[Federal Register: November 10, 2004 (Volume 69, Number 217)]
[Page 65201-65202]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0332]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Third-Party Review Under the Food and Drug Administration Modernization 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 10, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Devices; Third-Party Review Under the Food and Drug 
Administration Modernization Act--(OMB Control Number 0910-0375)--

    Section 210 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) established section 523 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit 
persons in the private sector to review certain premarket applications 
and notifications. Participation in this third-party review program by 
accredited persons is entirely voluntary. A third party wishing to 
participate will submit a request for accreditation to FDA. Accredited 
third-party reviewers have the ability to review a manufacturer's 
510(k) submission for selected devices. After reviewing a submission, 
the reviewer will forward a copy of the 510(k) submission, along with 
the reviewer's documented review and recommendation to FDA. Third-party 
reviews should maintain records of their 510(k) reviews and a copy of 
the 510(k) for a reasonable period of time, usually a period of 3 
years. This information collection will allow FDA to continue to 
implement the accredited person review program established by FDAMA and 
improve the efficiency of 510(k) review for low to moderate risk 
    Respondents to this information collection are businesses or other 
for-profit organizations.
    In the Federal Register of August 10, 2004 (69 FR 48508), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                      Annual Frequency per                                 Hours per
             21 CFR Section                 No. of Recordkeepers             Record             Total Annual Records      Recordkeeper     Total Hours
Requests for accreditation                                     15                         1                        15               24              360
510(k) reviews conducted by accredited                         15                        14                       210               40            8,400
 third parties
Totals                                    ........................  ........................  ........................  ...............           8,760
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 65202]]

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
                                                                                 Annual Frequency      Total Annual        Hours per
                   21 CFR Section                       No. of Recordkeepers        per Record            Records         Recordkeeper     Total Hours
510(k) reviews                                                             15                  14                 210               10            2,100
Totals                                                ........................  ..................  ..................  ...............           2,100
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burdens are explained as follows:

I. Reporting

A. Requests for Accreditation

    Under the agency's third-party review pilot program, the agency 
received 37 applications for recognition as third-party reviewers, of 
which the agency recognized 7. In the past 3 years, the agency has 
averaged receipt of 15 applications for recognition of third-party 
review accredited persons. The agency has accredited 15 of the 
applicants to conduct third-party reviews.

B. 510(k) Reviews Conducted by Accredited Third Parties

    In the 18 months under the third-party review pilot program, FDA 
received 22 submissions of 510(k)s that requested and were eligible for 
review by third parties. The agency has experienced that the number of 
510(k)s submitted annually for third-party review since the last OMB 
approval in 2001 is approximately 210 annually, which is 14 annual 
reviews per each of the estimated 15 accredited reviewers.

II. Recordkeeping

    Third-party reviewers are required to keep records of their review 
of each submission. The agency anticipates approximately 140 annual 
submissions of 510(k)s for third-party review.

    Dated: November 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24994 Filed 11-9-04; 8:45 am]