[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Proposed Rules]
[Pages 66665-66670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28519]


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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.

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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

[[Page 66666]]

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:
    <bullet> A public health problem may result from continuation of 
manufacturing for the 6-month period;
    <bullet> A biomaterials shortage prevents the continuation of 
manufacturing for the 6-month period;
    <bullet> A liability problem may exist for the manufacturer if the 
manufacturing is continued for the 6-month period;
    <bullet> Continuation of the manufacturing for the 6-month period 
may cause substantial economic hardship for the manufacturer;
    <bullet> 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
    <bullet> 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 Sec. 314.81 to implement these new statutory requirements. Proposed 
Sec. 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.

[[Page 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 Sec. 314.91 to implement section 506C(b) of the 
act. Proposed Sec. 314.91 would allow the agency to reduce for good 
cause the 6-month notification period required under proposed 
Sec. 314.81(b)(3)(iii)(a). Under proposed Sec. 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 
Sec. 314.91(c)(1) provides a template for certification that good cause 
exists.
    Proposed Sec. 314.91 repeats the examples in section 506C of the 
act and describes the information an applicant must provide FDA to 
establish good cause:
    <bullet> 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 Sec. 314.91(d)(1)).
    <bullet> 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 Sec. 314.91(d)(2)).
    <bullet> 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 Sec. 314.91(d)(3)).
    <bullet> 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 Sec. 314.91(d)(4)).
    <bullet> 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 Sec. 314.91(d)(5)).
    <bullet> 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 Sec. 314.91(d)(6)).
    A manufacturer may also establish good cause by other circumstances 
(proposed Sec. 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 
Sec. 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:
    <bullet> The brand and generic name, the manufacturer, and 
indication(s) of the drug product;
    <bullet> Whether a reduction in the notification period was granted 
by the agency under proposed Sec. 314.91;
    <bullet> If applicable, the reason(s) for a notification period of 
less than 6 months; and
    <bullet> 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 Sec. 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

[[Page 66668]]

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 Sec. 314.81(b)(3)(iii) (OMB Control No. 0910-
0001), which would be renumbered Sec. 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 Sec. 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:
    <bullet> A public health problem may result from continuation of 
manufacturing for the 6-month period (proposed Sec. 314.91(d)(1));
    <bullet> A biomaterials shortage prevents the continuation of 
manufacturing for the 6-month period (proposed Sec. 314.91(d)(2));
    <bullet> A liability problem may exist for the manufacturer if the 
manufacturing is continued for the 6-month period (proposed 
Sec. 314.91(d)(3));
    <bullet> Continuation of the manufacturing for the 6-month period 
may cause substantial economic hardship for the manufacturer (proposed 
Sec. 314.91(d)(4));
    <bullet> The manufacturer has filed for bankruptcy under chapter 7 
or 11 of title 11, United States Code (proposed Sec. 314.91(d)(5));
    <bullet> The manufacturer can stop making the product but still 
distribute it to satisfy existing market need for 6 months (proposed 
Sec. 314.91(d)(6)); or
    <bullet> Other good cause exists for a reduction in the 
notification period (proposed Sec. 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

[[Page 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 
Sec. 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 Sec. 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 Sec. 314.91.
    We invite comments on this analysis of information collection 
burdens.

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1</SUP>
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section               No. of       Responses per   Total Annual      Hours per      Total Hours
                                    Respondents     Respondent       Responses       Response
----------------------------------------------------------------------------------------------------------------
Notification of discontinuance          1               1               1               2               2
 (proposed Sec.
 314.81(b)(3)(iii))
Certification of good cause             1               1               1              16              16
 (proposed Sec.  314.91)
Total                                                                                                 18
----------------------------------------------------------------------------------------------------------------
\1\There 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:

[[Page 66670]]

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:


Sec. 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 
Sec. 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 Sec. 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:


Sec. 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 
Sec. 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 Sec. 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 Sec. 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 Sec. 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