[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Notices]
[Pages 71794-71797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33092]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4959]
Draft Guidance for Industry on Disclosing Information Provided to
Advisory Committees in Connection With Open Advisory Committee Meetings
Related to the Testing or Approval of New Drugs and Convened by the
Center for Drug Evaluation and Research, Beginning on January 1, 2000;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Disclosing
Information Provided to Advisory Committees in Connection With Open
Advisory Committee Meetings Related
[[Page 71795]]
to the Testing or Approval of New Drugs and Convened by the Center for
Drug Evaluation and Research, Beginning on January 1, 2000.'' This
document is intended to provide guidance to sponsors of applications
that are the subject of an open advisory committee meeting convened by
the Center for Drug Evaluation and Research (CDER), beginning January
1, 2000. The draft guidance describes procedures that will be adopted
by CDER for making information provided to advisory committee members
in connection with such meetings publicly available. The draft guidance
also describes how a sponsor should prepare its submission to an
advisory committee.
DATES: Submit written comments on the draft guidance document by
February 22, 2000. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of this draft guidance for industry are available on
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit
written requests for single copies of the draft guidance to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist the office in
processing your request. Submit written comments on the draft guidance
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Murray M. Lumpkin, Center for Drug
Evaluation and Research (HFD-2), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5400.
SUPPLEMENTARY INFORMATION:
I. Description of the Guidance
FDA is announcing the availability of a draft guidance for industry
entitled ``Disclosing Information Provided to Advisory Committees in
Connection With Open Advisory Committee Meetings Related to the Testing
or Approval of New Drugs and Convened by the Center for Drug Evaluation
and Research, Beginning on January 1, 2000.'' This draft guidance is
intended to provide guidance to sponsors of applications that are the
subject of an open advisory committee meeting convened by CDER,
beginning January 1, 2000. The draft guidance describes procedures that
will be adopted by CDER for making information that is provided to
advisory committee members in connection with such meetings publicly
available. The draft guidance also describes how a sponsor should
prepare its submission to an advisory committee.
In the Federal Register of November 30, 1999 (64 FR 66920), FDA
announced the availability of a guidance document entitled ``Disclosure
of Materials Provided to Advisory Committees in Connection With Open
Advisory Committee Meetings Convened by the Center for Drug Evaluation
and Research Beginning on January 1, 2000'' (the disclosure policy
guidance). The disclosure policy guidance provided guidance on how FDA
interprets the Federal Advisory Committee Act (the FACA) (5 U.S.C. app.
2) and Sec. 314.430 (21 CFR 314.430) with respect to the disclosure of
materials provided to advisory committees and how FDA will exercise its
discretion under Sec. 314.430(d)(1) in connection with open advisory
committee meetings convened by CDER beginning on January 1, 2000. In
the disclosure policy guidance, FDA stated that the agency construes
the FACA to require that, with respect to any open advisory committee
meeting convened pursuant to the FACA, whenever practicable and subject
to any applicable exemptions of the Freedom of Information Act (the
FOIA) (5 U.S.C. 552), those materials that are provided to the members
of an advisory committee in connection with that meeting must be made
available for public inspection and copying before or at the time of
the advisory committee meeting. The agency also stated in the
disclosure policy guidance that FDA interprets Sec. 314.430 to be
consistent with the FACA and therefore will exercise its discretion
under Sec. 314.430(d)(1) in a manner consistent with the FACA and the
FOIA as described in the previous sentence to make available for public
inspection and copying materials provided to the members of an advisory
committee in connection with open advisory committee meetings convened
by CDER, beginning on January 1, 2000. In the disclosure policy
guidance, FDA stated its intention to provide further guidance on what
sponsors may expect concerning the disclosure of this information.
The draft guidance entitled ``Disclosing Information Provided to
Advisory Committees in Connection With Open Advisory Committee Meetings
Related to the Testing or Approval of New Drugs and Convened by the
Center for Drug Evaluation and Research, Beginning on January 1,
2000,'' that FDA is making available today, is intended to provide the
procedural information referenced in the disclosure policy guidance.
The procedures in this guidance are intended to make the process of
complying with the disclosure requirements of the FACA as efficient as
possible. The procedures address: (1) The content and organization of a
sponsor submission for an advisory committee; (2) the timing of the
sponsor submission to CDER; (3) the process by which CDER will review
and redact the sponsor submission and the related CDER submission; and
(4) the effect this process may have on the time allotted to a review
cycle in which an advisory committee meeting occurs.
This draft guidance is being issued consistent with FDA's good
guidance practices (62 FR 8961, February 27, 1997). The draft guidance
represents the agency's current thinking on the implementation by CDER
of the disclosure provisions of the FACA. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
Interested persons may submit written comments on the draft
guidance to the Dockets Management Branch (address above). 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. The draft guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
II. The Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. 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, FDA is publishing notice of
the proposed collection of information set forth below.
[[Page 71796]]
With respect to the following collection of information, FDA
invites comment on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's 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: Draft Guidance for Industry on Disclosing Information
Provided to Advisory Committees in Connection With Open Advisory
Committee Meetings Related to the Testing or Approval of New Drugs and
Convened by the Center for Drug Evaluation and Research, Beginning on
January 1, 2000.
Description: FDA is issuing a draft guidance on procedures that
will be adopted by CDER for making information that is provided to
advisory committee members in connection with open advisory committee
meetings publicly available. The procedures address: (1) The content
and organization of a sponsor submission for an advisory committee; (2)
the timing of the sponsor submission to CDER; (3) the process by which
CDER will review and redact the sponsor submission and the related CDER
submission; and (4) the effect this process may have on the time
allotted to a review cycle in which an advisory committee meeting
occurs. Under existing regulations in 21 CFR 14.35(a), sponsors
routinely submit information to the agency that will be provided to
advisory committee members in connection with advisory committee
meetings. A sponsor may submit a package that the sponsor states should
be fully disclosed to the public or a package that contains information
the sponsor asserts should be withheld from public disclosure under the
FOIA. This draft guidance describes the submission of information to
the agency that will be provided to the members of an advisory
committee in connection with an open advisory committee meeting related
to the testing or approval of a new drug and convened by CDER,
beginning on January 1, 2000.
FDA construes the FACA to require that, with respect to any open
advisory committee meeting convened pursuant to the FACA, whenever
practicable and subject to any applicable exemptions of the FOIA, those
materials that are provided to the members of a CDER advisory committee
in connection with that meeting must be made available for public
inspection and copying before or at the time of the advisory committee
meeting. Therefore, under the draft guidance, a sponsor may submit two
types of packages of materials for an advisory committee in connection
with an open advisory committee meeting convened by CDER: (1) A package
that the sponsor states should be fully disclosed to the public because
it does not contain information that should be withheld from public
disclosure under an exemption under the FOIA; and (2) a package that
contains information the sponsor asserts should be withheld from public
disclosure under the FOIA and that, therefore, must be reviewed by the
agency's Freedom of Information staff to ensure that the appropriate
information is redacted. The procedures for submitting the two
collections of information are described in the draft guidance.
A. Fully Releasable Submissions
In the guidance, sponsors are strongly encouraged to submit
advisory committee packages that may be publicly disclosed in their
entirety (i.e., that do not contain any information that the sponsor
wishes to assert is exempt from disclosure under the FOIA because it is
trade secret or confidential commercial information, or because it is
information whose disclosure would constitute an unwarranted invasion
of personal privacy, for example, by clearly identifying individual
subjects). Sponsors are also encouraged to submit an electronic version
of the package.
B. Submissions That Contain Material the Sponsor Asserts is Exempt From
Disclosure
A sponsor may believe that it is necessary to include material in
an advisory committee package that it believes is exempt from
disclosure. As described in the guidance, the agency recommends in this
circumstance that the sponsor segregate the material it believes is
exempt from disclosure from the disclosable material, clearly designate
the material that the sponsor believes is exempt from disclosure, and
provide a detailed justification of both why that specific information
is necessary for the advisory committee's consideration and why it is
exempt from disclosure. Sponsors are also encouraged to submit an
electronic version of the package.
1. Description of Respondents
A sponsor of an unapproved new drug application (NDA), NDA
supplement, abbreviated new drug application (ANDA), biological license
application (BLA), or premarket approval application for a device (PMA)
that is the subject of an open advisory committee convened by CDER,
beginning January 1, 2000, to the extent permitted under applicable law
and unless the unapproved BLA or PMA is being discussed at a segregable
portion of a CDER advisory committee meeting (for example, during the
afternoon session) and not in conjunction with an NDA, NDA supplement,
or ANDA.
2. Burden Estimate
Table 1 of this document provides an estimate of the annual
reporting burden for the submission under the guidance of information
to CDER that will be provided to the members of an advisory committee
in connection with an open advisory committee meeting related to the
testing or approval of a new drug and convened by CDER, beginning on
January 1, 2000.
a. Fully releasable submissions. In calendar year 1998, 30
different sponsors (respondents) submitted background information for
open advisory committee meetings regarding the testing or approval of
new drugs. CDER expects that annually, approximately the same total
number of respondents (i.e., 30 respondents) will submit information
for similar open advisory committee meetings. The procedures for
submitting this information that are set forth in the draft guidance
document were not in place in calendar year 1998. However, based on
CDER's experience with the advisory committee process, and given that
the guidance document strongly encourages respondents to submit
advisory committee packages that may be publicly disclosed in their
entirety, CDER estimates that approximately two-thirds of the total
number of respondents (i.e., 20 respondents) will submit packages that
may be disclosed in their entirety. In calendar year 1998, CDER
received a total of 38 submissions from sponsors in connection with
open advisory committee meetings. The agency expects that this number
will remain the same. However, based on CDER's experience with the
advisory committee process and given that the guidance document
strongly encourages respondents to submit advisory committee packages
that may be publicly disclosed in their entirety, CDER estimates that
approximately two-thirds of the submissions it receives (i.e., 25
responses) will be fully releasable, averaging 1.25 responses per
respondent. Therefore, FDA estimates that the total annual responses
(i.e., the
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total number of fully releasable sponsor submissions that will be
provided to advisory committees) will be 25. The hours per response is
the estimated number of hours that a respondent would spend under the
guidance preparing a fully releasable submission in connection with an
open advisory committee meeting, including submitting an electronic
version of the package. Based on FDA experience and information
provided to the agency by the Pharmaceutical Research and Manufacturing
Association (PhRMA), FDA estimates that approximately 700 hours on
average would be needed per response. Therefore, FDA estimates that
17,500 hours will be spent per year under the guidance by respondents
submitting fully releasable information in connection with open
advisory committee meetings.
b. Submissions that contain material the sponsor asserts is exempt
from disclosure. In calendar year 1998, 30 different sponsors
(respondents) submitted background information for open advisory
committee meetings regarding the testing or approval of new drugs. CDER
expects that annually, approximately the same total number of
respondents (i.e., 30 respondents) will submit information for similar
open advisory committee meetings. The procedures for submitting this
information that are set forth in the draft guidance document were not
in place in calendar year 1998. However, based on CDER's experience
with the advisory committee process, and given that the guidance
document strongly encourages respondents to submit advisory committee
packages that may be publicly disclosed in their entirety, CDER
estimates that approximately one-third of the total number of
respondents (i.e., 10 respondents) will submit packages that contain
material that the sponsor asserts is exempt from disclosure. In
calendar year 1998, CDER received a total of 38 submissions from
sponsors in connection with open advisory committee meetings. The
agency expects that this number will remain the same. However, based on
CDER's experience with the advisory committee process, and given that
the guidance document strongly encourages respondents to submit
advisory committee packages that may be publicly disclosed in their
entirety, CDER estimates that approximately one-third of the
submissions it receives (i.e., 13 responses) will contain information
that the sponsor asserts is exempt from disclosure, averaging 1.3
responses per respondent. Therefore, the total annual response (i.e.,
the total number of sponsor submissions that will be provided to
advisory committees and that the sponsors assert is exempt from
disclosure) is estimated to be 1.3. The hours per response is the
estimated number of hours under the guidance that a respondent would
spend preparing a submission that contains information that the
respondent asserts is exempt from disclosure, including the time FDA
expects it will take a sponsor to submit an electronic version of the
package and to work with the agency to redact any information that is
appropriately exempt from disclosure under the FOIA. Based on FDA
experience and information provided to the agency by PhRMA, FDA
estimates that approximately 1,400 hours on average would be needed per
response. Therefore, FDA estimates that under the guidance, 18,200
hours will be spent per year in connection with open advisory committee
meetings by respondents submitting packages that contain information
that the respondents assert is exempt from disclosure. The total
estimated burden hours under the draft guidance are 35,700.
FDA invites comments on this analysis of information collection
burdens.
Table 1.--Estimated Annual Reporting Burden1
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Number of
Submissions No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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Fully releasable submissions 20 1.25 25 700 17,500
Submissions that contain 10 1.3 13 1,400 18,200
material that is claimed to be
exempt from disclosure
Total 30 38 35,700
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)),
the agency has submitted the information collection provisions of this
draft guidance to OMB for review. Interested persons are requested to
send comments on this information collection by February 22, 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.
Dated: December 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-33092 Filed 12-21-99; 8:45 am]
BILLING CODE 4160-01-F