[Federal Register Volume 67, Number 59 (Wednesday, March 27, 2002)]
[Notices]
[Pages 14719-14721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0458]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Guidance for Industry: Fast Track Drug 
Development Programs--Designation, Development, and Application Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
April 26, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry: Fast Track Drug Development Programs--
Designation, Development, and Application Review (OMB Control No. 
0910-0389)--Extension

    Section 112(a) of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) (Public Law 105-115) amended the Federal Food, 
Drug, and Cosmetic Act (the act) by adding section 506 (21 U.S.C. 356). 
The section authorizes FDA to take appropriate action to facilitate the 
development and expedite the review of new drugs, including biological 
products, intended to treat a serious or life-threatening condition and 
that demonstrates a potential to address an unmet medical need. Under 
section 112(b) of FDAMA, FDA issued guidance to industry on fast track 
policies and procedures outlined in section 506 of the act. The 
guidance discusses collections of information that are specified under 
section 506 of the act, other sections of the Public Health Service Act 
(the PHS Act), or implementing regulations. The guidance describes 
three general areas involving collections of information: (1) Fast 
track designation requests, (2) premeeting packages, and (3) requests 
to submit portions of an application. Of these, fast track designation 
requests and

[[Page 14720]]

premeeting packages, in support of receiving a fast track program 
benefit, provide for additional collections of information not covered 
elsewhere in statute or regulation. Information in support of fast 
track designation or fast track program benefits that has previously 
been submitted to the agency, may, in some cases, be incorporated into 
the request by referring to the information rather than resubmitting 
it.
    Under section 506(a)(1) of the act, an applicant who seeks fast 
track designation is required to submit a request to the agency showing 
that the product meets the statutory standard for designation, i.e., 
that: (1) The product is intended for a serious or life-threatening 
condition; and (2) the product has the potential to address an unmet 
medical need. Mostly, the agency expects that information to support a 
designation request will have been gathered under existing provisions 
of the act, the PHS Act, or the implementing regulations. If such 
information has already been submitted to the agency, the information 
may be summarized in the fast track designation request. The guidance 
recommends that a designation request include, where applicable, 
additional information not specified elsewhere by statute or 
regulation. For example, additional information may be needed to show 
that a product has the potential to address an unmet medical need where 
an approved therapy exists for the serious or life-threatening 
condition to be treated. Such information may include clinical data, 
published reports, summaries of data and reports, and a list of 
references. The amount of information and discussion in a designation 
request need not be voluminous, but it should be sufficient to permit a 
reviewer to assess whether the criteria for fast track designation have 
been met.
    After the agency makes a fast track designation, a sponsor or 
applicant may submit a premeeting package which may include additional 
information supporting a request to participate in certain fast track 
programs. As with the request for fast track designation, the agency 
expects that most sponsors or applicants will have gathered such 
information to meet existing requirements under the act, the PHS Act, 
or implementing regulations. These may include descriptions of clinical 
safety and efficacy trials not conducted under an investigational new 
drug application (IND) (i.e., foreign studies), and information to 
support a request for accelerated approval. The discussion of such 
information in a premeeting package may be summarized if it has already 
been previously submitted to FDA under an OMB approved collection of 
information. Consequently, FDA anticipates that the additional 
collection of information attributed solely to the guidance will be 
minimal.
    Under section 506(c) of the act, a sponsor must submit sufficient 
clinical data for the agency to determine, after preliminary 
evaluation, that a fast track product may be effective. Section 506(c) 
of the act also requires that an applicant provide a schedule for the 
submission of information necessary to make the application complete 
before FDA can commence its review. The guidance does not provide for 
any new collection of information regarding the submission of portions 
of an application that is not required under section 506(c) of the act 
or any other provision of the act. All forms referred to in the 
guidance have a current OMB approval: FDA Forms 1571 (OMB Control No. 
0910-0014, expires September 30, 2002); 356h (OMB Control No. 0910-
0338, expires March 31, 2003); and 3397 (OMB Control No. 0910-0297, 
expires February 29, 2004).
    Respondents to this information collection are sponsors and 
applicants who seek fast track designation under section 506 of the 
act. The agency estimates the total annual number of respondents 
submitting requests for fast track designation to the Center for 
Biologics Evaluation and Research (CBER) and the Center for Drug 
Evaluation and Research (CDER) will be approximately 45. To obtain this 
estimate, FDA averaged the number of requests for fast track 
designation received by CBER and CDER in the 3-year period of 1998 to 
2000. For these 3 years, CBER and CDER together received a yearly 
average of 53 requests from 45 respondents. The rate of submissions is 
not expected to change significantly in the next few years. FDA 
estimates that the number of hours needed to prepare a request for fast 
track designation may range between 40 and 80 hours per request, 
depending on the complexity of each request, with an average of 60 
hours per request, as indicated in table 1 of this document. Not all 
requests for fast track designation may meet the statutory standard. Of 
the average 53 requests made per year, the agency granted 33 requests 
for fast track designation. For each of the 33 granted requests, FDA 
estimates that a premeeting package was submitted to the agency. FDA 
estimates that a premeeting package needs more preparation time than 
needed for a designation request because the issues may be more complex 
and the data may need to be more developed. FDA estimates that the 
preparation hours may generally range between 80 and 120 hours, with an 
average of 100 hours per package, as indicated in table 1 of this 
document. The hour burden estimates contained in table 1 of this 
document are for information collections requests in the guidance only 
and do not include burden estimates for statutory requirements 
specifically mandated by the act, the PHS Act, or implementing 
regulations. FDA estimates the burden of this collection of information 
as follows:
    In the Federal Register of October 23, 2001 (66 FR 53612), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions (the October 2001 notice). One letter of comment 
was received in response to the 60-day notice on the information 
collection.
    The comment declared, without any explanation or supporting 
information, that the proposed collection of information was 
unnecessary. The comment also attempted to reserve judgment as to 
whether our estimated information collection burden was accurate. The 
comment seemed to object to fast track drug development programs and 
stated in part that ``for our Congress to even think about letting it 
happen is playing games with the existing laws.''
    FDA disagrees with the comment. Section 506 of the act requires 
sponsors to submit sufficient clinical data for FDA to determine, after 
preliminary evaluation, whether a fast track product may be effective. 
To obtain that clinical data as described in the guidance document, FDA 
must have an approved collection of information. Failure to obtain OMB 
approval for the proposed collection of information would undermine the 
guidance document's value (because FDA might not receive information 
that would help the review or receive unnecessary or confusing 
information) and ultimately undermine the efficiency of the review 
under a fast track drug development program.
    Additionally, the October 2001 notice provided sufficient 
information and opportunity for public comment on the information 
collection burden estimates given in the notice. The comment received 
did not provide any figures or explanations that would cause us to 
change our burden estimates, so FDA has no reason to revise the 
collection burden estimates.
    As for the comment's remarks regarding fast track drug development 
programs and Congress, such matters are outside the scope of this 
notice. We do, however, regard the statute as providing sufficient 
safeguards to

[[Page 14721]]

prevent unsafe or ineffective drugs from reaching the public.

                                                     Table 1.--Estimated Annual Reporting Burden \1\
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                                                                           Annual Frequency    Total Annual
                   21 CFR Section                      No. of Respondents    per Response       Responses         Hours per Response       Total Hours
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Designation request                                                   45          1.18                   53               60                      3,180
Premeeting packages                                                   33          1.00                   33              100                      3,300
  Total                                                                                                                                           6,480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 19, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7375 Filed 3-26-02; 8:45 am]
BILLING CODE 4160-01-S