Draft Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Availability, 3611-3614 [E9-937]
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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices
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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder.guidance/
index.htm, https://www.fda.gov/cber/
guidelines.htm or https://
www.regulations.gov.
Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–936 Filed 1–16–09; 8:45 am]
BILLING CODE 4160–01–S
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Draft Guidance for Industry on Citizen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.
mstockstill on PROD1PC66 with NOTICES
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availability of a draft guidance for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 The draft guidance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
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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 The draft guidance also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 https://
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
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Sfmt 4703
3611
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
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21JAN1
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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices
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-forprofit 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
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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
§ 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
(§ 10.30(b) (21 CFR 10.30(b))); (2) the
submission of written comments on a
filed citizen petition (§ 10.30(d)); (3) the
submission of a supplement or
amendment to or a letter to withdraw a
filed citizen petition (§ 10.30(g)); (4) the
format and procedures by which an
interested person may request, in
accordance with § 10.20, the
Commissioner to stay the effective date
of any administrative action (§ 10.35(b)
(21 CFR 10.35(b))); and (5) the
submission of written comments on a
filed petition for administrative stay of
action (§ 10.35(c)). This information
collection includes citizen petitions,
petitions for administrative stay of
action, comments to petitions,
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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
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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.
3613
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 BURDEN1
Number of
Respondents
Annual Frequency
per Response
Total annual
Responses
Hours per
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 agency action
2
1
2
0.5
1.0
Verification for supplements to
citizen petitions
7
1.43
10
0.5
5.0
Supplements to petitions for stay
of agency action and the
verification for the supplement
1
1
1
6.5
6.5
Letter withdrawing a petition for
stay of agency action
1
1
1
0.5
0.5
Total Hours
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1There
33.0
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices
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
https://www.fda.gov/cder/guidance/
index.htm or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0224]
Final Guidance for Sponsors, Industry,
Researchers, Investigators, and Food
and Drug Administration Staff:
Certifications To Accompany Drug,
Biological Product, and Device
Applications/Submissions:
Compliance with Section 402(j) of The
Public Health Service Act, Added By
Title VIII of The Food and Drug
Administration Amendments Act of
2007; Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or agency) is
announcing the availability of a
guidance for industry entitled
‘‘Guidance for Sponsors, Industry,
Researchers, Investigators, and Food
and Drug Administration Staff:
Certifications To Accompany Drug,
Biological Product, and Device
Applications/Submissions: Compliance
with Section 402(j) of The Public Health
Service Act, Added By Title VIII of The
Food and Drug Administration
Amendments Act of 2007’’ dated
January 2009. The guidance provides
sponsors, industry, researchers,
investigators, and FDA staff with the
agency’s current thinking regarding the
types of applications and submissions
that sponsors, industry, researchers, and
investigators submit to FDA and
accompanying certifications as
described in Title VIII of the Food and
Drug Administration Amendments Act
of 2007 (FDAAA).
DATES: Submit written or electronic
comments on agency guidances at any
time.
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18:54 Jan 16, 2009
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Submit written requests for
single copies of the guidance to the
Office of Policy, Office of
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, rm. 4305, Silver Spring,
MD 20993–0002, 301–796–4830. Send
one self addressed adhesive label to
assist that office in processing your
requests. Submit written comments to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane,
rm.1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy, Office
of Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, rm. 4305, Silver Spring,
MD 20993–0002, 301–796–4830.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
Title VIII of FDAAA, Public Law 110–
85, amended the Public Health Service
(PHS) Act by adding new section 402(j),
42 U.S.C. 282(j). The new provisions
require that additional information be
submitted to the clinical trials data bank
(www.ClinicalTrials.gov) previously
established by the National Institutes of
Health (NIH)/National Library of
Medicine (NLM), including expanded
information on clinical trials and
information regarding the results of
clinical trials.
The purpose of Title VIII is to provide
a means for ensuring that the public has
access to information about certain
clinical trials. Specifically, Title VIII is
intended to provide a mechanism for
the public to learn about clinical trials
that are being conducted, as well as the
results of those trials. One provision of
Title VIII (section 401(j)(5)(B) of the PHS
Act, 42 U.S.C. 282(j)(5)(B)) requires that
a certification accompany certain
human drug, biological product, and
device applications and submissions to
FDA.
The certification required under
section 402(j)(5)(B) of the PHS Act (42
U.S.C. 282(j)(5)(B)) plays a role in
helping to achieve the purposes of Title
VIII of FDAAA. One purpose of the
certification is to require the submitter
to confirm that it has complied with all
applicable requirements of Title VIII,
including the requirement to register
applicable clinical trials. ‘‘Applicable
clinical trial’’ is defined at section
402(j)(1)(A)(i) of the PHS Act (42 U.S.C.
282(j)(1)(A)(i)). For additional
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information on this definition and other
relevant definitions, visit the NIH Web
site at https://prsinfo.clinicaltrials.gov.
Failure to submit a certification,
knowingly submitting a false
certification, failure to submit required
clinical trial information, and
submission of clinical trial information
that is false or misleading are all, as
added by Title VIII of FDAAA,
prohibited acts under section 301(jj) of
the Federal Food, Drug, and Cosmetic
Act (the act). Requiring a certification to
accompany certain applications and
submissions submitted to FDA is,
therefore, one way of encouraging
compliance with the provisions of the
law.
The certification also facilitates FDA’s
exercise of its responsibilities under the
law. The certification requirement is
critical to the agency’s ability to
determine whether the law has been
complied with and whether an
enforcement action is appropriate under
any of the prohibited acts under section
301(jj) of the act. Additionally, section
402(j)(3)(F) of the PHS Act (42 U.S.C.
282(j)(3)(F)) requires FDA to notify the
Director of NIH of certain actions taken
on applications and reports that were
accompanied by a certification. That
notification alerts NIH to the fact that
the responsible party must submit the
results of the trials within a certain
period of time, thereby enabling NIH to
exercise its responsibilities under Title
VIII. The information provided in the
certification form also will help FDA
assist NIH in ‘‘linking’’ information
posted on FDA’s Web site regarding
certain FDA regulatory actions to
specific applicable clinical trials
included in the registry and results
databases. This linking, using the
information in the certification form,
particularly the NCT (National Clinical
Trial) number(s) required in the form,
eventually will allow FDA to help the
public more easily correlate various
reports, medical reviews, advisories,
health alerts, advisory committee
actions, and other materials with
specific applicable clinical trials
registered with ClinicalTrials.gov and
identified by the NCT number.
The certification requirement went
into effect on December 26, 2007. To
assist sponsors, industry, researchers,
and investigators in complying with the
requirement, FDA created a certification
form, FDA Form 3674, OMB Control No.
0910–0616, to be used to satisfy the
certification requirement. Since the
provision went into effect, FDA has
received numerous inquiries asking
whether various kinds of information
and documents that sponsors, industry,
researchers, and investigators submit to
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]]>Agencies
[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Notices]
[Pages 3611-3614]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-937]
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/cder/guidance/index.htm or https://
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
