Agency Information Collection Activities: Proposed Collection; Comment Request; Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, 2999-3002 [2017-00193]
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Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
grantees have asked about this element
on the current PPR and currently do not
have a place to report that information.
This is information that most grantees
are already collecting. Adding this field
will allow grantees to provide this
information in a consistent format and
allow OCS to more accurately reflect the
total number of jobs created through the
CED program. Since grantees are already
familiar with the current format and
elements, and all questions on the PPR
will remain the same (with one added
question based on grantee feedback),
there will be no additional burden on
grantees.
Respondents: Current CED grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Questionnaire for current OCS—CED grantees ..............................................
170
2
1.50
510
Estimated Total Annual Burden
Hours: 510.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–00202 Filed 1–9–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2009–D–0008]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Citizen Petitions
and Petitions for Stay of Action
Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection in the
guidance on citizen petitions and
petitions for stay of action subject to
section 505(q) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by March 13, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
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written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2009–D–0008 for ‘‘Citizen Petitions and
Petitions for Stay of Action Subject to
Section 505(q) of the Federal Food,
Drug, and Cosmetic Act.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
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Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A12M, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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,
including each proposed extension of an
existing 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
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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.
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,
OMB Control Number 0910–0679—
Extension
FDA’s 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’’ provides information regarding
FDA’s current thinking on interpreting
section 914 of Title IX of the Food and
Drug Administration Amendments Act
(FDAAA) (Pub. L. 110–85). Section 914
of FDAAA added new section 505(q) to
the FD&C 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) (21 U.S.C. 355(b)(2) or 21 U.S.C.
355(j)) of the FD&C Act. The guidance
describes FDA’s interpretation of
section 505(q) of the FD&C 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 abbreviated new drug
application (ANDA) or a 505(b)(2)
application. The guidance also describes
how FDA will interpret the provisions
of section 505(q) requiring that: (1) A
petition includes a certification and (2)
supplemental information or comments
to a petition include a verification.
Finally, the 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.
The Food and Drug Administration
Safety and Innovation Act (FDASIA)
was signed into law on July 9, 2012
(Pub. L. 112–144). Section 1135 of
FDASIA amended section 505(q) of the
FD&C Act in two ways. First, it
shortened FDA’s deadline from 180
days to 150 days for responding to
petitions subject to section 505(q) of the
FD&C Act. Second, it expanded the
scope of section 505(q) of the FD&C Act
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to include certain petitions concerning
applications submitted under section
351(k) of the Public Health Service
(PHS) Act (42 U.S.C. 262), the
abbreviated pathway for the approval of
biosimilar biological products.
Accordingly, we are now including
submissions pertaining to biosimilar
biological product applications in the
information collection burden estimates
in this document.
Section 505(q)(1)(H) of the FD&C 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
FD&C 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
guidance sets forth the criteria the
Agency will use in determining if the
provisions of section 505(q) of the FD&C
Act apply to a particular citizen petition
or petition for stay of Agency action.
The guidance states that one of the
criteria for a citizen petition or petition
for stay of Agency action to be subject
to section 505(q) of the FD&C 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 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 FD&C 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
FD&C Act. The 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
FD&C 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
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number 0910–0191). 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,
supplements to citizen petitions, and
letters to withdraw a citizen petition, as
described previously in this document,
which are subject to section 505(q) of
the FD&C Act and described in the
guidance.
We are requesting OMB approval for
the following collection of information
submitted to FDA under section 505(q)
of the FD&C Act and the guidance:
• The certification required under
section 505(q)(1)(H) of the FD&C Act for
citizen petitions that are subject to
section 505(q) and/or that are
challenging the approvability of a
possible ANDA, 505(b)(2) application,
or biosimilar biological product
application. Although the submission of
a certification for citizen petitions is
approved under OMB control number
0910–0191, the certification would be
broadened under section 505(q) of the
FD&C Act and the guidance.
• The certification required under
section 505(q)(1)(H) of the FD&C Act for
petitions for stay of Agency action that
are subject to section 505(q) and/or that
are challenging the approvability of a
possible ANDA, 505(b)(2) application,
or biosimilar biological product
application.
• The verification required under
section 505(q)(1)(I) of the FD&C Act for
comments to citizen petitions.
• The verification required under
section 505(q)(1)(I) of the FD&C Act for
comments to petitions for stay of
Agency action.
• The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to citizen petitions.
• Supplements to petitions for stay of
Agency action.
3001
• The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to petitions for stay of
Agency action.
• 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
FD&C Act.
Section 505(q)(1)(B) and (C) of the
FD&C Act and the guidance state that if
FDA determines that a delay in approval
of an ANDA, 505(b)(2) application, or
biosimilar biological product
application is necessary based on a
petition subject to section 505(q), 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 currently 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 FD&C Act that have been
submitted to FDA, as well as the
Agency’s familiarity with the time
needed to prepare a supplement, a
certification, and a verification, FDA
estimates the burden of this collection
of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency per
response
Number of
respondents
FD&C Act section
Total annual
responses
Hours per
response
Total hours
Certification for citizen petitions (505(q)(1)(H)) ...........
Certification for petitions for stay of Agency action
(505(q)(1)(H)).
Verification for comments to citizen petitions
(505(q)(1)(I)).
Verification for comments to petitions for stay of
Agency action (505(q)(1)(I)).
Verification for supplements to citizen petitions
(505(q)(1)(I)).
Supplements to petitions for stay of Agency action ....
Verification for supplements to petitions for stay of
Agency action (505(q)(1)(I)).
Letter withdrawing a petition for stay of Agency action.
38
3
1.37
1
52
3
0.5 (30 minutes) .....
0.5 (30 minutes) .....
26
1.5
12
1.66
20
0.5 (30 minutes) .....
10
1
1
1
0.5 (30 minutes) .....
.5
7
2.29
16
0.5 (30 minutes) .....
8
1
1
1
1
1
1
6 .............................
0.5 (30 minutes) .....
6
0.5
3
1
3
0.5 (30 minutes) .....
1.5
Total hours ...........................................................
........................
........................
........................
................................
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00193 Filed 1–9–17; 8:45 am]
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Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2175]
Recommendations for Assessment of
Blood Donor Eligibility, Donor Deferral
and Blood Product Management in
Response to Ebola Virus; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
document entitled ‘‘Recommendations
for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood
Product Management in Response to
Ebola Virus; Guidance for Industry.’’
The guidance document notifies blood
establishments that FDA has determined
Ebola virus to be a transfusiontransmitted infection (TTI) and provides
blood establishments that collect blood
and blood components for transfusion
or further manufacture, including
Source Plasma, with FDA
recommendations for assessing blood
donor eligibility, donor deferral, and
blood product management in the event
that an outbreak of Ebola virus disease
(EVD) with widespread transmission is
declared in at least one country. The
guidance document applies to Ebola
virus (species Zaire ebolavirus). The
recommendations apply to routine
collection of blood and blood
components for transfusion or further
manufacture, including Source Plasma.
The guidance announced in this notice
finalizes the draft guidance of the same
title dated December 2015.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
pmangrum on DSK3GDR082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
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third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–D–2175 for ‘‘Recommendations
for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood
Product Management in Response to
Ebola Virus; Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
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both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Jessica T. Walker, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Recommendations
for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood
Product Management in Response to
Ebola Virus; Guidance for Industry.’’
The guidance document notifies blood
establishments that FDA has determined
Ebola virus to be a TTI under 21 CFR
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]]>Agencies
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 2999-3002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0008]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Citizen Petitions and Petitions for Stay of Action
Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection in
the guidance on citizen petitions and petitions for stay of action
subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by March 13, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2009-D-0008 for ``Citizen Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets
[[Page 3000]]
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A12M, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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, including
each proposed extension of an existing 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.
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, OMB Control Number 0910-0679--Extension
FDA's 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'' provides information regarding FDA's
current thinking on interpreting section 914 of Title IX of the Food
and Drug Administration Amendments Act (FDAAA) (Pub. L. 110-85).
Section 914 of FDAAA added new section 505(q) to the FD&C 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) (21 U.S.C. 355(b)(2) or 21 U.S.C. 355(j)) of the FD&C Act. The
guidance describes FDA's interpretation of section 505(q) of the FD&C
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 abbreviated new drug application (ANDA) or a 505(b)(2)
application. The guidance also describes how FDA will interpret the
provisions of section 505(q) requiring that: (1) A petition includes a
certification and (2) supplemental information or comments to a
petition include a verification. Finally, the 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.
The Food and Drug Administration Safety and Innovation Act (FDASIA)
was signed into law on July 9, 2012 (Pub. L. 112-144). Section 1135 of
FDASIA amended section 505(q) of the FD&C Act in two ways. First, it
shortened FDA's deadline from 180 days to 150 days for responding to
petitions subject to section 505(q) of the FD&C Act. Second, it
expanded the scope of section 505(q) of the FD&C Act to include certain
petitions concerning applications submitted under section 351(k) of the
Public Health Service (PHS) Act (42 U.S.C. 262), the abbreviated
pathway for the approval of biosimilar biological products.
Accordingly, we are now including submissions pertaining to biosimilar
biological product applications in the information collection burden
estimates in this document.
Section 505(q)(1)(H) of the FD&C 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 FD&C 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 guidance sets forth the criteria the Agency will use in
determining if the provisions of section 505(q) of the FD&C Act apply
to a particular citizen petition or petition for stay of Agency action.
The guidance states that one of the criteria for a citizen petition or
petition for stay of Agency action to be subject to section 505(q) of
the FD&C 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 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 FD&C 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 FD&C Act. The 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 FD&C 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
[[Page 3001]]
number 0910-0191). 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 previously in this document, which are subject to section
505(q) of the FD&C Act and described in the guidance.
We are requesting OMB approval for the following collection of
information submitted to FDA under section 505(q) of the FD&C Act and
the guidance:
The certification required under section 505(q)(1)(H) of
the FD&C Act for citizen petitions that are subject to section 505(q)
and/or that are challenging the approvability of a possible ANDA,
505(b)(2) application, or biosimilar biological product application.
Although the submission of a certification for citizen petitions is
approved under OMB control number 0910-0191, the certification would be
broadened under section 505(q) of the FD&C Act and the guidance.
The certification required under section 505(q)(1)(H) of
the FD&C Act for petitions for stay of Agency action that are subject
to section 505(q) and/or that are challenging the approvability of a
possible ANDA, 505(b)(2) application, or biosimilar biological product
application.
The verification required under section 505(q)(1)(I) of
the FD&C Act for comments to citizen petitions.
The verification required under section 505(q)(1)(I) of
the FD&C Act for comments to petitions for stay of Agency action.
The verification required under section 505(q)(1)(I) of
the FD&C Act for supplements to citizen petitions.
Supplements to petitions for stay of Agency action.
The verification required under section 505(q)(1)(I) of
the FD&C Act for supplements to petitions for stay of Agency action.
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 FD&C Act.
Section 505(q)(1)(B) and (C) of the FD&C Act and the guidance state
that if FDA determines that a delay in approval of an ANDA, 505(b)(2)
application, or biosimilar biological product application is necessary
based on a petition subject to section 505(q), 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 currently 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 FD&C Act that
have been submitted to FDA, as well as the Agency's familiarity with
the time needed to prepare a supplement, a certification, and a
verification, FDA estimates the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
FD&C Act section Number of frequency per Total annual Hours per response Total hours
respondents response responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for citizen petitions 38 1.37 52 0.5 (30 minutes)......................... 26
(505(q)(1)(H)).
Certification for petitions for stay of 3 1 3 0.5 (30 minutes)......................... 1.5
Agency action (505(q)(1)(H)).
Verification for comments to citizen 12 1.66 20 0.5 (30 minutes)......................... 10
petitions (505(q)(1)(I)).
Verification for comments to petitions for 1 1 1 0.5 (30 minutes)......................... .5
stay of Agency action (505(q)(1)(I)).
Verification for supplements to citizen 7 2.29 16 0.5 (30 minutes)......................... 8
petitions (505(q)(1)(I)).
Supplements to petitions for stay of Agency 1 1 1 6........................................ 6
action.
Verification for supplements to petitions for 1 1 1 0.5 (30 minutes)......................... 0.5
stay of Agency action (505(q)(1)(I)).
Letter withdrawing a petition for stay of 3 1 3 0.5 (30 minutes)......................... 1.5
Agency action.
----------------------------------------------------------------------------------------------------------
Total hours.............................. .............. .............. .............. ......................................... 54
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00193 Filed 1-9-17; 8:45 am]
BILLING CODE 4164-01-P
