Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices 50977 

Requests for Inspection Under the 

Inspection by Accredited Persons 

Program--21 U.S.C. 374(g) (OMB 

Control Number 0910–0569)—Extension 

Section 201 of the Medical Device 

User Fee and Modernization Act of 

2002, (Public Law 107–250), amended 

section 704 of the Federal Food, Drug, 

and Cosmetic Act by adding subsection 

(g) (21 U.S.C. 374 (g)). This amendment 

authorized FDA to establish a voluntary 

third party inspection program 

applicable to manufacturers of class II or 

class III medical devices who meet 

certain eligibility criteria. On September 

15, 2005, FDA issued a guidance 

entitled, ‘‘Requests for Inspection by an 

Accredited Person Under the Inspection 

by Accredited Persons Program 

Authorized by Section 201 of the 

Medical Device User Fee and 

Modernization Act 2002,’’ http:// 

www.fda.gov/cdrh/comp/guidance/ 

1532.html. This guidance describes the 

eligibility criteria and the process for 

establishments to follow when 

requesting FDA’s approval to have an 

accredited person (AP), conduct a 

quality system regulation inspection of 

their establishment under the new 

inspection by the Accredited Persons 

Program (AP program), instead of FDA. 

The AP program applies to 

manufacturers who currently market 

their medical devices in the United 

States and who also market or plan to 

market their devices in foreign 

countries. Such manufacturers may 

need current inspections of their 

establishments to operate in global 

commerce. 

In order to meet the eligibility criteria 

for requesting FDA approval to have an 

AP conduct a quality system regulations 

inspection of their establishment 

instead of FDA, applicants must submit 

a request with certain information. The 

following information must be 

submitted which shows that the 

applicant: 

(1) ‘‘Manufactures, prepares, 

propagates, compounds, or processes’’

class II or class III medical devices, 

(2) Markets at least one of the devices 

in the United States, 

(3) Markets or intends to market at 

least one of the devices in one or more 

foreign countries when one or both of 

the following two conditions are met: 

(a) One of the foreign countries 

certifies, accredits, or otherwise 

recognizes the selected AP applicant as 

a person authorized to conduct 

inspections of device establishments, or 

(b) A statement that the law of a 

country where the applicant markets or 

intends to market the device recognizes 

an inspection conducted by the FDA or 

an AP. 

(4) Provided the most recent 

inspection performed by FDA, or by an 

AP under the AP program and 

inspection was classified by FDA as 

either ‘‘No Action Indicated’’ or 

‘‘Voluntary Action Indicated, ‘‘and, 

(5) Provided notice advising FDA of 

their intent to use an AP, and 

identifying the AP applicant selected. 

In the Federal Register of June 3, 2008 

(73 FR 31692), FDA published a 60-day 

notice requesting public comment on 

the information collection provisions. 

No comments were received. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 U.S.C. Section No. of Respondents Annual Frequency per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

374(g) 100 1 100 15 1,500 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

There are approximately 8,000 foreign 

and 10,000 domestic manufacturers of 

medical devices. Approximately 5,000 

of these firms only manufacture class I 

devices and are, therefore, not eligible 

for the AP program. In addition, 40 

percent of the domestic firms do not 

export devices and therefore are not 

eligible to participate in the AP 

program. Further, 10 to 15 percent of the 

firms are not eligible due to the results 

of their previous inspection. FDA 

estimates there are 4,000 domestic 

manufacturers and 4,000 foreign 

manufacturers that are eligible for 

inclusion under the AP program. Based 

on communications with industry, FDA 

estimates that on an annual basis 

approximately 100 of these 

manufacturers may submit a request to 

use an AP in any given year. 

Dated: August 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20113 Filed 8–28–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Category A and B 

Pathogens. 

Date: September 18, 2008. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817, 

(Telephone Conference Call). 

Contact Person: Lucy A. Ward, DVM, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramual Activities, 

NIAID/NIH/DHHS, 6700B Rockledge Drive, 

MSC 7616, Bethesda, MD 20892, 301–594–

6635, lward@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: August 21, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–19916 Filed 8–28–08; 8:45 am] 

BILLING CODE 4140–01–M 

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