[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]


-----------------------------------------------------------------------

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Draft Guidance for Industry on Disclosing Information Provided to 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Disclosing 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 The draft guidance describes procedures that will be adopted 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 The draft guidance 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DATES: Submit written comments on the draft guidance document by 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ADDRESSES: Copies of this draft guidance for industry are available on 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written requests for single copies of the draft guidance to the Drug 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 Submit written comments on the draft guidance 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

[[Page 71797]]

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
----------------------------------------------------------------------------------------------------------------
                                                     Number of
           Submissions                No. of       Responses per   Total Annual      Hours per      Total Hours
                                    Respondents     Respondent       Responses       Response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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