[Federal Register Volume 66, Number 86 (Thursday, May 3, 2001)]
[Notices]
[Pages 22241-22242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11231]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0202]


Medical Devices: Draft ``The Least Burdensome Provisions of the 
FDA Modernization Act of 1997: Concept and Principles;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``The Least Burdensome 
Provisions of the FDA Modernization Act of 1997: Concept and 
Principles.'' In this draft guidance, FDA sets forth its interpretation 
of the provisions of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) that require FDA to take into account the least 
burdensome means for applicants to demonstrate a device's effectiveness 
or substantial equivalence. This guidance is neither final nor is it in 
effect at this time.

DATES: Submit written comments on this draft guidance by August 1, 
2001.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance document entitled ``The Least Burdensome 
Provisions of the FDA Modernization Act of 1997: Concept and 
Principles'' to the Division of Small Manufacturers Assistance (HFZ-
220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818. Submit written comments 
on this draft guidance to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Comments should be identified with the docket number found in 
brackets in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: Joanne R. Less, Center for Devices and 
Radiological Health (HFZ-403), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION:

I. Background

    A central purpose of FDAMA was to ensure the timely availability of 
safe and effective new products that would benefit the American public. 
While Congress wanted to reduce unnecessary burdens associated with the 
premarket clearance and approval processes, Congress did not intend to 
lower the statutory thresholds for substantial equivalence or 
reasonable assurance of safety and effectiveness. To help achieve this 
goal, Congress added section 513(a)(3)(D)(ii) and (i)(1)(D) to the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c).
    These two paragraphs (a)(3)(D)(ii) and (i)(1)(D) of section 513 of 
the law contain what are commonly referred to as the ``least burdensome 
provisions'' of the act. During the last year, FDA has been working 
with the Least Burdensome Industry Task Force to develop an 
interpretation of the least burdensome provisions that would accurately 
capture Congress' intent and that could be implemented consistently by 
FDA and industry. This draft guidance, in addition to the other 
guidances developed by the agency, is a part of that process. As 
presented in this draft guidance, FDA has chosen to apply the least 
burdensome concept beyond the two statutory provisions in which the 
language actually appears. FDA considers the least burdensome concept 
to be one that could affect almost all premarket regulatory activities, 
including presubmission meetings with industry, premarket submissions, 
and the development of guidance documents and regulations.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on the least burdensome provisions of the act. 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 applicable statutes and regulations.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115; 65 FR 56468, September 19, 2000). This draft guidance document 
is issued as a Level 1 guidance in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``The Least Burdensome Provisions of the FDA 
Modernization Act of 1997: Concept and Principles'' via your fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone. Press 1 to enter

[[Page 22242]]

the system. At the second voice prompt press 1 to order a document. 
Enter the document number (1332) followed by the pound sign (#). Follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. Guidance documents are also available on the Dockets Management 
Branch Web site at http://www.fda.gov/ohrms/ dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by 
August 1, 2001. Submit two copies of any comments, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance document and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 30, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-11231 Filed 5-1-01; 12:40 pm]
BILLING CODE 4160-01-S