Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules 66665

Federal Register. Therefore, a comment

to OMB is best assured of having its full

effect if OMB receives it within 30 days

of publication. This does not affect the

deadline for the public to comment to

the Commission on the proposed

regulations. Copies of the information

collection submission to OMB are

available from the CFTC Clearance

Officer, 1155 21st Street N.W.,

Washington, DC 20581, (202) 418–5160.

List of Subjects in 17 CFR Part 4

Brokers, Commodity futures.

In consideration of the foregoing and

pursuant to the authority contained in

the Commodity Exchange Act and in

particular sections 2(a)(1), 4l, 4m, 4n,

4o, and 8a, 7 U.S.C. 2, 6l, 6m, 6n, 6o,

and 12(a), the Commission hereby

proposes to amend Chapter I of Title 17

of the Code of Federal Regulations as

follows:

PART 4—COMMODITY POOL

OPERATORS AND COMMODITY

TRADING ADVISORS

1. The authority citation for part 4

continues to read as follows:

Authority: 7 U.S.C. 1a, 2, 4, 6b, 6c, 6l, 6m,

6n, 6o, 12a, and 23.

2. Section 4.22 is amended by:

a. redesignating paragraphs (f)(1)

introductory text, (f)(1)(i), (f)(1)(ii),

(f)(1)(iii), and (f)(1)(iv) as (f)(1)(i)

introductory text, (f)(1)(i)(A), (f)(1)(i)(B),

(f)(1)(i)(C), and (f)(1)(i)(D);

b. redesignating paragraphs (f)(2)

introductory text, (f)(2)(i), and (f)(2)(ii)

as (f)(1)(ii) introductory text, (f)(1)(ii)(A),

and (f)(1)(ii)(B);

c. redesignating paragraphs (f)(3)

introductory text, (f)(3)(i), and (f)(3)(ii)

as (f)(1)(iii) introductory text,

(f)(1)(iii)(A), and (f)(1)(iii)(B); and

d. adding a new paragraph (f)(2) to

read as follows:

§ 4.22 Reporting to pool participants.

* * * * *

(f) * * *

(2) In the event a commodity pool

operator finds that it cannot obtain

information necessary to prepare

certified financial statements for a pool

that it operates within the time specified

in either paragraph (c) of this section or

§4.7(b)(3)(i), as a result of the pool

investing in another collective

investment vehicle, it may claim an

extension of time under the following

conditions:

(i) The commodity pool operator

must, within 90 calendar days of the

end of the pool’s fiscal year, file a notice

with National Futures Association and

the Commission, except as provided in

paragraph (f)(2)(v) of this section.

(ii) The notice must contain the name,

main business address, main telephone

number and the National Futures

Association registration identification

number of the commodity pool operator,

and name and the identification number

of the commodity pool.

(iii) The notice must state the date by

which the Annual Report will be

distributed and filed (the ‘‘Extended

Date’’), which must be no more than 150

calendar days after the end of the pool’s

fiscal year. The Annual Report must be

distributed and filed by the Extended

Date.

(iv) The notice must include

representations by the commodity pool

operator that:

(A) The pool for which the Annual

Report is being prepared has

investments in one or more collective

investment vehicles (the

‘‘Investments’’);

(B) The commodity pool operator has

been informed by the certified public

accountant selected to audit the

commodity pool’s financial statements

that specified information establishing

the value of the Investments is

necessary in order for the accountant to

render an opinion on the commodity

pool’s financial statements. The notice

must include the name of the

accountant; and

(C) The information specified by the

accountant cannot be obtained in

sufficient time for the Annual Report to

be prepared, audited, and distributed

before the Extended Date.

(v) For each fiscal year following the

filing of the notice described in

paragraph (f)(2)(i) of this section, the

commodity pool operator may claim the

extension of time by filing a statement

containing the representations specified

in paragraph (f)(2)(iv) of this section, at

the same time as the pool’s annual

report.

(vi) Any notice or statement filed

pursuant to paragraph (f)(2) of this

section must be signed by the

commodity pool operator in accordance

with paragraph (h) of this section.

* * * * *

Issued in Washington, D.C. on October 31,

2000 by the Commission.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 00–28367 Filed 11–6–00; 8:45 am]

BILLING CODE 6351–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 00N–1545]

Applications for FDA Approval to

Market a New Drug; Proposed Revision

of Postmarketing Reporting

Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations describing

postmarketing reporting requirements to

implement certain provisions of the

Food and Drug Administration

Modernization Act of 1997 (the

Modernization Act). The proposed

changes apply to drug products that are

life supporting, life sustaining, or

intended for use in the prevention of a

serious disease or condition and that

were not originally derived from human

tissue and replaced by a recombinant

product. The proposed rule would

implement provisions of the

Modernization Act by requiring an

applicant who is the sole manufacturer

of one of these products to notify FDA

at least 6 months before discontinuing

manufacture of the drug product.

DATES: Submit written comments by

February 5, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance for

industry referred to in this proposed

rule. Submit written requests for single

copies of the guidance referred to in this

proposal to the Drug Information Branch

(HFD–210), Center for Drug Evaluation

and Research (CDER), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857; or the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, FAX 1–888–

CBERFAX or 301–827–3844. Send two

self-addressed adhesive labels to assist

the office in processing your request.

Requests should be identified with the

66666 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Andrea C. Masciale, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Introduction

On November 21, 1997, President

Clinton signed into law the

Modernization Act (Public Law 105–

115). Section 131 of the Modernization

Act amends the Federal Food, Drug, and

Cosmetic Act (the act) by codifying new

section 506C (21 U.S.C. 356c). Section

506C of the act requires manufacturers

who are the sole manufacturers of

certain drug products to notify us (FDA)

at least 6 months before discontinuing

manufacture of the products. We may

reduce the 6-month notification period

if good cause exists for the reduction.

Under section 506C of the act, we must

provide information to the public about

the product discontinuance. The

proposed revisions to our postmarketing

reporting requirements described in this

notice are intended to implement these

new provisions of the act.

A presidential memoradum on plain

language (June 1, 1998) directs each

agency to write regulations that are

simple and easy to understand. As a

result, we prepared this proposed

regulation consistent with our plain

language initiative. Please send any

comments you have on the clarity of the

regulations to the Dockets Management

Branch (address above).

II. Section 506C of the Act

Section 506C(a) of the act requires

sole manufacturers of a drug product

that meets the following three criteria to

notify us at least 6 months before

discontinuing manufacture of the

product:

1. The product must be life

supporting, life sustaining, or intended

for use in the prevention of a

debilitating disease or condition;

2. The product must have been

approved under section 505(b) or (j) of

the act (21 U.S.C. 355(b) or (j)); and

3. The product must not have been

originally derived from human tissue

and replaced by a recombinant product.

Under section 506C(b) of the act, we

may reduce the 6-month notification

period required under section 506C(a) if

the manufacturer who seeks our

reduction of the notification period

certifies to us that good cause exists for

the reduction. Section 506C(b) of the act

provides examples of situations where

good cause exists as follows:

• A public health problem may result

from continuation of manufacturing for

the 6-month period;

• A biomaterials shortage prevents the

continuation of manufacturing for the 6-

month period;

• A liability problem may exist for the

manufacturer if the manufacturing is

continued for the 6-month period;

• Continuation of the manufacturing

for the 6-month period may cause

substantial economic hardship for the

manufacturer;

• The manufacturer has filed for

bankruptcy under chapter 7 or 11 of title

11, United States Code (11 U.S.C. 701 et

seq. and 1101 et seq.); or

• The manufacturer can stop making

the product but still distribute it to

satisfy existing market need for 6

months.

Section 506C(c) of the act requires us

to distribute, to the maximum extent

practicable, information to the public

about the discontinuation of products

described in section 506C(a).

III. Description of the Proposed Rule

A. Notification Requirements

Section 314.81(b)(3)(iii) (21 CFR

314.81(b)(3)(iii)) of our current

regulations requires all applicants to

notify us when they withdraw a drug

product from sale in the United States.

This notification must take place within

15 days of the withdrawal.

As described above, under section

506C(a) of the act, the sole manufacturer

of a drug product that meets the

following three criteria must notify us at

least 6 months before discontinuing

manufacture of the product:

1. The product must be life

supporting, life sustaining, or intended

for use in the prevention of a

debilitating disease or condition;

2. The product must have been

approved under section 505(b) or (j) of

the act; and

3. The product must not have been

originally derived from human tissue

and replaced by a recombinant product.

We are proposing to amend our

postmarketing reporting regulations in

§ 314.81 to implement these new

statutory requirements. Proposed

§ 314.81(b)(3)(iii) would state that

applicants who are sole manufacturers

of these drug products must notify us at

least 6 months before discontinuing

manufacture of the products.

Under this proposal, a life supporting

or life sustaining drug would be a drug

product that is essential to, or that

yields information that is essential to,

the restoration or continuation of a

bodily function important to the

continuation of human life. This

definition of a life sustaining or life

supporting product has been adapted

from our regulations governing medical

devices (21 CFR 860.3(e)). The Center

for Devices and Radiological Health, in

adopting the medical device

interpretation of life sustaining or life

supporting product (43 FR 32988, July

28, 1978), noted its reliance on the

legislative history of the 1976 Medical

Device Amendments to the act (Public

Law 94–295) regarding the definition

and application of the term (H. Rept.

94–1090, Medical Device Amendments,

May 6, 1976 (Committee of Conference),

p. 56).

We interpret the phrase ‘‘debilitating

disease or condition,’’ as stated in

section 506C(a) of the act, to mean

serious disease or condition. The use of

the phrase ‘‘serious disease or

condition’’ is consistent with other

regulations (e.g., Accelerated Approval

of New Drugs and Biological Products

for Serious or Life-Threatening Illnesses

(21 CFR parts 314 subpart H and 601

subpart E) (accelerated approval rule))

and policy statements (e.g., guidance for

industry, ‘‘Fast Track Drug Development

Programs—Designation, Development,

and Application Review’’ (October

1998) (fast track guidance)). As

discussed in the preamble to the

proposed accelerated approval rule (57

FR 13234, April 15, 1992),

determination of the seriousness of a

condition is a matter of judgment, but

generally is based on its impact on such

factors as survival, day-to-day

functioning, or the likelihood that the

disease, if left untreated, will progress

from a less severe condition to a more

serious one. The fast track guidance

elaborates on our current approach to

determining whether a disease or

condition is serious by providing

several examples of situations in which

a drug would be considered to prevent

a serious disease or condition. The fast

track guidance is available at the CDER

and CBER addresses above.

By the terms of the statute, the

requirements of section 506C of the act

are limited to products that we have

approved under the authority of section

505(b) or (j) of the act. To implement

this limitation, products we have

approved under the authority of section

351 of the Public Health Service Act (42

U.S.C. 262) would not be covered by

this proposed regulation.

To implement the last requirement of

section 506C(a) of the act, the proposed

rule specifically excludes from the

notification requirements a

manufacturer whose product was

originally derived from human tissue

and was subsequently replaced by a

recombinant product.

Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules 66667

B. Reduction in the Discontinuance

Notification Period

Under section 506C(b) of the act, we

may reduce the 6-month notification

period if we find good cause for the

reduction, generally as established by

manufacturer certification that good

cause exists for the reduction.

FDA is proposing § 314.91 to

implement section 506C(b) of the act.

Proposed § 314.91 would allow the

agency to reduce for good cause the 6-

month notification period required

under proposed § 314.81(b)(3)(iii)(a).

Under proposed § 314.91(b), we can

reduce the 6-month discontinuance

notification period when we find good

cause exists for the reduction. We may

find good cause exists based on

information certified by an applicant in

a written request for a reduction of the

discontinuance notification period. In

limited circumstances, we also may find

good cause exists based on information

already known to us. These

circumstances can include the

withdrawal of the drug from the market

based upon formal regulatory action

(e.g., under the procedures described 21

CFR 314.150) for the publication of a

notice of opportunity for a hearing

describing the basis for the proposed

withdrawal of a drug from the market)

or resulting from consultations between

the applicant and us. To assist a

manufacturer in requesting a reduction

in the notification period, proposed

§ 314.91(c)(1) provides a template for

certification that good cause exists.

Proposed § 314.91 repeats the

examples in section 506C of the act and

describes the information an applicant

must provide FDA to establish good

cause:

• To certify that a public health

problem may result from continuation

of manufacturing for the 6-month

period, a manufacturer would need to

describe in detail the potential threat to

the public health (proposed

§ 314.91(d)(1)).

• To certify that a biomaterials

shortage prevents the continuation of

manufacturing for the 6-month period,

the manufacturer would need to: (1)

Describe in detail the steps it has taken

to try to secure an adequate supply of

biomaterials to enable manufacturing

during the 6-month period, and (2)

explain why the biomaterials could not

be secured (proposed § 314.91(d)(2)).

• To certify that a liability problem

may exist for the manufacturer if the

manufacturing is continued for the 6-

month period, the manufacturer would

need to explain to the agency in detail

the potential liability problem

(proposed § 314.91(d)(3)).

• To certify that continuation of the

manufacturing for the 6-month period

may cause substantial economic

hardship for the manufacturer, the

manufacturer would need to describe in

detail the financial impact on the

company of manufacturing the drug

product for 6 more months (proposed

§ 314.91(d)(4)).

• To certify that the manufacturer has

filed for bankruptcy under chapter 7 or

11 of title 11, United States Code, the

manufacturer would need to send the

agency documentation of the filing or

proof that the filing occurred (proposed

§ 314.91(d)(5)).

• To certify that the manufacturer can

stop making the product but still

distribute it to satisfy existing market

need for 6 months, the manufacturer

would need to describe in detail its

processes: (1) To determine market need

and (2) to ensure distribution for the 6-

month period (proposed § 314.91(d)(6)).

A manufacturer may also establish

good cause by other circumstances

(proposed § 314.91(d)(7)). To certify that

other circumstances establish good

cause, the manufacturer would need to

fully explain to us the need for a

reduction in the 6-month notification

period.

In assessing a manufacturer’s

assertion that good cause exists to

warrant a reduction in the notification

period, we may consider information in

the certification and other information

already available to us.

C. Disclosure of Discontinuance

Information to the Public

As noted above, section 506C(c) of the

act states that to the maximum extent

practicable, we are to distribute

information to the public about the

discontinuation of products described

in section 506C(a).

To implement section 506C(c) of the

act, we are proposing

§ 314.81(b)(3)(iii)(d). Under this

regulation, we would publicly disclose

a list of the drugs that will be

discontinued under the rule. The listing

of discontinued products would

include:

• The brand and generic name, the

manufacturer, and indication(s) of the

drug product;

• Whether a reduction in the

notification period was granted by the

agency under proposed § 314.91;

• If applicable, the reason(s) for a

notification period of less than 6

months; and

• Any additional information the

agency may have regarding anticipated

product availability.

The proposed rule would require this

information to be distributed through

posting on the Internet and notice in the

Federal Register (proposed

§ 314.81(b)(3)(iii)(c)).

IV. Analysis of Impacts

We have examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612) (as amended by

subtitle D of the Small Business

Regulatory Fairness Act of 1996 (Public

Law 104–121)), and under 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). Under the

Regulatory Flexibility Act, if a rule may

have a significant impact on a

substantial number of small entities, an

agency must consider alternatives that

would minimize the economic impact of

the rule on small entities. Section 202(a)

of the Unfunded Mandates Reform Act

requires agencies to prepare a written

assessment of anticipated costs and

benefits before proposing any rule that

may result in an expenditure by State,

local and tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year (adjusted

annually for inflation).

We believe that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

Executive Order 12866 and in these two

statutes. As shown below, the proposed

rule will result in minimal additional

costs to industry. As a result, the

proposed rule is not significant as

defined by the Executive Order. We

have further determined, as described

below, that the proposed rule would

affect only about one manufacturing

firm per year. Therefore, the agency

certifies that the rule would not have a

significant economic impact on a

substantial number of small entities and

will not require further analysis under

the Regulatory Flexibility Act. The

Unfunded Mandates Reform Act does

not require us to prepare a statement of

costs and benefits for the proposed rule

because the proposed rule in any 1-year

expenditure would not exceed $100

million adjusted for inflation. The

current inflation-adjusted statutory

threshold is $110 million.

The proposed rule would require that

manufacturers of certain drug products

notify the agency at least 6 months

before discontinuing their manufacture.

As explained in section V of this

66668 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules

document, the regulatory conditions

that trigger this requirement occur only

infrequently. Based on agency

experience, we estimate that such

circumstances would occur no more

than once per year. Moreover, the

proposed notification requirement

would impose a significant burden only

when market conditions deteriorate so

quickly that firms could not foresee the

desired action 6 months in advance.

Most pharmaceutical firms rely on

established long-term marketing plans.

For those very few instances where a

manufacturer needs to discontinue

production and could not provide 6-

months notice, the proposed rule

permits us to reduce the notification

period for good cause. Manufacturers

can request a reduced notification

period by submitting a written

certification, based on considerations

such as public health, legal liability,

biomaterial shortage, or substantial

economic hardship. A certification of

substantial economic hardship would

need to demonstrate that the reduced

notification period was necessary to

avoid substantial economic hardship to

the manufacturer.

V. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act

(44 U.S.C. 3501–3520) (the PRA),

Federal agencies must obtain approval

from the Office of Management and

Budget (OMB) for each collection of

information they conduct or sponsor.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information

before submitting the collection to OMB

for approval. To comply with this

requirement, we are publishing notice of

the proposed collection of information

set forth below.

With respect to the following

collection of information, we invite

comment on: (1) Whether the proposed

collection of information is necessary

for the proper performance of our

functions, including whether the

information will have practical utility;

(2) the accuracy of our estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection on respondents,

including through the use of automated

collection techniques, when

appropriate, and other forms of

information technology.

Title: Applications for FDA Approval

to Market a New Drug; Proposed

Revision of Postmarketing Reporting

Requirements

Description: The proposed rule would

implement section 506C of the act and

would require applicants who are the

sole manufacturers of certain drug or

biologic products to notify us at least 6

months before discontinuing the

manufacture of the product. For the rule

to apply, a product would need to meet

the following three criteria:

1. The product must be life

supporting, life sustaining, or intended

for use in the prevention of a

debilitating disease or condition;

2. The product must have been

approved by FDA under section 505(b)

or (j) of the act; and

3. The product must not have been

originally derived from human tissue

and replaced by a recombinant product.

The proposed rule would allow us to

reduce the 6-month notification period

if we find good cause for the reduction.

An applicant would be able to request

that we reduce the notification period

by certifying that good cause for the

reduction exists. Under the proposed

rule, we would also publicly disclose

information about the drugs that are

discontinued under the rule. Existing

regulations, which appear in 21 CFR

part 314, establish postmarketing

reporting requirements for approved

drugs. Current § 314.81(b)(3)(iii) (OMB

Control No. 0910–0001), which would

be renumbered § 314.81(b)(3)(iv) under

the proposed rule, requires an applicant

to notify us within 15 days of

withdrawing a drug product from sale.

This proposed rule would add two new

reporting requirements.

A. Notification of Discontinuance

Under the proposed rule, at least 6

months before an applicant intends to

discontinue manufacture of a product,

the applicant would need to send us

written notification of the

discontinuance. For drugs regulated by

CDER, the applicant would send

notification to the director of the

division in CDER that is responsible for

the application, with one copy to the

CDER Drug Shortage Coordinator and

one copy to CDER’s Drug Listing

Branch. For drugs regulated by CBER,

the applicant would send notification to

the Director of CBER. We would require

that the notification be sent to these

offices to ensure that our efforts

regarding the discontinuation of the

product are commenced in a timely

manner. We intend to work with

members of the industry and with the

applicant during the 6-month

notification period to ease patient

transition from the drug that will be

discontinued to alternate therapy.

B. Certification of Good Cause

We may reduce the 6-month

notification period if we find good cause

for the reduction. As described in

section 506C(b) of the act and proposed

§ 314.91, an applicant would be able to

establish good cause by submitting

written certification to the director of

the division in CDER that is responsible

for the application, with one copy to the

CDER Drug Shortage Coordinator and

one copy to CDER’s Drug Listing Branch

or, for drugs regulated by CBER, to the

Director of CBER, that:

• A public health problem may result

from continuation of manufacturing for

the 6-month period (proposed

§ 314.91(d)(1));

• A biomaterials shortage prevents the

continuation of manufacturing for the 6-

month period (proposed § 314.91(d)(2));

• A liability problem may exist for the

manufacturer if the manufacturing is

continued for the 6-month period

(proposed § 314.91(d)(3));

• Continuation of the manufacturing

for the 6-month period may cause

substantial economic hardship for the

manufacturer (proposed § 314.91(d)(4));

• The manufacturer has filed for

bankruptcy under chapter 7 or 11 of title

11, United States Code (proposed

§ 314.91(d)(5));

• The manufacturer can stop making

the product but still distribute it to

satisfy existing market need for 6

months (proposed § 314.91(d)(6)); or

• Other good cause exists for a

reduction in the notification period

(proposed § 314.91(d)(6)).

With each certification described

above, the applicant would need to

describe in detail the basis for the

applicant’s conclusion that such

circumstances exist. We would require

that the written certification that good

cause exists be submitted to the offices

identified above to ensure that our

efforts regarding the discontinuation

take place in a timely manner.

Description of Respondents: An

applicant who is the sole manufacturer

and who intends to discontinue

marketing of a drug product that: (1) Is

life supporting, life sustaining, or

intended for use in the prevention of a

debilitating disease or condition; (2) was

approved by FDA under section 505(b)

or (j) of the act; and (3) was not

originally derived from human tissue

and replaced by recombinant product.

Burden Estimate: Table 1 of this

document provides an estimate of the

annual reporting burden for notification

of product discontinuance and

certification of good cause under this

proposed rule.

Notification of Discontinuance: Based

on data collected from the CDER drug

Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules 66669

shortage coordinator, CDER review

divisions, and CBER review offices in

fiscal year (FY) 1999, one applicant

discontinued manufacture of one

product meeting the criteria of section

506C of the act. Each applicant meeting

the criteria would be required under

proposed § 314.81(b)(3)(iii) to notify the

agency of the discontinuance at least 6

months before manufacturing ceased.

Although the procedures for notifying

the agency that are set forth in the

proposed rule were not in place in FY

1999, we estimate that the number of

manufacturers who would be required

to notify us of discontinuance would

remain the same. Therefore, the number

of respondents is estimated to be one.

The total annual responses are the total

number of notifications of

discontinuance that are expected to be

submitted to CDER or CBER in a year.

In FY 1999, an applicant would have

been required to notify us of one

product discontinuance under the

proposed procedures. We estimate that

the total annual responses will remain

the same, averaging one response per

respondent. The hours per response is

the estimated number of hours that a

respondent would spend preparing the

information to be submitted with a

notification of product discontinuance,

including the time it takes to gather and

copy the statement. Based on experience

in working with applicants regarding

similar collections of information, we

estimate that approximately 2 hours on

average would be needed per response.

Therefore, we estimate that 2 hours will

be spent per year by respondents

notifying us of a product discontinuance

under these proposed regulations.

Certification of Good Cause: Based on

data collected from the CDER drug

shortage coordinator, CDER review

divisions, and CBER review offices in

FY 1999, one applicant discontinued

manufacture of one product meeting the

criteria of section 506C of the act. Each

applicant would have the opportunity

under proposed § 314.91 to request a

reduction in the 6-month notification

period by certifying to us that good

cause exists for the reduction. We do

not expect that each eligible applicant

will certify that good cause exists for a

reduction. Furthermore, the number of

applicants who would be in a position

to request a reduction is quite small.

Therefore, the number of respondents is

estimated to be one. The total annual

responses are the total number of

notifications of discontinuance that are

expected to be submitted to us in a year.

We estimate that the total annual

responses will remain small, averaging

one response per respondent. The hours

per response is the estimated number of

hours that a respondent would spend

preparing the detailed information

certifying that good cause exists for a

reduction in the notification period,

including the time it takes to gather and

copy the documents. Based on

experience in working with applicants

regarding similar collections of

information, we estimate that

approximately 16 hours on average

would be needed per response.

Therefore, we estimate that 16 hours

will be spent per year by respondents

certifying that good cause exists for a

reduction in the 6-month notification

period under proposed § 314.91.

We invite comments on this analysis

of information collection burdens.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Number of Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

Notification of discontinuance (proposed

§ 314.81(b)(3)(iii)) 1 1 1 2 2

Certification of good cause (proposed § 314.91) 1 1 1 16 16

Total 18

1There are no capital costs or operating and maintenance costs associated with this collection.

In compliance with section 3507(d) of

the PRA (44 U.S.C. 3507(d)), we have

submitted the information collection

provisions of this proposed rule to OMB

for review. Interested persons are

requested to send comments on this

information collection by December 7,

2000, to the Office of Information and

Regulatory Affairs, OMB, New

Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503,

Attn: Desk Officer for FDA.

VI. Federalism

We have analyzed this proposed rule

in accordance with the principles set

forth in Executive Order 13132. We

have determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, we

have concluded that the rule does not

contain policies that have federalism

implications as defined in the order,

and, consequently, a federalism

summary impact statement is not

required.

VII. Environmental Impact

We have 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.

VIII. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal by February 5, 2001. 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 Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

IX. Electronic Access

Copies of the guidance for industry

referred to in this proposed rule are

available on the Internet at http://

www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/cber/

guidelines.htm.

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, the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, it is proposed that 21 CFR

part 314 be amended as follows:

66670 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules

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, 356, 356a, 356b, 356c, 371, 374,

379e.

2. Section 314.81 is amended by

redesignating paragraph (b)(3)(iii) as

(b)(3)(iv); by removing from newly

redesignated paragraph (b)(3)(iv)(c) the

phrase ‘‘(b)(3)(iii)’’ and adding in its

place the phrase ‘‘(b)(3)(iv)’’; and by

adding new paragraph (b)(3)(iii) to read

as follows:

§ 314.81 Other postmarketing reports.

* * * * *

(b) * * *

(3) * * *

(iii) Notification of discontinuance.

(a) An applicant who is the sole

manufacturer of an approved drug

product must notify FDA in writing at

least 6 months prior to discontinuing

manufacture of the drug product if:

(1) The drug product is life

supporting, life sustaining, or intended

for use in the prevention of a serious

disease or condition; and

(2) The drug product was not

originally derived from human tissue

and replaced by a recombinant product.

(b) For drugs regulated by the Center

for Drug Evaluation and Research

(CDER), the notification required by

paragraph (b)(3)(iii)(a) of this section

must be sent to the director of the

division responsible for the application

as identified to the applicant under

§ 314.440(a)(1). The applicant must send

one copy of the notification to the Drug

Shortage Coordinator, at the address of

the Director of CDER, and one copy of

the notification to the Drug Listing

Branch. For drugs regulated by the

Center for Biologics Evaluation and

Research (CBER), the notification

required by paragraph (b)(3)(iii)(a) of

this section must be sent to the Director

of CBER.

(c) FDA will publicly disclose a list of

all drug products to be discontinued

under paragraph (b)(3)(iii)(a) of this

section. If the notification period is

reduced under § 314.91, the list will

state the reason(s) for such reduction

and the anticipated date that

manufacturing will cease.

* * * * *

3. Section 314.91 is added to read as

follows:

§ 314.91 Obtaining a reduction in the

discontinuance notification period.

(a) What is the discontinuance

notification period? The discontinuance

notification period is the 6-month

period required under

§ 314.81(b)(3)(iii)(a). The

discontinuance notification period

begins when an applicant who is the

sole manufacturer of certain products

notifies FDA that it will discontinue

manufacturing the product. The

discontinuance notification period ends

when manufacturing ceases.

(b) When can FDA reduce the

discontinuance notification period?

FDA can reduce the 6-month

discontinuance notification period

when it finds good cause exists for the

reduction. FDA may find good cause

exists based on information certified by

an applicant in a request for a reduction

of the discontinuance notification

period. In limited circumstances, FDA

may find good cause exists based on

information already known to the

agency. These circumstances can

include the withdrawal of the drug from

the market based upon formal FDA

regulatory action (e.g., under the

procedures described in § 314.150 for

the publication of a notice of

opportunity for a hearing describing the

basis for the proposed withdrawal of a

drug from the market) or resulting from

the applicant’s consultations with the

agency.

(c) How can an applicant request a

reduction in the discontinuance

notification period? (1) The applicant

must certify in a written request that, in

its opinion and to the best of its

knowledge, good cause exists for the

reduction. The applicant must submit

the following certification:

The undersigned certifies that good

cause exists for a reduction in the 6-

month notification period required in

§ 314.81(b)(3)(iii)(a) for discontinuing

the manufacture of (name of the drug

product). The following circumstances

establish good cause (one or more of the

circumstances in paragraph (d) of this

section).

(2) The certification must be signed by

the applicant or the applicant’s attorney,

agent (representative), or other

authorized official. If the person signing

the certification does not reside or have

a place of business within the United

States, the certification must contain the

name and address of, and must also be

signed by, an attorney, agent, or other

authorized official who resides or

maintains a place of business within the

United States.

(3) For drugs regulated by the Center

for Drug Evaluation and Research

(CDER), the certification must be

submitted to the director of the division

that is responsible for the application as

identified to the applicant under

§ 314.440(a)(1). One copy of the

certification must be sent to the Drug

Shortage Coordinator, at the address of

the Director of CDER, and one copy of

the certification must be sent to the

Drug Listing Branch. For drugs

regulated by the Center for Biologics

Evaluation and Research (CBER), the

certification must be submitted to the

Director of CBER.

(d) What circumstances and

information can establish good cause

for a reduction in the discontinuance

notification period? (1) A public health

problem may result from continuation

of manufacturing for the 6-month

period. This certification must include a

detailed description of the potential

threat to the public health.

(2) A biomaterials shortage prevents

the continuation of the manufacturing

for the 6-month period. This

certification must include a detailed

description of the steps taken by the

applicant in an attempt to secure an

adequate supply of biomaterials to

enable manufacturing to continue for

the 6-month period and an explanation

of why the biomaterials could not be

secured.

(3) A liability problem may exist for

the manufacturer if the manufacturing is

continued for the 6-month period. This

certification must include a detailed

description of the potential liability

problem.

(4) Continuation of the manufacturing

for the 6-month period may cause

substantial economic hardship for the

manufacturer. This certification must

include a detailed description of the

financial impact of continuing to

manufacture the drug product over the

6-month period.

(5) The manufacturer has filed for

bankruptcy under chapter 7 or 11 of title

11, United States Code (11 U.S.C. 701 et

seq. and 1101 et seq.). This certification

must be accompanied by documentation

of the filing or proof that the filing

occurred.

(6) The manufacturer can continue

distribution of the drug product to

satisfy existing market need for 6

months. This certification must include

a detailed description of the

manufacturer’s processes to ensure such

distribution for the 6-month period.

(7) Other good cause exists for the

reduction. This certification must

include a detailed description of the

need for a reduction.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28519 Filed 11–6–00; 8:45 am]

BILLING CODE 4160–01–F