Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules 3623

1The request was made in a January 3, 2000 letter

jointly signed by the American Farm Bureau

Federation, the American Soybean Association, the

National Association of Wheat Growers, the

National Cattlemen’s Beef Association, the National

Corn Grower’s Association, the National Farmers

Union, and the National Pork Producers Council.

with the applicable CFMI SB listed in

paragraph (b) of this AD.

Alternate Methods of Compliance

(d) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Engine

Certification Office (ECO). Operators shall

submit their request through an appropriate

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, ECO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained from the ECO.

Ferry Flights

(e) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the inspection requirements

of this AD can be accomplished.

Issued in Burlington, Massachusetts, on

January 14, 2000.

David A. Downey,

Assistant Manager, Engine and Propeller

Directorate, Aircraft Certification Service.

[FR Doc. 00–1641 Filed 1–21–00; 8:45 am]

BILLING CODE 4910–13–U

COMMODITY FUTURES TRADING

COMMISSION

17 CFR Part 1

RIN 3038–AB50

Proposed Revision of the

Commission’s Procedures for the

Review of Contract Market Rules

AGENCY: Commodity Futures Trading

Commission.

ACTION: Extension of comment period.

SUMMARY: On November 26, 1999, the

Commodity Futures Trading

Commission (‘‘Commission’’) published

in the Federal Register a request for

public comment on a proposal to revise

its procedures for the review of contract

market rules and rule amendments (64

FR 66428). The original comment period

expires January 25, 2000. By letter dated

January 3, 2000, seven agricultural

organizations requested a thirty day

extension of the comment period to

permit the membership of each

organization to fully consider the

implications of the proposed

procedures.1

The Commission has determined to

extend the comment period for thirty

days in order to insure that an adequate

opportunity is provided for submission

of meaningful comments.

EFFECTIVE DATE: Written comments must

be received on or before February 24,

2000.

ADDRESSES: Comments on the proposal

should be sent to Jean A. Webb,

Secretary, Commodity Futures Trading

Commission, Three Lafayette Center,

1155 21st Street, NW, Washington, DC

20581. Comments may be sent by

facsimile transmission to (202) 418–

5521, or by e-mail to secretary @cftc.gov.

Reference should be made to

‘‘Procedure for the Review of Contract

Market Rules’’.

FOR FURTHER INFORMATION CONTACT:

David P. Van Wagner, Associate

Director, Division of Trading and

Markets, Commodity Futures Trading

Commission, Three Lafayette Centre,

1155 21st Street, NW, Washington, DC

20581. Telephone Number: (202) 418–

5490. Facsimile Number: (202) 418–

5536. Electronic Mail: tm@cftc.gov.

Issued in Washington, D.C. on January 18,

2000 by the Commission.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 00–1568 Filed 1–21–00; 8:45 am]

BILLING CODE 6351–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 99N–3088]

RIN 0910–AB33

Marketing Exclusivity and Patent

Provisions for Certain Antibiotic Drugs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing

regulations to exempt marketing

applications for certain antibiotic drug

products from regulatory provisions

governing marketing exclusivity and

patents. The proposal would apply to

marketing applications for drug

products containing an antibiotic drug

that was the subject of a marketing

application received by FDA before

November 21, 1997, the effective date of

the Food and Drug Administration

Modernization Act of 1997

(Modernization Act). This action is

intended to bring the agency’s

regulations into conformance with

certain transitional provisions of the

Modernization Act. FDA is including in

the proposed regulation a list of the

active moieties of antibiotic drugs that

were the subjects of marketing

applications received by FDA before

November 21, 1997.

DATES: Written comments by April 24,

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:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. The Modernization Act

On November 21, 1997, the President

signed the Modernization Act (Public

Law 105–115). Section 125(b) of the

Modernization Act repealed section 507

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 357 (1996)).

Section 507 was the section of the act

under which the agency certified

antibiotic drugs. Section 125(b) of the

Modernization Act also made

conforming amendments to the act.

In the Federal Register of May 12,

1998 (63 FR 26066), and January 5, 1999

(64 FR 396), the agency issued

conforming amendments to its

regulations to remove provisions

governing certification of antibiotic

drugs (21 CFR parts 430 to 460) and to

make other changes needed to reflect

the repeal of section 507 of the act.

Section 125(d)(1) of the

Modernization Act provides that

marketing applications for antibiotic

drugs that were approved under former

section 507 of the act will be considered

to have been submitted and approved

under the new drug application (NDA)

submission and approval provisions

found at section 505(b) and (c) of the act

(21 U.S.C. 355(b) and (c)). If the

marketing application was an approved

abbreviated antibiotic drug application,

it will be considered to have been

submitted and approved under the

abbreviated new drug application

(ANDA) provisions found in section

505(j) of the act.

The Modernization Act also exempts

certain antibiotic-related drug marketing

applications from the marketing

exclusivity and patent provisions found

3624 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules

1The Modernization Act does not affect whatever

rights patent holders may have regarding patent

term extensions under 35 U.S.C. 156 for patents

claiming antibiotic drug products.

2The Modernization Act added a new section

505(j)(3) to the act. This resulted in the

renumbering of sections 505(j)(3) through (j)(8) as

sections 505(j)(4) through (j)(9), respectively.

in section 505 of the act.1 Under former

section 507 of the act, antibiotic drug

applications were not subject to the

patent listing and exclusivity provisions

in section 505 of the act. Section 125 of

the Modernization Act preserves this

distinction with an expansive line.

Section 125 exempts those applications

that contain an antibiotic drug that was

the subject of a marketing application

received by FDA under former section

507 of the act before November 21, 1997

(prerepeal antibiotic drugs). Drugs that

were approved and marketed under

former section 507 of the act, as well as

those that were the subject of

applications that may have been

withdrawn, not filed, or refused

approval under section 507 of the act

are excluded from the patent listing and

exclusivity provisions.

Specifically, section 125(d)(2) of the

Modernization Act provides that

marketing applications for drug

products that contain prerepeal

antibiotic drugs are not subject to the

following provisions of section 505 of

the act:

• The third and fourth sentences of

section 505(b)(1) (requiring submission

of patent information in NDA’s).

• Section 505(b)(2)(A) (requiring that

505(b)(2) applications contain patent

certifications).

• Section 505(b)(2)(B) (requiring that

applications submitted under section

505(b)(2) of the act (505(b)(2)

applications) contain a statement about

relevant method of use patents).

• Section 505(b)(3) (requiring

applicants submitting 505(b)(2)

applications (505(b)(2) applicants) to

provide notice to the patent owner and

NDA holder of the certification of

invalidity or noninfringement of a

patent).

• Section 505(c)(2) (requiring

submission of patent information if that

information becomes available after an

NDA is submitted).

• Section 505(c)(3) (providing for

delayed effective dates of approval of

505(b)(2) applications under patent

provisions of the act).

• Section 505(d)(6) (allowing FDA to

refuse to approve an application that

does not contain required patent

information).

• Section 505(e)(4) (requiring FDA to

withdraw approval of an application if

the applicant refuses to submit required

patent information).

• Section 505(j)(2)(A)(vii) and

(j)(2)(A)(viii) (requiring ANDA’s to

contain patent certifications or other

patent information).

• Section 505(j)(2)(B) (requiring

ANDA applicants to provide notice to

the patent owner and NDA holder of the

certification of invalidity or

noninfringement of a patent).

• Section 505(j)(5)(B) (providing for

delayed effective dates of approval of

ANDA’s under patent provisions of the

act).2

• Section 505(j)(5)(D) (describing

submission of and effective dates of

approval of ANDA’s under marketing

exclusivity provisions of the act).

Section 125(d)(3) of the

Modernization Act authorizes FDA to

make available to the public the

established name of each antibiotic drug

that was the subject of a marketing

application received by FDA under

former section 507 of the act before

November 21, 1997.

II. Description of the Rule

A. List of Regulatory Provisions That

Are Not Applicable

This proposed rule would exempt

from the regulatory requirements that

correspond to the statutory

requirements described above,

applications or abbreviated applications

in which the drug product that is the

subject of the application contains a prerepeal antibiotic drug. Specifically,

under the proposed rule, the following

provisions found in part 314 (21 CFR

part 314) would not apply to marketing

applications for drug products that

contain pre-repeal antibiotic drugs:

• Sections 314.50(h) and 314.53

(relating to submission of patent

information in NDA’s).

• Section 314.50(i) (relating to patent

certifications and statements about

relevant method of use patents in

505(b)(2) applications).

• Section 314.52 (relating to notices

to the patent owner and NDA holder of

certification of invalidity or

noninfringement of a patent by 505(b)(2)

applicants).

• Section 314.94(a)(12) (relating to

patent certifications and statements

about relevant method of use patents in

ANDA’s).

• Section 314.95 (relating to notices

to the patent owner and NDA holder of

certification of invalidity or

noninfringement of a patent by ANDA

applicants).

• Section 314.107(b) through (f)

(relating to delayed effective dates of

approval of ANDA’s and 505(b)(2)

applications under patent provisions of

the act).

• Section 314.108(b) (relating to

submission of and effective dates of

approval of ANDA’s and 505(b)(2)

applications under marketing

exclusivity provisions of the act).

• Section 314.125(b)(18) (relating to

refusal to approve an NDA that does not

contain required patent information).

• Section 314.150(a)(2)(v) (relating to

withdrawal of approval of an NDA if the

applicant refuses to submit required

patent information).

The brief parenthetical descriptions of

the various provisions of part 314 in this

section and in the codified portion of

this proposed rule (as well as the similar

descriptions of provisions of section 505

of the act given in section I of this

document) are provided merely as aids

to the reader in understanding the scope

of the proposed rule. They are not

intended to have any regulatory

significance and should not be

understood to be statements of agency

policy regarding the provisions they

describe.

B. List of Pre-Repeal of Antibiotic Drugs

In applying section 125(d)(2) of the

Modernization Act, the agency must

determine whether a drug that is the

subject of an NDA or ANDA contains a

pre-repeal antibiotic drug. As described

in section I, the Modernization Act

specifies patent listing and exclusivity

provisions that will not apply when the

drug that is the subject of any

application contains an antibiotic drug,

and the antibiotic drug was the subject

of any application received under

section 507 of the act prior to November

21, 1997. Section 125(d)(3) of the

Modernization Act also authorizes FDA

to publish the established name of each

antibiotic drug that was the subject of

any application for marketing received

by FDA under former section 507 of the

act.

The term ‘‘antibiotic drug,’’ as used in

section 125(d) of the Modernization Act,

is defined as:

* * * any drug (except drugs for use in

animals other than humans) composed

wholly or partly of any kind of penicillin,

streptomycin, chlortetracycline,

chloramphenicol, bacitracin, or any other

drug intended for human use containing any

quantity of any chemical substance which is

produced by a micro-organism and which

has the capacity to inhibit or destroy microorganisms in dilute solution (including a

chemically synthesized equivalent of any

such substance) or any derivative thereof.

21 U.S.C. 321(jj)

Thus, the term ‘‘antibiotic drug’’

includes not only the ‘‘chemical

substance which is produced by a

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules 3625

micro-organism,’’ and which ‘‘has the

capacity to inhibit or destroy microorganisms,’’ but also ‘‘any derivative’’ of

any such substance, such as a salt or

ester of the substance.

For this reason, and the reasons

discussed below, the determination

under section 125(d) of the

Modernization Act of whether a drug

contains a pre-repeal antibiotic depends

on whether the drug that is the subject

of a marketing application contains an

active moiety that can be found in a prerepeal antibiotic drug.

An active moiety is the molecule or

ion responsible for physiological or

pharmacological action, excluding

appended portions that would cause the

drug to be an ester, salt, or other

noncovalent derivative of the molecule

(see § 314.108(a)). FDA has consistently

looked at active moieties to determine if

the exclusivity protection granted to a

drug product would allow a subsequent

ANDA or application described in

section 505(b)(2) of the act to be

submitted or approved.

The agency’s primary regulation

governing marketing exclusivity is

found at § 314.108. This regulation,

which was proposed in the Federal

Register of July 10, 1989 (54 FR 28872),

and made final in the Federal Register

of October 3, 1994 (59 FR 50338),

incorporated an interpretation of the

Drug Price Competition and Patent

Term Restoration Act of 1984 (Public

Law 98–417) (the Hatch-Waxman

Amendments) that had been adopted by

the agency shortly after the enactment of

the Hatch-Waxman Amendments on

September 24, 1984. The HatchWaxman Amendments established the

exclusivity and patent provisions that

are addressed by the exemptions

described in section 125(d)(2) of the

Modernization Act, and are the subject

of this rulemaking. In interpreting the

exclusivity provisions in the HatchWaxman Amendments, the agency

concluded that Congress did not intend

to confer significant periods of

exclusivity on minor variations of

previously approved chemical

compounds. (See, e.g., Congressional

Record H9124 (September 6, 1984)

(statement of Representative Waxman);

H. Rept. 857, Part I, 98th Cong., 2d sess.

38 (1984).) Therefore, the agency

determined that it is appropriate to

assess whether the drug seeking

exclusivity is a new chemical entity,

that is, a drug that does not contain any

previously approved active moiety.

This approach is also consistent with

FDA’s drug classification system, which

assesses and classifies NDA’s based

upon the characteristics of the active

ingredient or ingredients of the product.

(See 54 FR 28872 at 28897.)

The language of section 125(d)(2) of

the Modernization Act likewise

supports the conclusion that Congress

did not intend to confer exclusivity on,

or require patent listing for, products

that represent minor or incremental

variations on pre-repeal antibiotic

drugs. As discussed above, Congress in

section 125(d)(2) of the Modernization

Act chose to exclude all drugs

containing pre-repeal ‘‘antibiotic

drugs,’’ a term that by definition

includes the active drug substance and

‘‘any derivative thereof’’ (see section

201(jj) of the act (21 U.S.C. 321(jj)).

Accordingly, the agency is proposing

to implement section 125(d)(2) of the

Modernization Act by relying on a

comparison of active moieties to

determine whether the drug that is the

subject of an NDA contains a pre-repeal

antibiotic drug. NDA’s for products that

contain, for example, a salt of a prerepeal antibiotic drug, or that propose

such things as a new manufacturing

process, new dosage form, or new use of

a pre-repeal antibiotic drug, will be

subject to the exceptions listed in

section 125(d)(2) of the Modernization

Act and proposed § 314.109(a).

To help interested persons determine

which drug products would be exempt

from the marketing exclusivity and

patent provisions described above, FDA

will maintain in the Code of Federal

Regulations a list of the names of each

pre-repeal active moiety. A proposed

version of that list is included as

§ 314.109(b).

The list will provide all of the

information required for an interested

person to determine whether a

marketing application is for a drug that

contains a pre-repeal antibiotic drug.

The list is intended to be

comprehensive, but the inadvertent

omission of an active moiety found in

a pre-repeal antibiotic drug will not

affect the regulatory status of a

marketing application for a drug that

contains that active moiety; the

application will still be exempt from the

statutory and regulatory requirements

regarding marketing exclusivity and

patents described above. A person who

believes that a drug has been improperly

included or omitted from the list should

submit to the Dockets Management

Branch (address above) written

comments suggesting amendments to

the list, along with any information that

supports the suggested amendments.

Comments should be identified with the

docket number found in brackets in the

heading of this document.

III. Environmental Impact

The agency has determined under 21

CFR 25.30(h) 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, the Regulatory Flexibility Act (5

U.S.C. 601–612), and the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4). 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 agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. Because, the

proposed rule is a significant regulatory

action as defined by the Executive Order

and it was subject to review under the

Executive Order.

The Regulatory Flexibility Act

requires that if a rule has a significant

economic impact on a substantial

number of small entities, the agency

must analyze regulatory options to

minimize the economic impact on small

entities. The agency certifies, for the

reasons discussed below, that the

proposed rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

The Unfunded Mandates Reform Act

requires an agency to prepare a

budgetary impact statement before

issuing any rule likely to result in a

Federal mandate that may result in

expenditures by State, local, and tribal

governments or the private sector of

$100 million (adjusted annually for

inflation) in any one year. Exempting

applications for certain antibiotic drugs

from regulatory provisions dealing with

marketing exclusivity and patent

information will not result in any

3626 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules

increased expenditures by State, local,

and tribal governments or the private

sector. Because this proposed rule will

not result in an expenditure of $100

million or more by any governmental

entity or the private sector, no budgetary

impact statement is required.

This proposed rule is intended to

bring FDA’s regulations governing the

new drug approval process into

conformance with the transitional

provisions found in section 125(d)(2) of

the Modernization Act. This proposed

rule is not intended to create any rights

or responsibilities that are not found in

the statute. For these reasons, the

agency believes that this proposed rule

is necessary and that it is consistent

with the principles of Executive Order

12866; that it is not a significant

regulatory action under that Executive

Order; that it will not have a significant

economic impact on a substantial

number of small entities; and that it is

not likely to result in an annual

expenditure in excess of $100 million.

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.

VI. Request for Comments

Interested persons may, on or before

April 24, 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 314

Administrative practice and

procedure, Confidential business

information, Drugs, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 314 be amended as follows:

PART 314—APPLICATIONS FOR FDA

APPROVAL TO MARKET A NEW DRUG

1. The authority citation for 21 CFR

part 314 is revised to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 371, 374, 379e; sec. 125(d), Pub. L.

105–115, 111 Stat. 2296.

2. Add § 314.109 to subpart D to read

as follows:

§ 314.109 Marketing exclusivity and patent

provisions not applicable to certain

antibiotic-related drug marketing

applications.

(a) The following regulatory

provisions do not apply to any

application or abbreviated application

in which the drug that is the subject of

the application or abbreviated

application contains an antibiotic drug

that has the same active moiety (as

defined in § 314.108(a)) as an antibiotic

drug that was the subject of a marketing

application received by FDA under

former section 507 of the act (21 U.S.C.

357 (1996)) before November 21, 1997:

(1) Sections 314.50(h) and 314.53

(relating to submission of patent

information in applications).

(2) Section 314.50(i) (relating to

patent certifications and statements

about relevant method of use patents in

505(b)(2) applications).

(3) Section 314.52 (relating to notices

of certification of invalidity or

noninfringement of a patent by 505(b)(2)

applicants).

(4) Section 314.94(a)(12) (relating to

patent certifications and statements

about relevant method of use patents in

505(j) applications).

(5) Section 314.95 (relating to notices

of certification of invalidity or

noninfringement of a patent by 505(j)

applicants).

(6) Section 314.107(b) through (f)

(relating to delayed effective dates of

approval of 505(j) applications and

505(b)(2) applications under patent

provisions of the act).

(7) Section 314.108(b) (relating to

submission of and effective dates of

approval of 505(j) applications and

505(b)(2) applications under marketing

exclusivity provisions of the act).

(8) Section 314.125(b)(18) (relating to

refusal to approve an application that

does not contain required patent

information).

(9) Section 314.150(a)(2)(v) (relating

to withdrawal of approval of an

application if the applicant refuses to

submit required patent information).

(b) The following are the active

moieties of antibiotic drugs that were

the subject of marketing applications

received by FDA under former section

507 of the act before November 21,

1997. The list is intended to be

comprehensive, but the inadvertent

omission of an active moiety will not

affect the regulatory status of a

marketing application for a drug

product that contains that active moiety.

Almecillin

Amdinocillin

Amikacin

Amoxicillin

Amphomycin

Amphotericin B

Ampicillin

Azacitidine

Azaserine

Azithromycin

Azlocillin

Aztreonam

Bacampicillin

Bacitracin

Benzyl penicilloyl-polylysine

Bleomycin

Candicidin

Capreomycin

Carbenicillin

Cefaclor

Cefadroxil

Cefamandole

Cefazolin

Cefdinir

Cefepime

Cefixime

Cefmenoxime

Cefmetazole

Cefodizime

Cefonicid

Cefoperazone

Ceforanide

Cefotaxime

Cefotetan

Cefotiam

Cefoxitin

Cefpiramide

Cefpodoxime

Cefprozil

Cefsulodin

Ceftazidime

Ceftibuten

Ceftizoxime

Ceftriaxone

Cefuroxime

Cephacetrile

Cephalexin

Cephaloglycin

Cephaloridine

Cephalothin

Cephapirin

Cephradine

Chloramphenicol

Chlortetracycline

Cilastatin

Clarithromycin

Clavulanate/clavulanic acid

Clindamycin

Clioquinol

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules 3627

Cloxacillin

Colistimethate

Colistin

Cyclacillin

Cycloserine

Cyclosporine

Dactinomycin

Dalfopristin

Daunorubicin

Demeclocycline

Detorubicin

Dicloxacillin

Dihydrostreptomycin

Dirithromycin

Doxorubicin

Doxycycline

Epirubicin

Erythromycin

Floxacillin

Fosfomycin

Fusidate/fusidic acid

Gentamicin

Gramicidin

Griseofulvin

Hetacillin

Idarubicin

Imipenem

Ivermectin

Kanamycin

Lincomycin

Loracarbef

Meclocycline

Meropenem

Methacycline

Methicillin

Mezlocillin

Minocycline

Mitomycin

Moxalactam

Mupirocin

Mycophenolate/mycophenolic acid

Nafcillin

Natamycin

Neomycin

Netilmicin

Niphimycin

Novobiocin

Nystatin

Oleandomycin

Oxacillin

Oxytetracycline

Paromomycin

Penicillamine

Penicillin G

Penicillin V

Phenethicillin

Piperacillin

Plicamycin

Polymyxin B

Quinupristin

Rifabutin

Rifampin

Rifamycin

Rolitetracycline

Sisomicin

Spectinomycin

Streptomycin

Streptozocin

Sulbactam

Sultamicillin

Tacrolimus

Tazobactam

Teicoplanin

Tetracycline

Ticarcillin

Tobramycin

Troleandomycin

Tyrothricin

Vancomycin

Vidarabine

Viomycin

Dated: October 5, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1536 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

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