[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Rules and Regulations]
[Pages 3584-3586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1404]


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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 Material Citations

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Direct final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending certain 
references in various medical device regulations. The amendments update 
the references in those regulations to various standards of the 
American Society for Testing and Materials (ASTM) to reflect the 
current standards designations. Elsewhere in this issue of the Federal 
Register, FDA is publishing a companion proposed rule, under FDA's 
usual procedures for notice-and-comment, to provide a procedural 
framework to finalize the rule in the event that the agency receives 
any significant adverse comment and withdraws the direct final rule.

DATES:  The rule is effective June 7, 2000. Submit written comments on 
or before

[[Page 3585]]

April 10, 2000. If FDA receives no significant adverse comments within 
the specified comment period, the agency intends to publish in the 
Federal Register a document confirming the effective date of the direct 
final rule within 30 days after the comment period on this direct final 
rule ends. If the agency receives any adverse comments, FDA intends to 
withdraw this final rule by publication in the Federal Register of a 
document within 30 days after the comment period ends. The Director of 
the Office of the Federal Register approves the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of 
certain publications in Sec. 801.410(d)(2) (21 CFR 801.410(d)(2)) and 
Sec. 801.430(f)(2) (21 CFR 801.430(f)(2), effective June 7, 2000.

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 
revising the device regulations identified by ASTM that contain 
obsolete or withdrawn ASTM standards to reflect the current ASTM 
standards designations. FDA will update the citations for the food 
additive regulations in a separate rulemaking.
    This direct final rule amends Secs. 801.410(d)(2) and 801.430(f)(2) 
by incorporating by reference into the regulation the updated standard 
as follows:
     Section 801.410 Use of impact-resistant lenses in 
eyeglasses and sunglasses--The agency is amending 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,''.
     Section 801.430 User labeling for menstrual tampons--The 
agency is amending 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 and Materials.

II. Additional Information

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
described when and how it will employ direct final rulemaking. FDA 
believes this rule is appropriate for direct final rulemaking because 
FDA views this rule as making noncontroversial amendments to existing 
regulations, i.e., adopting revised ASTM methods for certain medical 
device regulations, and FDA anticipates no significant adverse 
comments. Consistent with FDA's procedures on direct final rulemaking, 
elsewhere in this issue of the Federal Register, FDA is publishing a 
companion proposed rule to amend the relevant medical device 
regulations. The companion proposed rule is substantially identical to 
the direct final rule. The companion proposed rule provides a 
procedural framework within which the rule may be finalized in the 
event the direct final rule is withdrawn because of any significant 
adverse comments. The comment period for the direct final rule runs 
concurrently with the comment period of the companion proposed rule. 
Any comments received under the companion proposed rule will be 
considered as comments regarding the direct final rule.
    FDA is providing a comment period on the direct final rule of 75 
days after January 24, 2000. If the agency receives any significant 
adverse comments, FDA intends to withdraw this final rule by 
publication in the Federal Register of a document within 30 days after 
the comment period ends. 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. 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.
    If FDA withdraws the direct final rule, all comments received will 
be considered under the companion proposed rule in developing a final 
rule under the usual notice-and-comment procedures under the 
Administrative Procedure Act (5 U.S.C. 552 et seq.). If FDA receives no 
significant adverse comments during the specified comment period, FDA 
intends to publish a confirmation notice in the Federal Register within 
30 days after the comment period ends. FDA intends to make the direct 
final rule effective June 7, 2000.

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 final 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

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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 significant adverse impact on those who 
use the standard. Thus, the rule is not a significant regulatory action 
as defined in Executive Order 12866, and so is not subject to review 
under the Executive Order.
    Under section 603(a) of the Regulatory Flexibility Act (RFA), for 
any proposed rule for which the agency is required by section 553 of 
the Administrative Procedure Act or any other law to publish a general 
notice of proposed rulemaking, the agency is required to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. The agency has published, in the companion 
proposed rule published elsewhere in this Federal Register, an initial 
regulatory flexibility analysis. Because the companion proposed rule is 
a proposed rule for which a general notice of proposed rulemaking is 
required, and therefore is subject to the RFA, the agency will consider 
any comments it receives on the initial regulatory flexibility analysis 
in the companion proposed rule when deciding whether to withdraw this 
direct final rule.

V. Paperwork Reduction Act of 1995

    This direct final 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 final rule. The comment period runs concurrently with the comment 
period for the companion proposed rule. 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. All comments 
received will be considered as comments regarding the proposed rule and 
this direct final rule. In the event that the direct final rule is 
withdrawn, all comments received regarding the companion proposed rule 
and the direct final rule will be considered as comments on the 
proposed rule.

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 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 and 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. 00-1404 Filed 1-21-00; 8:45 am]
BILLING CODE 4160-01-F