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46638 Federal Register / Vol. 72, No.

161 / Tuesday, August 21, 2007 / Notices

Dated: August 15, 2007. of registration with appropriate fees. classification; (2) establishment
Jeffrey Shuren, Seats are very limited; please submit registration; (3) device listing; (4)
Assistant Commissioner for Policy. registration as soon as possible. Those premarket notification; (5) premarket
[FR Doc. E7–16470 Filed 8–20–07; 8:45 am] accepted into the course will receive approval; (6) quality system regulation;
confirmation. Registration will close (7) labeling; (8) recalls, removals, and
after the course is filled. Registration at corrections; (9) medical device
the site may be available based on space reporting; (10) tracking; and (11)
DEPARTMENT OF HEALTH AND availability on the day of the public postmarket surveillance.
HUMAN SERVICES workshop beginning at 8 a.m. The cost Dated: August 15, 2007.
of registration at the site is $99 payable Jeffrey Shuren,
Food and Drug Administration to FMDIC. The registration fee will be Assistant Commissioner for Policy.
used to offset expenses associated with
Medical Devices 101: An Educational [FR Doc. E7–16375 Filed 8–20–07; 8:45 am]
this event including lunch,
Forum; Public Workshop refreshments, and course materials. BILLING CODE 4160–01–S

AGENCY: Food and Drug Administration, If you require special

HHS. accommodations due to a disability,
please contact David Arvelo (see
ACTION: Notice of public workshop. HUMAN SERVICES
Contact Person) at least 21 days in
SUMMARY: The Food and Drug advance. Health Resources and Services
Administration (FDA), Office of Transcripts: Transcripts of the public Administration
Regulatory Affairs (ORA), Southwest workshop will not be available due to
Regional Office (SWRO), in the format of this workshop. Course Agency Information Collection
cosponsorship with the FDA Medical handouts may be requested in writing Activities: Submission for OMB
Device Industry Coalition (FMDIC), is from the Freedom of Information Office Review; Comment Request
announcing a public workshop entitled (HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm. Periodically, the Health Resources
‘‘Medical Devices 101: An Educational and Services Administration (HRSA)
Forum.’’ This public workshop, 6–30, Rockville, MD 20857,
approximately 15 working days after the publishes abstracts of information
presented previously on February 9, collection requests under review by the
2007, is intended to provide an public workshop at an estimated cost of
10 cents per page. Office of Management and Budget, in
overview on FDA’s medical device compliance with the Paperwork
requirements to entrepreneurs, startup SUPPLEMENTARY INFORMATION: The Reduction Act of 1995 (44 U.S.C. 3501
companies, and small businesses. workshop, previously presented on et seq.). To request a copy of the
Date and Time: The public workshop February 9, 2007 (72 FR 968, January 9, clearance requests submitted to OMB for
will be held on October 26, 2007, from 2007), is being held in response to the review, call the HRSA Reports
8 a.m. to 5 p.m. interest in the topics discussed from Clearance Office on (301) 443–1129.
Location: The public workshop will small medical device entrepreneurs and The following request has been
be held at the FDA SWRO, 4040 North startup manufacturers in the Dallas submitted to the Office of Management
Central Expressway, 9th floor District area. FDA presents this and Budget for review under the
conference room, Dallas, TX. workshop in cosponsorship with FMDIC Paperwork Reduction Act of 1995:
Contact Person: David Arvelo, Food to help achieve objectives set forth in
and Drug Administration, 4040 North section 406 of the Food and Drug Proposed Project: Data Collection Tool
Central Expressway, suite 900, Dallas, Administration Modernization Act of for the Black Lung Clinics Program:
TX 75204, 214–253–4952, FAX: 214– 1997 (21 U.S.C. 393), which include (OMB No. 0915–0292) Revision
253–4970, e-mail: working closely with stakeholders and The Office of Rural Health Policy
oraswrsbr@fda.hhs.gov. maximizing the availability and clarity (ORHP), Health Resources and Services
Registration: FMDIC has a $75 early of information to stakeholders and the Administration, conducts an annual
registration fee. The early registration public. This is also consistent with the data collection of user information for
fee for government officials is $50 and purposes of FDA’s Regional Small the Black Lung Clinics Program. The
for students is $25 with positive Business Program, which are in part to purpose of the Black Lung Clinics
identification. Early registration ends respond to industry inquiries, develop Program is to improve the health status
October 12, 2007. After October 12, educational materials, and sponsor of coal workers by providing services to
2007, registration is $100 for the public workshops and conferences to provide minimize the effects of respiratory and
at large, $75 for government officials, firms, particularly small businesses, pulmonary impairments of coal miners.
and $50 for students with positive with firsthand working knowledge of Grantees provide specific diagnostic and
identification. To register online, please FDA’s requirements and compliance treatment procedures required in the
visit http://www.fmdic.org/. As an policies. This workshop is also management of problems associated
alternative, you may mail your consistent with the Small Business with black lung disease which improves
registration information including Regulatory Enforcement Fairness Act of the quality of life of the miner and
name, title, organization or company 1996 (Public Law 104–121), as an reduces economic costs associated with
name, physical address, telephone and outreach activity by Government morbidity and mortality arising from
fax numbers, and e-mail address, along agencies to small businesses. pulmonary diseases. The purpose of
with a check or money order for the The goal of the workshop is to present collecting this data is to provide HRSA
appropriate amount payable to the information that will enable with information on how well each
rmajette on PROD1PC64 with NOTICES

FMDIC, to William Hyman, Texas A&M manufacturers and regulated industry to grantee is meeting the needs of active
University, Department of Biomedical better comply with the Medical Device and retired miners in the funded
Engineering, 3120 TAMU, College Quality System Regulation. The communities.
Station, TX 75843–3120. The available following topics will be broadly covered Data from the annual report will
space will be filled in order of receipt at the workshop: (1) Medical device provide quantitative information about

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