26066 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

• The total number of flight cycles

accumulated on the airplane;

• A description of the area of the wiring

where the sleeving was missing; and

• A description of the damage found.

Information collection requirements

contained in this regulation have been

approved by the Office of Management and

Budget (OMB) under the provisions of the

Paperwork Reduction Act of 1980 (44 U.S.C.

3501 et seq.) and have been assigned OMB

Control Number 2120–0056.

(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, Seattle

ACO. Operators shall submit their requests

through an appropriate FAA Principal

Maintenance Inspector, who may add

comments and then send it to the Manager,

Seattle ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(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 requirements of this AD

can be accomplished.

(f) The actions shall be done in accordance

with Boeing Message M–7200–98–01080,

dated March 18, 1998. This incorporation by

reference was approved by the Director of the

Federal Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may be

obtained from Boeing Commercial Airplane

Group, P.O. Box 3707, Seattle, Washington

98124–2207. Copies may be inspected at the

FAA, Transport Airplane Directorate, 1601

Lind Avenue, SW., Renton, Washington; or at

the Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(g) This amendment becomes effective on

May 27, 1998.

Issued in Renton, Washington, on May 5,

1998.

John J. Hickey,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–12512 Filed 5–11–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 430, 431, 432, 433, 436,

440, 441, 442, 443, 444, 446, 448, 449,

450, 452, 453, 455, and 460

[Docket No. 98N–0211]

Removal of Regulations Regarding

Certification of Antibiotic Drugs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is repealing its

regulations governing certification of

antibiotic drugs. The agency is taking

this action in accordance with

provisions of the Food and Drug

Administration Modernization Act of

1997 (FDAMA). FDAMA repealed the

statutory provision in the Federal Food,

Drug, and Cosmetic Act (the act) under

which the agency certified antibiotic

drugs. FDAMA also made conforming

amendments to the act.

DATES: The direct final rule is effective

September 24, 1998. Submit written

comments on or before July 27, 1998. If

no timely significant adverse comments

are received, the agency will publish a

document in the Federal Register before

August 25, 1998, confirming the

effective date of the direct final rule. If

timely significant adverse comments are

received, the agency will publish a

document of significant adverse

comment in the Federal Register

withdrawing this direct final rule before

August 25, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell or Christine F.

Rogers, Center for Drug Evaluation and

Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–2041.

SUPPLEMENTARY INFORMATION:

I. FDAMA

On November 21, 1997, the President

signed FDAMA (Pub. L. 105–115).

Section 125(b) of FDAMA repealed

section 507 of the act (21 U.S.C. 357).

Section 507 of the act was the section

under which the agency certified

antibiotic drugs. Section 125(b) of

FDAMA also made conforming

amendments to the act.

FDA has determined that it will be

most efficient to make changes in its

regulations to reflect the repeal of

section 507 of the act in phases. In this

first phase, this direct final rule removes

parts 430 through 460 (21 CFR parts 430

through 460). These regulations provide

the procedures and standards used to

certify antibiotic drugs, including FDA’s

antibiotic drug monographs. FDA plans

to initiate a second phase direct final

rulemaking procedure to make various,

noncontroversial conforming

amendments to the balance of Title 21

of the Code of Federal Regulations

(CFR), such as removing citations to

section 507 of the act and references to

the certification of antibiotics. The

agency recognizes that as it implements

the transition from regulating the

premarket review and approval of

antibiotic drugs under section 507 of the

act to section 505 of the act (21 U.S.C.

355), other issues may arise that could

require additional rulemaking. These

issues will be addressed in the third

phase of implementation.

II. Direct Final Rulemaking

FDA has determined that the subject

of this rulemaking is suitable for a direct

final rule. The repeal of section 507 of

the act eliminates the statutory

provision on which the agency relied to

certify antibiotic drugs. FDA will,

therefore, remove all provisions of Title

21 of the CFR that were issued primarily

to carry out the agency’s program for the

certification of antibiotic drugs under

former section 507 of the act. The

actions taken should be

noncontroversial and the agency does

not anticipate receiving any significant

adverse comments on this rule.

If FDA does not receive significant

adverse comment on or before July 27,

1998, the agency will publish a

document in the Federal Register before

August 25, 1998, confirming the

effective date of the direct final rule. A

significant adverse comment is one 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 a change. A

comment recommending a rule change

in addition to this rule will not be

considered a significant adverse

comment, unless the comment states

why this rule would be ineffective

without the additional change. If timely

significant adverse comments are

received, the agency will publish a

notice of significant adverse comment in

the Federal Register withdrawing this

direct final rule before August 25, 1998.

Elsewhere in this issue of the Federal

Register, FDA is publishing a

companion proposed rule, which is

identical to the direct final rule, that

provides a procedural framework within

which the rule may be finalized in the

event the direct final rule is withdrawn

because of significant adverse comment.

The comment period for the direct final

rule runs concurrently with that of the

companion proposed rule. Any

comments received under the

companion proposed rule will be

treated as comments regarding the direct

final rule. Likewise, significant adverse

comments submitted to the direct final

rule will be considered as comments to

the companion proposed rule and the

agency will consider such comments in

developing a final rule. FDA will not
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26067

provide additional opportunity for

comment on the companion proposed

rule.

If a significant adverse comment

applies to part of this rule and that part

may be severed from the remainder of

the rule, FDA may adopt as final those

parts of the rule that are not the subject

of a significant adverse comment. A full

description of FDA’s policy on direct

final rule procedures may be found in

a guidance document published in the

Federal Register of November 21, 1997

(62 FR 62466).

III. Description of the Rule

This rule eliminates Part 430—

Antibiotic Drugs; General, in its

entirety. Part 430 provided definitions

used in the certification of antibiotic

drugs and contains § 430.10, which

carried out former section 507(h) of the

act and was intended to address the

certification or release of antibiotic

drugs affected by the Drug Amendments

of 1962 (Pub. L. 87–781).

This rule also eliminates Part 431—

Certification of Antibiotic Drugs, which

provided various administrative and

procedural requirements for the

antibiotic certification program,

established conditions on the

effectiveness of a certification issued by

the agency, and set the fees needed to

maintain the agency’s antibiotic

certification program (see former section

507(b) of the act). Subpart D of Part

431—Confidentiality of Information, is

also being eliminated because it is

duplicative of the provisions in 21 CFR

312.130 governing the disclosure of

information in or about an

investigational new drug application.

Part 433—Exemptions from Antibiotic

Certification and Labeling Requirements

is removed by this rule. Part 433 set the

conditions for exempting antibiotic

drugs from the general requirement of

certification as well as from other, more

specific, regulatory requirements (see

former section 507(c) and (d) of the act).

This rule eliminates Part 436—Tests

and Methods of Assay of Antibiotic and

Antibiotic-Containing Drugs. Part 436

contained sterility test methods,

biological test methods, microbiological

assay methods, and chemical tests for

antibiotic drugs generally and for

specific antibiotic drugs and antibiotic

drug dosage forms. These tests and

methods of assay established the means

by which the agency would certify that

a given batch of antibiotic drug was in

compliance with applicable standards of

identity, strength, quality, and purity

(see former section 507(a) and (b) of the

act).

This rule also repeals the following

parts: Part 440—Penicillin Antibiotic

Drugs; Part 441—Penem Antibiotic

Drugs; Part 442—Cepha Antibiotic

Drugs; Part 443—Carbacephem

Antibiotic Drugs; Part 444—

Oligosaccharide Antibiotic Drugs; Part

446—Tetracycline Antibiotic Drugs; Part

448—Peptide Antibiotic Drugs; Part

449—Antifungal Antibiotic Drugs; Part

450—Antitumor Antibiotic Drugs; Part

452—Macrolide Antibiotic Drugs; Part

453—Lincomycin Antibiotic Drugs; Part

455—Certain Other Antibiotic Drugs;

and Part 460—Antibiotic Drugs

Intended for Use in Laboratory

Diagnosis of Disease. These parts

contain the standards of identity,

strength, quality, and purity that served

as the agency’s basis for batch certifying

or otherwise authorizing the marketing

of drugs that were subject to former

section 507 of the act, including the

classes of penicillin; penem; cepha;

carbacephem; oligosaccharide;

tetracycline; peptide; antifungal;

antitumor; macrolide; and lincomycin

antibiotic drugs; several antibiotic drugs

not included in the parts listed above;

and antibiotic susceptibility discs,

powders, and test panels, respectively

(see former section 507(a) and (b) of the

act).

With the repeal of part 436 and parts

440 et seq., the test methods and assays

contained in the approved marketing

application and, when applicable, the

United States Pharmacopeia (USP) will

be used to determine if antibiotic drugs

meet the standards of identity, strength,

quality, and purity found in the

approved marketing application for the

drug and, when applicable, the USP.

Finally, the agency is eliminating Part

432—Packaging and Labeling of

Antibiotic Drugs, which sets forth

special packaging requirements and

additional labeling requirements (in

addition to the requirements prescribed

by 21 CFR 201.100) for drugs that were

subject to batch certification or release

under former section 507 of the act.

With the repeal of section 507 of the act,

there is no need to maintain separate or

additional labeling and packaging

requirements for antibiotic drug

products. As with other drug products,

labeling of antibiotic drugs will be

governed by the agency’s general

labeling provisions found in 21 CFR

part 201 and by applicable over-thecounter drug monographs and approved

marketing applications.

Part 432 also included § 432.9, which

conditionally authorized the batch

certification of antibiotic drugs intended

for export, even if the drug failed to

meet certain labeling requirements, and

provided additional guidance on the

labeling of antibiotic drugs for export. In

light of the repeal of the batch

certification requirement, § 432.9 may

also be eliminated without affecting the

export of antibiotic drug products.

It should be noted, however, that

differences remain between the

application of the export provisions in

sections 801 and 802 of the act (21

U.S.C. 381 and 382) to antibiotic drugs

and the application of those provisions

to other new drugs. Prior to the repeal

of section 507 of the act, these

differences were based on the fact that

antibiotic drugs were not subject to

premarket approval under section 505

and, therefore, could be exported under

section 801(e)(1) of the act. Antibiotic

drugs did not have to meet the export

requirements in section 802 that apply

to unapproved new drugs. Thus,

manufacturers could export antibiotic

drugs that had not been certified,

released, or exempted from certification,

subject only to the provisions of section

801(e)(1) of the act. Section 125(c) of

FDAMA preserved the export status of

antibiotic drugs (which are now subject

to approval under section 505 of the act)

by expressly exempting them from

section 802. (Section 125(c) of FDAMA

included the same exemption for

insulin products.) In the second phase

of the implementation of section 125 of

FDAMA, the agency will consider

making appropriate amendments to its

regulations to reflect this difference

between the application of the export

provisions of the act to antibiotic drugs

(and insulin products) as opposed to all

other new drugs.

The removal of parts 430 et seq. is not

expected to result in any immediate,

significant changes in the

manufacturing, packaging, labeling, or

marketing of antibiotic drug products.

Since 1982, the agency has

conditionally exempted all antibiotic

drugs from batch certification (47 FR

39155, September 7, 1982). With limited

exceptions, such as in the areas of

export and generic drug approvals, the

agency has imposed much the same

regulatory requirements on exempted

antibiotic drug products as it has on all

other drug products.

IV. 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.

V. Analysis of Impacts

FDA has examined the impacts of the

direct final rule under Executive Order

12866, the Regulatory Flexibility Act (5
26068 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

U.S.C. 601–612), and the Unfunded

Mandates Reform Act of 1995 (Pub. L.

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. As

discussed below, the agency believes

that this final rule is consistent with the

regulatory philosophy and principles

identified in the Executive Order. In

addition, the direct final rule is not a

significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires that if a rule has a significant

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 direct final

rule will not have a significant 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 1 year. The elimination

of the regulations governing the

certification of antibiotic drugs will not

result in any increased expenditures by

State, local, and tribal governments or

the private sector. Because this rule will

not result in an expenditure of $100

million or more on any governmental

entity or the private sector, no budgetary

impact statement is required.

This rule is intended to eliminate

regulatory procedures and standards

that the agency, as a result of the repeal

of section 507 of the act, is no longer

required to maintain. The elimination of

the above listed parts is expected to

streamline the regulation of antibiotic

drugs by making these products subject

to the same regulatory standards as all

other drugs for human use. Many of the

provisions that are being eliminated by

this rulemaking have not had a material

impact on the marketing of antibiotic

drugs since 1982, when all antibiotic

drugs were conditionally exempted

from the batch certification requirement.

Other provisions, such as the standards

of identity, strength, quality, and purity,

have in some instances not been kept

up-to-date, are duplicative of USP

standards, or have been incorporated

into approved marketing applications

for specific antibiotic drug products. For

these reasons, the agency believes that

this 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

Order; that it will not have a significant

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.

VI. Paperwork Reduction Act of 1995

This direct final rule contains no

collection of information. Therefore,

clearance by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995 (Pub. L. 104–13)

is not required.

VII. Request for Comments

Interested persons may, on or before

July 27, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this 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.

List of Subjects

21 CFR Part 430

Administrative practice and

procedure, Antibiotics.

21 CFR Part 431

Administrative practice and

procedure, Antibiotics, Confidential

business information, Reporting and

recordkeeping requirements.

21 CFR Part 432

Antibiotics, Labeling, Packaging and

containers.

21 CFR Part 433

Antibiotics, Labeling, Reporting and

recordkeeping requirements.

21 CFR Parts 436, 440, 441, 442, 443,

444, 446, 448, 449, 450, 452, 453, 455,

and 460

Antibiotics.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Food and

Drug Administration Modernization

Act, and under authority delegated to

the Commissioner of Food and Drugs,

21 CFR chapter I is amended as follows:

PART 430—ANTIBIOTIC DRUGS;

GENERAL

1. Part 430 is removed.

PART 431—CERTIFICATION OF

ANTIBIOTIC DRUGS

2. Part 431 is removed.

PART 432—PACKAGING AND

LABELING OF ANTIBIOTIC DRUGS

3. Part 432 is removed.

PART 433—EXEMPTIONS FROM

ANTIBIOTIC CERTIFICATION AND

LABELING REQUIREMENTS

4. Part 433 is removed.

PART 436—TESTS AND METHODS OF

ASSAY OF ANTIBIOTIC AND

ANTIBIOTIC-CONTAINING DRUGS

5. Part 436 is removed.

PART 440—PENICILLIN ANTIBIOTIC

DRUGS

6. Part 440 is removed.

PART 441—PENEM ANTIBIOTIC

DRUGS

7. Part 441 is removed.

PART 442—CEPHA ANTIBIOTIC

DRUGS

8. Part 442 is removed.

PART 443—CARBACEPHEM

ANTIBIOTIC DRUGS

9. Part 443 is removed.

PART 444—OLIGOSACCHARIDE

ANTIBIOTIC DRUGS

10. Part 444 is removed.

PART 446—TETRACYCLINE

ANTIBIOTIC DRUGS

11. Part 446 is removed.

PART 448—PEPTIDE ANTIBIOTIC

DRUGS

12. Part 448 is removed.

PART 449—ANTIFUNGAL ANTIBIOTIC

DRUGS

13. Part 449 is removed.

PART 450—ANTITUMOR ANTIBIOTIC

DRUGS

14. Part 450 is removed.
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26069

PART 452—MACROLIDE ANTIBIOTIC

DRUGS

15. Part 452 is removed.

PART 453—LINCOMYCIN ANTIBIOTIC

DRUGS

16. Part 453 is removed.

PART 455—CERTAIN OTHER

ANTIBIOTIC DRUGS

17. Part 455 is removed.

PART 460—ANTIBIOTIC DRUGS

INTENDED FOR USE IN LABORATORY

DIAGNOSIS OF DISEASE

18. Part 460 is removed.

Dated: May 1, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12543 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 98N–0170]

Medical Device Reporting:

Manufacturer Reporting, Importer

Reporting, User Facility Reporting, and

Distributor Reporting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations governing reporting by

manufacturers, importers, distributors,

and health care (user) facilities of

adverse events related to medical

devices. Amendments are being made to

implement revisions to the Federal

Food, Drug, and Cosmetic Act (the act)

as amended by the Food and Drug

Administration Modernization Act of

1997 (FDAMA). FDA is publishing these

amendments in accordance with its

direct final rule procedures. 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 the agency

receives a significant adverse comment

and withdraws this direct final rule.

DATES: This rule is effective September

24, 1998. Submit written comments on

or before July 27, 1998. Submit written

comments on the information collection

requirements on or before July 13, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Patricia A. Spitzig, Center for Devices

and Radiological Health (HFZ–500),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

594–2812.

SUPPLEMENTARY INFORMATION:

I. Background

Under the act and the Medical Device

Amendments of 1976 (the 1976

amendments) (Pub. L. 94–295), FDA

issued medical device reporting

regulations for manufacturers on

September 14, 1984 (49 FR 36326). To

correct weaknesses noted in the 1976

amendments, and to better protect the

public health by increasing reports of

device-related adverse events, Congress

enacted the Safe Medical Devices Act of

1990 (the SMDA) (Pub. L. 101–629) that

required medical device user facilities

and distributors to report certain devicerelated adverse events.

Distributor reporting requirements

became effective on May 28, 1992,

following the November 26, 1991 (56 FR

60024), publication of those provisions

in a tentative final rule. In the Federal

Register of September 1, 1993 (58 FR

46514), FDA published a notice

announcing that the proposed

distributor reporting regulations had

become final by operation of law and

were now codified in part 804 (21 CFR

part 804).

On June 16, 1992, the President

signed into law the Medical Device

Amendments of 1992 (the 1992

amendments) (Pub. L. 102–112)

amending certain provisions of section

519 of the act (21 U.S.C. 360i) relating

to reporting of adverse device events.

Prior to the 1992 amendments,

distributors and manufacturers reported

adverse events by using a ‘‘reasonable

probability’’ standard. Importers may be

manufacturers or distributors,

depending on their activities. Among

other things, the 1992 amendments

amended section 519 of the act to

change the reporting standard for

manufacturers and importers; however,

the reporting standard for distributors

who are not importers remained the

same.

On November 21, 1997, the President

signed FDAMA into law. FDAMA made

several changes regarding the reporting

of adverse events related to devices,

including the elimination of reporting

requirements for certain distributors,

which became effective on February 19,

1998, that are reflected in this direct

final rule. However, section 422 of

FDAMA states that FDA’s regulatory

authority under the act, relating to

tobacco products, tobacco ingredients,

and tobacco additives shall be exercised

under the act as in effect on the day

before the date of enactment of FDAMA.

Because the authority relating to tobacco

products remains the same, the

reporting requirements for

manufacturers and distributors

(including distributors who are

importers) of cigarettes or smokeless

tobacco remain unchanged.

Under part 897, the regulations

pertaining to tobacco products, and

parts 803 (21 CFR part 803) and 804, the

regulations pertaining to device adverse

event reporting, importers may be either

manufacturers or distributors,

depending on their activities. Under

parts 897, 803, and 804, importers who

repackage or relabel are manufacturers.

Similarly, under those sections,

importers whose sole activity is

distribution of devices are defined as

distributors.

As previously stated, the 1992

amendments created a bifurcated

reporting standard for distributors,

depending on whether they are

domestic distributors or importers.

When the agency asserted jurisdiction

over tobacco products and issued

regulations under part 897, tobacco

distributors also became subject to this

bifurcated reporting standard.

Accordingly, the reporting standard

applicable to tobacco products

distributors has depended on whether

the distributor is domestic or an

importer. Consistent with section 422 of

FDAMA, the direct final rule states that

tobacco distributors will continue to use

the appropriate reporting standard as

described in § 804.25.

Changes made by FDAMA relating to

reporting requirements for all medical

devices other than tobacco products are

as follows:

1. Section 213(a) of FDAMA revised

section 519(a) of the act to eliminate

distributors as an entity required to

report adverse device events. Importers

are still required to report under section

519(a) of the act.

2. Section 213(a) also amended

section 519(a) of the act to clarify that

existing requirements continue to apply

for distributors to keep records

concerning adverse device events and

make them available to FDA upon

request.

3. Section 213(a)(2) revoked section

519(d) of the act, which required

manufacturers, importers, and

distributors to submit to FDA an annual

certification concerning the number of