[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Proposed Rules]
[Pages 3627-3629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1405]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 99N-4955]


Amendment of Various Device Regulations to Reflect Current 
American Society for Testing and Materials Citations; Companion 
Document to Direct Final Rule

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is proposing to amend 
certain references in various medical device regulations. The 
amendments would update the references in those regulations to various 
standards of the American Society for Testing and Materials (ASTM) to 
reflect the current standards designations. This proposed rule is a 
companion document to the direct final rule published elsewhere in this 
issue of the Federal Register.

DATES:  Submit written comments by April 10, 2000. If FDA receives no 
significant adverse comment on these various medical devices 
regulations within the specified comment period, the agency intends to 
publish in the Federal Register a document confirming the effective 
date of the final rule within 30 days after the comment period on the 
direct final rule ends. The direct final rule will be effective June 7, 
2000. If FDA receives any significant adverse comment regarding this 
rule, FDA will publish a document withdrawing the direct final rule 
within 30 days after the comment period ends and will proceed to 
respond to all of the comments under this companion proposed rule using 
usual notice-and-comment procedures. The comment period for this 
companion proposed rule runs concurrently with the direct final rule 
comment period.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Philip L. Chao, Office of Policy, 
Planning, and Legislation (HF-23), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3380.

SUPPLEMENTARY INFORMATION:

I. Background

    The ASTM notified FDA that ASTM had been working on a project to 
help Federal agencies update and maintain the ASTM standards that are 
referenced in the Code of Federal Regulations (CFR's). Use of consensus 
standards such as those developed by ASTM is consistent with the 
purposes of the National Technology Transfer and Advancement Act of 
1995, signed into law on March 7, 1996 (Public Law 104-113). As part of 
the ASTM project, ASTM informed FDA that many ASTM standards cited in 
FDA's food additive and device regulations were out-of-date and 
provided a list of standards with their current year designations. ASTM 
listed 58 different regulations which, in its opinion, needed to be 
updated.
    FDA examined the ASTM's documentation and, upon closer examination, 
found that 56 of the 58 different FDA regulations identified by ASTM 
cited obsolete ASTM standards or that, in some cases, cited ASTM 
standards that had been withdrawn. Most regulations involved direct and 
indirect food additives, although two of the affected regulations 
involved medical devices. Consequently, through this rulemaking, FDA is 
proposing to revise the device regulations identified by ASTM that 
contain obsolete or withdrawn ASTM standards to reflect

[[Page 3628]]

the current ASTM standards designations. FDA will update the citations 
for the food additive regulations in a separate rulemaking.
    This rule is proposing to amend Secs. 801.410(d)(2) and 
801.430(f)(2) (21 CFR 801.410(d)(2) and 801.430(f)(2)) by incorporating 
by reference into the regulation the updated standard as follows:
    <bullet> Section 801.410 Use of impact-resistant lenses in 
eyeglasses and sunglasses--The proposal would amend paragraph (d)(2) by 
removing ``ASTM Method D 1415-68 `Test for International Hardness of 
Vulcanized Rubber,' '' and by adding in its place ``ASTM Method D 1415-
88, Standard Test Method for Rubber Property--International Hardness,'' 
and also by removing ``ASTM Method D 412-68 `Tension Test of Vulcanized 
Rubber,' '' and by adding in its place ``ASTM Method D 412-97, Standard 
Test Methods for Vulcanized Rubber and Thermoplastic Rubbers and 
Thermoplastic Elastomers--Tension,''.
    <bullet> Section 801.430 User labeling for menstrual tampons --The 
proposal would amend paragraph (f)(2) by removing ``(ASTM), D 3492-83, 
`Standard Specification for Rubber Contraceptives (Condoms)' '' and by 
adding in its place ``(ASTM) D 3492-96, Standard Specification for 
Rubber Contraceptives (Male Condoms)''.
    In addition, FDA is updating in Sec. 801.410(d)(2) the address for 
the American Society for Testing Materials.

II. Additional Information

    This proposed rule is a companion to the direct final rule 
published in the final rule section of this issue of the Federal 
Register. This companion proposed rule is substantially identical to 
the direct final rule. FDA is publishing the direct final rule because 
the rule contains noncontroversial changes, and FDA anticipates that it 
will receive no significant adverse comments. A detailed discussion of 
this rule is set forth in the preamble of the direct final rule. If no 
significant comment is received in response to the direct final rule, 
no further action will be taken related to this proposed rule. Instead, 
FDA will publish in the Federal Register a confirmation within 30 days 
after the comment period ends confirming that the direct final rule 
will go into effect on June 7, 2000. Additional information about FDA's 
direct final rulemaking procedures is set forth in a guidance published 
in the Federal Register of November 21, 1997 (62 FR 62466).
    If FDA receives any significant adverse comment regarding this 
rule, FDA will publish a document withdrawing the direct final rule 
within 30 days after the comment period ends and will proceed to 
respond to all of the comments under this companion proposed rule using 
usual notice-and-comment procedures. The comment period for this 
companion proposed rule runs concurrently with the direct final rule's 
comment period. Any comments received under this companion proposed 
rule will be considered as comments regarding the direct final rule.
    A significant adverse comment is defined as a comment that explains 
why the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or would be ineffective or unacceptable 
without change. In determining whether a significant adverse comment is 
sufficient to terminate a direct final rulemaking, FDA will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-comment process. Comments that are 
frivolous, insubstantial, or outside the scope of the rule will not be 
considered significant or adverse under this procedure. For example, a 
comment recommending a rule change in addition to the rule will not be 
considered a significant adverse comment unless the comment states why 
the rule would be ineffective without the additional change. In 
addition, if a significant adverse comment applies to an amendment, 
paragraph, or section of this rule and that provision can be severed 
from the remainder of the rule, FDA may adopt as final those provisions 
of the rule that are not the subject of a significant adverse comment.

III. Environmental Impact

    The agency has determined, under 21 CFR 25.30(i) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 12866 
classifies a rule as significant if it meets any one of a number of 
specified conditions, including having an annual effect on the economy 
of $100 million or adversely affecting in a material way a sector of 
the economy, competition, or jobs, or if it raises novel legal or 
policy issues. The revised ASTM standard citations that FDA is adopting 
in the medical device regulations reflect minor changes to the 
currently listed methods in those regulations. The updated citations 
are the result of periodic reapprovals of long-standing test methods or 
standards and should have no impact on those who use the standard. 
Thus, the proposal is not a significant regulatory action as defined in 
Executive Order 12866, and so is not subject to review under the 
Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. The proposed rule, if finalized, would 
simply update ASTM citations used in various device regulations. The 
updated citations are the result of periodic re-approvals of long-
standing ASTM test methods or standards and will have no significant 
adverse impact on those who use the ASTM standards. Under the 
Regulatory Flexibility Act, FDA certifies that the proposed rule will 
not impose any additional regulatory burdens on small entities.

V. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.
    Interested persons may, on or before April 10, 2000, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, 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. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 801

    Hearing aids, Incorporation by reference, Medical devices, 
Professional and patient labeling.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 3629]]

of Food and Drugs, 21 CFR part 801 is amended as follows:

PART 801--LABELING

    1. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.


Sec. 801.410  [Amended]

    2. Section 801.410 Use of impact-resistant lenses in eyeglasses and 
sunglasses is amended in paragraph (d)(2) by removing ``ASTM Method D 
1415-68 `Test for International Hardness of Vulcanized Rubber,' '' and 
by adding in its place ``ASTM Method D 1415-88, Standard Test Method 
for Rubber Property--International Hardness,''; by removing ``ASTM 
Method D 412-68 `Tension Test of Vulcanized Rubber,''' and by adding in 
its place ``ASTM Method D 412-97, Standard Test Methods for Vulcanized 
Rubber and Thermoplastic Rubbers and Thermoplastic Elastomers--
Tension,''; and by removing ``1916 Race St., Philadelphia, PA 19103, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408).'' and by 
adding in its place ``100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428, or available for inspection at the Center for 
Devices and Radiological Health's Library, 9200 Corporate Blvd., 
Rockville, MD 10850, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.''


Sec. 801.430  [Amended]

    3. Section 801.430 User labeling for menstrual tampons is amended 
in paragraph (f)(2) by removing ``(ASTM), D 3492-83, `Standard 
Specification for Rubber Contraceptives (Condoms)' '' and by adding in 
its place ``(ASTM) D 3492-96, `Standard Specification for Rubber 
Contraceptives (Male Condoms)' ''; and by revising the footnote to read 
``Copies of the standard are available from the American Society for 
Testing Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, or 
available for inspection at the Center for Devices and Radiological 
Health's Library, 9200 Corporate Blvd., Rockville, MD 10850, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.''

    Dated: December 29, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-1405 Filed 1-21-00; 8:45 am]
BILLING CODE 4160-01-F