Aug<31>2005 15:08 Aug 20, 2007 Jkt 211001 of registration with appropriate fees. Seats are very limited; please submit registration as soon as possible. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site may be available based on space availability on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $99 payable to FMDIC. The registration fee will be used to offset expenses associated with this event including lunch, refreshments, and course materials. If you require special accommodations due to a disability, please contact David Arvelo (see Contact Person) at least 21 days in advance. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857, approximately 15 working days after the public workshop at an estimated cost of 10 cents per page. SUPPLEMENTARY INFORMATION: The workshop, previously presented on February 9, 2007 (72 FR 968, January 9, 2007), is being held in response to the interest in the topics discussed from small medical device entrepreneurs and startup manufacturers in the Dallas District area. FDA presents this workshop in cosponsorship with FMDIC to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is also consistent with the purposes of FDA’s Regional Small Business Program, which are in part to respond to industry inquiries, develop educational materials, and sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA’s requirements and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121), as an outreach activity by Government agencies to small businesses. The goal of the workshop is to present information that will enable manufacturers and regulated industry to better comply with the Medical Device Quality System Regulation. The following topics will be broadly covered at the workshop: (1) Medical device PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 classification; (2) establishment registration; (3) device listing; (4) premarket notification; (5) premarket approval; (6) quality system regulation; (7) labeling; (8) recalls, removals, and corrections; (9) medical device reporting; (10) tracking; and (11) postmarket surveillance. Dated: August 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–16375 Filed 8–20–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget, in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Data Collection Tool for the Black Lung Clinics Program: (OMB No. 0915–0292) Revision The Office of Rural Health Policy (ORHP), Health Resources and Services Administration, conducts an annual data collection of user information for the Black Lung Clinics Program. The purpose of the Black Lung Clinics Program is to improve the health status of coal workers by providing services to minimize the effects of respiratory and pulmonary impairments of coal miners. Grantees provide specific diagnostic and treatment procedures required in the management of problems associated with black lung disease which improves the quality of life of the miner and reduces economic costs associated with morbidity and mortality arising from pulmonary diseases. The purpose of collecting this data is to provide HRSA with information on how well each grantee is meeting the needs of active and retired miners in the funded communities. Data from the annual report will provide quantitative information about E:\FR\FM\21AUN1.SGM 21AUN1 46639 Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Notices the programs, specifically: (a) The characteristics of the patients they serve (gender, age, disability level, occupation type); (b) the characteristics of services provided (medical, non-medical, or counseling); (c) number of patients served and visits conducted (encounters); and (d) the improvement in pulmonary function of patients (pulmonary rehabilitation). This assessment will provide data useful to the program and will enable HRSA to provide data required by Congress under the Government Performance and Results Act of 1993. It will also ensure that the organizations funded have demonstrated a need for services in their communities and that funds are being effectively used to provide services to meet those needs. The estimated burden is as follows: Form name Number of respondents Hours per response Total burden hours Database ...................................................................................................................................... 15 20 300 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: August 15, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–16368 Filed 8–20–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Health Resources and Services Administration, HHS. ACTION: Correction of total burden hours. AGENCY: SUMMARY: The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of July 31, 2007 (FR Doc. E7–14680), on page 41759, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915–0193). In the burden table, the total burden hours published are incorrect. Correction In the Federal Register issue of July 31, 2007, FR Doc. E7–14680), on page 41759, correct the Total Burden Hours as follows: The purpose of these surveys is to conduct a follow-up study to the National Practitioner Data Bank (NPDB) Total ............................... 60,804 User and Non-User Surveys of 2001. In addition, Healthcare Integrity and Protection Data Bank (HIPDB) users and Dated: August 15, 2007. non-sers will be included in this study. Alexandra Huttinger, The study will evaluate the Acting Director, Division of Policy Review effectiveness of the NPDB and the and Coordination. HIPDB as flagging systems, sources of [FR Doc. E7–16370 Filed 8–20–07; 8:45 am] information, and decisionmaking tools. BILLING CODE 4165–15–P It will also determine user satisfaction with the process, use, and information provided by the NPDB and HIPDB. DEPARTMENT OF HEALTH AND Surveys will be administered to HUMAN SERVICES entities that report to and/or query the NPDB and HIPDB, including users who Health Resources and Services query either the NPDB and/or HIPDB Administration and who receive a ‘‘match’’, i.e. copies of adverse actions concerning a queried Agency Information Collection practitioner. A sample of Queriers who Activities: Submission for OMB received a matched response will be Review; Comment Request surveyed about the information received. NPDB and HIPDB non-users Periodically, the Health Resources will also be surveyed. Eligible NPDB and Services Administration (HRSA) and HIPDB users will be asked to publishes abstracts of information complete a Web-based Internet survey collection requests under review by the or a computer-assisted telephone Office of Management and Budget interview (CATI). NPDB and HIPDB (OMB), in compliance with the non-users will complete either a Web or Paperwork Reduction Act of 1995 (44 CATI, or will be transferred to an U.S.C. Chapter 35). To request a copy of interactive voice response (IVR) system the clearance requests submitted to during the CATI to complete the survey. Data gathered from the survey will be OMB for review, call the HRSA Reports compared with similar information from Clearance Office on (301) 443–1129. previous surveys of users and non-users The following request has been and will provide HRSA with the submitted to the Office of Management information necessary to improve the and Budget for review under the usability of the NPDB and HIPDB. Paperwork Reduction Act of 1995: The estimate of burden is as follows: Universal report .................... Grant report .......................... rmajette on PROD1PC64 with NOTICES Respondents Respondent description NPDB Users Group Survey 15:08 Aug 20, 2007 Jkt 211001 PO 00000 Frm 00041 58,104 2,700 Responses per respondent Number of respondents Malpractice Payers ............ Licensing Boards ............... Hospitals (Reporting) ......... Hospitals (Querying) .......... MCOs ................................ VerDate Aug<31>2005 Total burden hours Type of report Proposed Project: National Practitioner Data Bank and Healthcare Integrity and Protection Data Bank Market Surveys and Survey of Use of Data Bank Information by Queriers: NEW 228 90 466 994 900 Fmt 4703 Sfmt 4703 Total responses 1 1 1 1 1 E:\FR\FM\21AUN1.SGM 228 90 466 994 900 21AUN1 Hours per response Total burden (hours) .25 .25 .25 .25 .25 57 22.5 116.5 248.5 225

Agencies

[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Notices]
[Pages 46638-46639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


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

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget, in compliance with the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). To request a 
copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office on (301) 443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Data Collection Tool for the Black Lung Clinics 
Program: (OMB No. 0915-0292) Revision

    The Office of Rural Health Policy (ORHP), Health Resources and 
Services Administration, conducts an annual data collection of user 
information for the Black Lung Clinics Program. The purpose of the 
Black Lung Clinics Program is to improve the health status of coal 
workers by providing services to minimize the effects of respiratory 
and pulmonary impairments of coal miners. Grantees provide specific 
diagnostic and treatment procedures required in the management of 
problems associated with black lung disease which improves the quality 
of life of the miner and reduces economic costs associated with 
morbidity and mortality arising from pulmonary diseases. The purpose of 
collecting this data is to provide HRSA with information on how well 
each grantee is meeting the needs of active and retired miners in the 
funded communities.
    Data from the annual report will provide quantitative information 
about

[[Page 46639]]

the programs, specifically: (a) The characteristics of the patients 
they serve (gender, age, disability level, occupation type); (b) the 
characteristics of services provided (medical, non-medical, or 
counseling); (c) number of patients served and visits conducted 
(encounters); and (d) the improvement in pulmonary function of patients 
(pulmonary rehabilitation). This assessment will provide data useful to 
the program and will enable HRSA to provide data required by Congress 
under the Government Performance and Results Act of 1993. It will also 
ensure that the organizations funded have demonstrated a need for 
services in their communities and that funds are being effectively used 
to provide services to meet those needs.
    The estimated burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                                  Number of        Hours per       Total burden
                          Form name                              respondents        response          hours
----------------------------------------------------------------------------------------------------------------
Database.....................................................              15               20              300
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by e-mail to OIRA_
submission@omb.eop.gov or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: August 15, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
 [FR Doc. E7-16368 Filed 8-20-07; 8:45 am]
BILLING CODE 4165-15-P