[Federal Register Volume 65, Number 138 (Tuesday, July 18, 2000)]
[Rules and Regulations]
[Pages 44435-44436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18082]


=======================================================================
-----------------------------------------------------------------------

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; Confirmation in 
Part and Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation in part and technical 
amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is confirming, in part, 
the direct final rule 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. In 
addition, FDA is correcting errors made in the direct final rule 
regarding ASTM's address and an FDA zip code.

DATES: The direct final rule published on January 24, 2000 (65 FR 
3627), as amended by this rule, is effective June 7, 2000.

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: In the Federal Register of January 24, 2000 
(65 FR 3627), FDA published a direct final rule and a companion 
proposed rule to amend various medical device regulations. The 
amendments would update references in those regulations to various 
standards issued by the American Society for Testing and Materials 
(ASTM). The preamble to the direct final rule and the companion 
proposed rule explained 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. 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additive and device regulations were out-of-date and provided a list of 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.
    Based on information received from ASTM, FDA, through the direct 
final rule and companion proposed rule, identified several device 
regulations that contained obsolete or withdrawn ASTM standards. The 
medical device regulations and the ASTM standards at issue are:
     21 CFR 801.410 Use of impact-resistant lenses in 
eyeglasses and sunglasses--The agency proposed to amend paragraph 
(d)(2) by replacing ``ASTM Method D 1415-68 `Test for International 
Hardness of Vulcanized Rubber,''' with ``ASTM Method D 1415-88, 
`Standard Test Method for Rubber Property--International Hardness,''' 
and also replace ``ASTM Method D 412-68 `Tension Test of Vulcanized 
Rubber''' with ``ASTM Method D 412-97, `Standard Test Methods for 
Vulcanized Rubber and Thermoplastic Rubbers and Thermoplastic 
Elastomers--Tension'''.
     21 CFR 801.430 User labeling for menstrual tampons--The 
agency sought to amend paragraph (f)(2) by replacing ``(ASTM) D 3492-
83, `Standard Specification for Rubber Contraceptives (Male Condoms)''' 
with ``(ASTM) D 3492-96, `Standard Specification for Rubber 
Contraceptives (Male Condoms)'''.
    FDA received one comment. The comment, submitted by ASTM, pointed 
out that because ASTM had revised two of the cited ASTM references 
again, the two references in the direct final rule were now obsolete. 
ASTM recommended changing D412-97 to D412-98A and D3492-96 to D3492-97 
to reflect the current ASTM cites. ASTM's comment explained how the 
standards had changed and provided detailed descriptions of the changes 
in its comment. In general, the changes were not significant; some 
changes involved removing terms that were not commonly used or defined, 
deleting redundant wording, adding metric measurements, and changing 
measurement methods to improve accuracy or clarity.
    Because these changes are not significant and ASTM has already made 
these changes to its standards, FDA finds for good cause that notice 
and public comment on the latest ASTM standards citation revisions is 
unnecessary.
    Therefore, FDA is confirming, in part, the direct final rule 
insofar as it pertains to Sec. 801.410 and its reference to ASTM Method 
D 1415-88, ``Standard Test Method for Rubber Property--International 
Hardness'' and the addresses where the standards may be found or 
inspected. Similarly, FDA is confirming the addresses in Sec. 801.430 
where the standards may be found or inspected, although it is 
correcting errors that were made in the direct final rule regarding the 
ASTM's address.

[[Page 44436]]

    FDA is amending Sec. 801.410 by replacing ``ASTM Method D 412-97'' 
with ``ASTM Method D 412-98A'' and using the current title for ASTM 
method D 412.98A. FDA is also amending Sec. 801.430(f)(2) by replacing 
``(ASTM), D 3492-96,'' with ``(ASTM) D 3492-97,''.

List of Subjects 21 CFR Part 801

    Hearing aids, Medical devices, Professional and patient labeling.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, the 
direct final rule published on January 24, 2000 (65 FR 3627), is 
confirmed as effective June 7, 2000, with the following changes:

PART 801--LABELING

    1. The authority citation for 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 412-97, Standard Test Methods for Vulcanized Rubber and 
Thermoplastic Rubbers and Thermoplastic Elastomers--Tension,'' and by 
adding in its place ``ASTM Method D 412-98A, `Standard Test Methods for 
Vulcanized Rubber and Thermoplastic Elastomers--Tension','' and by 
removing ``10850'' and by adding in its place ``20850''.


Sec. 801.430  [Amended]

    3. Section 801.430 ``User labeling for menstrual tampons'' is 
amended in paragraph (f)(2) by removing ``(ASTM) D 3492-96, `Standard 
Specification for Rubber Contraceptives (Male Condoms)''' and by adding 
in its place ``(ASTM) D 3492-97, `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 
20850, or at the Office of the Federal Register, 800 North Capitol St., 
NW., suite 700, Washington, DC.''

    Dated: June 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-18082 Filed 7-17-00; 8:45 am]
BILLING CODE 4160-01-F