
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]               
[Page 3611-3614]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja09-86]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0008]

 
Draft Guidance for Industry on Citizen Petitions and Petitions 
for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, 
and Cosmetic Act; 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availability of a draft guidance for industry entitled ``Citizen 
Petitions and Petitions for Stay of Action Subject to Section 505(q) of 
the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug 
Administration Amendments Act of 2007 (FDAAA) added new provisions to 
the Federal Food, Drug, and Cosmetic Act (the act) addressing the 
agency's treatment of certain citizen petitions and petitions for stay 
of agency action (collectively, petitions), as well as related 
applications. The draft guidance describes how FDA will determine if 
the new provisions apply to a particular petition and how FDA will 
determine if a petition would delay approval of a pending abbreviated 
new drug application (ANDA) or 505(b)(2) application. The draft 
guidance also describes how FDA will interpret the requirements that 
such petitions include a certification and that supplemental 
information or comments to such petitions include a verification. The 
draft guidance also addresses the relationship between the review of 
petitions and pending ANDAs and 505(b)(2) applications for which the 
agency has not yet made a decision on approvability.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance, 
including comments regarding the proposed collection of information, by 
March 23, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Nancy Boocker, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Citizen Petitions and Petitions for Stay of Action Subject 
to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' The 
draft guidance provides information regarding FDA's current thinking on 
interpreting section 914 of Title IX of FDAAA (Public Law 110-85). 
Section 914 of FDAAA added new section 505(q) to the act (21 U.S.C. 
355(q)) and governs certain citizen petitions and petitions for stay of 
agency action that request that FDA take any form of action related to 
a pending application submitted under section 505(b)(2) or 505(j) of 
the act. The draft guidance describes FDA's interpretation of section 
505(q) of the act regarding how the agency will determine if: (1) The 
provisions of section 505(q) addressing the treatment of citizen 
petitions and petitions for stay of agency action (collectively, 
petitions) apply to a particular petition and (2) a petition would 
delay approval of a pending ANDA or a 505(b)(2) application. The draft 
guidance also describes how FDA will interpret the provisions of 
section 505(q) requiring that: (1) A petition include a certification 
and (2) supplemental information or comments to a petition include a 
verification. Finally, the draft guidance addresses the relationship 
between the review of petitions and pending ANDAs and 505(b)(2) 
applications for which the agency has not yet made a decision on 
approvability.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on citizen 
petitions and petitions for stay of action that are subject to section 
505(q) of the act. 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. 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. ``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

[[Page 3612]]

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 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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 of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Citizen Petitions and Petitions for Stay of Action Subject 
to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.
    Description of Respondents: Respondents to this collection of 
information as it is related to citizen petitions are individuals or 
households, State or local governments, not-for-profit institutions, 
and businesses or other for-profit institutions or groups. Respondents 
to this collection of information as it is related to petitions for 
stay of agency action are persons who choose to file a petition for an 
administrative stay of action.
    Burden Estimate: FDA is requesting public comment on estimates of 
annual submissions from these respondents, as required by section 
505(q) of the act and described in this draft guidance. Section 
505(q)(1)(H) of the act requires that citizen petitions and petitions 
for stay of agency action that are subject to section 505(q) include a 
certification to be considered for review by FDA. Section 505(q)(1)(I) 
of the act requires that supplemental information or comments to such 
citizen petitions and petitions for stay of agency action include a 
verification to be accepted for review by FDA. The draft guidance 
describes our current thinking on the interpretation of these 
requirements. The draft guidance sets forth the criteria the agency 
will use in determining if the provisions of section 505(q) apply to a 
particular citizen petition or petition for stay of agency action. One 
of the criteria for a citizen petition or petition for stay of agency 
action to be subject to section 505(q) of the act is that a related 
ANDA or 505(b)(2) application is pending at the time the citizen 
petition or petition for stay is submitted. Because petitioners or 
commenters may not be aware of the existence of a pending ANDA or 
505(b)(2) application, the draft guidance recommends that all 
petitioners challenging the approvability of a possible ANDA or 
505(b)(2) application include the certification required in section 
505(q)(1)(H) of the act and that petitioners and commenters submitting 
supplements or comments, respectively, to a citizen petition or 
petition for stay of action challenging the approvability of a possible 
ANDA or 505(b)(2) application include the verification required in 
section 505(q)(1)(I) of the act. The draft guidance also recommends 
that if a petitioner submits a citizen petition or petition for stay of 
agency action that is missing the required certification but is 
otherwise within the scope of section 505(q) of the act and the 
petitioner would like FDA to review the citizen petition or petition 
for stay of agency action, the petitioner should submit a letter 
withdrawing the deficient petition and submit a new petition that 
contains the required certification.
    FDA currently has OMB approval for the collection of information 
entitled, ``General Administrative Procedures: Citizen Petitions; 
Petition for Reconsideration or Stay of Action; Advisory Opinions'' 
(OMB Control Number 0910-0183). This collection of information 
includes, among other things: (1) The format and procedures by which an 
interested person may submit to FDA, in accordance with Sec.  10.20 (21 
CFR 10.20), a citizen petition requesting the Commissioner of Food and 
Drugs (Commissioner) to issue, amend, or revoke a regulation or order, 
or to take or refrain from taking any other form of administrative 
action (Sec.  10.30(b) (21 CFR 10.30(b))); (2) the submission of 
written comments on a filed citizen petition (Sec.  10.30(d)); (3) the 
submission of a supplement or amendment to or a letter to withdraw a 
filed citizen petition (Sec.  10.30(g)); (4) the format and procedures 
by which an interested person may request, in accordance with Sec.  
10.20, the Commissioner to stay the effective date of any 
administrative action (Sec.  10.35(b) (21 CFR 10.35(b))); and (5) the 
submission of written comments on a filed petition for administrative 
stay of action (Sec.  10.35(c)). This information collection includes 
citizen petitions, petitions for administrative stay of action, 
comments to petitions, supplements to citizen petitions, and letters to 
withdraw a citizen petition, as described above, that are subject to 
section 505(q) of the act and described in the draft guidance.
    Under section 505(q) of the act and the draft guidance, the 
following information would be submitted to FDA but is not currently 
approved by OMB under the PRA:
    1. The certification required under section 505(q)(1)(H) of the act 
for citizen petitions that are subject to section 505(q) and/or that 
are challenging the approvability of a possible ANDA or 505(b)(2) 
application. Although the submission of a certification for citizen 
petitions is approved under OMB Control Number 0910-0183, the 
certification would be broadened under section 505(q) of the act and 
the draft guidance.
    2. The certification required under section 505(q)(1)(H) of the act 
for petitions for stay of action that are subject to section 505(q) 
and/or that are challenging the approvability of a possible ANDA or 
505(b)(2) application.
    3. The verification required under section 505(q)(1)(I) of the act 
for comments to citizen petitions.
    4. The verification required under section 505(q)(1)(I) of the act 
for comments to petitions for stay of agency action.
    5. The verification required under section 505(q)(1)(I) of the act 
for supplements to citizen petitions.
    6. Supplements to petitions for stay of agency action and the 
verification required under section 505(q)(1)(I) of the act.
    7. The letter submitted by a petitioner withdrawing a deficient 
petition for stay of agency action that is missing the required 
certification but is otherwise within the scope of section 505(q) of 
the act.
    Section 505(q)(1)(B) and (C) of the act and the draft guidance 
state that if FDA determines that a delay in approval of an ANDA or 
505(b)(2) application is necessary based on a petition subject to 
section 505(q) of the act, the applicant may submit to the petition 
docket clarifications or additional data to allow FDA to review the 
petition promptly. This information collection is not included in this 
analysis because it is approved under OMB Control Number 0910-0001 (21 
CFR 314.54, 314.94, and 314.102).
    Based on FDA's knowledge of citizen petitions and petitions for 
stay of agency action subject to section 505(q) of the act that have 
been submitted since September 27, 2007, as well as the agency's 
familiarity with the time needed to prepare a certification and a

[[Page 3613]]

verification, our estimates for this information collection are as 
follows:
    1. The certification currently submitted for a citizen petition 
would be broadened under section 505(q) of the act and the draft 
guidance. FDA estimates that it will receive annually approximately 25 
certifications under section 505(q)(1)(H) of the act for citizen 
petitions that are subject to section 505(q) and/or that are 
challenging the approvability of a possible ANDA or 505(b)(2) 
application. FDA estimates that approximately 19 respondents will 
submit these certifications and that each certification will take 
approximately 30 minutes to prepare.
    2. FDA estimates that it will receive annually approximately three 
certifications under section 505(q)(1)(H) of the act for petitions for 
stay of action that are subject to section 505(q) and/or that are 
challenging the approvability of a possible ANDA or 505(b)(2) 
application. FDA estimates that approximately three respondents will 
submit these certifications and that each certification will take 
approximately 30 minutes to prepare.
    3. FDA estimates that it will receive annually approximately 12 
verifications required under section 505(q)(1)(I) of the act for 
comments to citizen petitions. FDA estimates that approximately nine 
respondents will submit these verifications, and that each verification 
will take approximately 30 minutes to prepare.
    4. FDA estimates that it will receive annually approximately two 
verifications required under section 505(q)(1)(I) of the act for 
comments to petitions for stay of agency action. FDA estimates that 
approximately two respondents will submit these verifications and that 
each verification will take approximately 30 minutes to prepare.
    5. FDA estimates that it will receive annually approximately 10 
verifications required under section 505(q)(1)(I) of the act for 
supplements to citizen petitions. FDA estimates that approximately 
seven respondents will submit these verifications and that each 
verification will take approximately 30 minutes to prepare.
    6. FDA estimates that it will receive annually approximately one 
supplement to petitions for stay of agency action as described under 
section 505(q)(1)(I) of the act, that approximately one respondent will 
submit this supplement, and that each supplement will take 
approximately 6 hours to prepare. FDA estimates that it will receive 
annually approximately one verification required under section 
505(q)(1)(I) of the act for supplements to petitions for stay of agency 
action, that approximately one respondent will submit this 
verification, and that each verification will take approximately 30 
minutes to prepare.
    7. FDA estimates that it will receive annually approximately one 
letter from petitioners withdrawing a deficient petition for stay of 
agency action that is missing the required certification but is 
otherwise within the scope of section 505(q) of the act. FDA estimates 
that approximately one respondent will submit this letter and that the 
letter will take approximately 30 minutes to prepare.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of        Annual Frequency       Total annual        Hours per
                                                           Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for citizen petitions                                    19                  1.32                 25                0.5               12.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for petitions for stay of agency action                   3                     1                  3                0.5                1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verification for comments to citizen petitions                          9                  1.33                 12                0.5                6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verification for comments to petitions for stay of                      2                     1                  2                0.5                1.0
 agency action
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verification for supplements to citizen petitions                       7                  1.43                 10                0.5                5.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplements to petitions for stay of agency action and                  1                     1                  1                6.5                6.5
 the verification for the supplement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter withdrawing a petition for stay of agency                        1                     1                  1                0.5                0.5
 action
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours                                                                                                                                         33.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 3614]]

    Therefore, the estimated annual reporting burden for this 
information collection is 33 hours.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-937 Filed 1-16-09; 8:45 am]

BILLING CODE 4160-01-S
