Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing, 7742-7744 [2018-03604]
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures per
respondent
Number of
respondents
Collection activity/21 CFR section
Total annual
disclosures
Average
burden per
disclosure
Total hours
Notification to Recipients—810.15(a)–(c) ........................
Notification to Recipients; Follow-up—810.15(d) ............
Notification of Consignees by Recipients—810.15(e) .....
2
2
10
1
1
1
2
2
10
12
4
1
24
8
10
Total ..........................................................................
..........................
..........................
........................
........................
42
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate has not changed
for information collection related to
section 518(e) of the FD&C Act and part
810 since the last OMB approval.
Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03605 Filed 2–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2029]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Administrative
Practices and Procedures; Formal
Evidentiary Public Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 administrative
practices and procedures; formal
evidentiary public hearing.
DATES: Submit either electronic or
written comments on the collection of
information by April 23, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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Instructions: All submissions received
must include the Docket No. FDA–
2014–N–2029 for ‘‘Administrative
Practices and Procedures; Formal
Evidentiary Public Hearing.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
Electronic Submissions
submitted as ‘‘Confidential
Submit electronic comments in the
Submissions,’’ publicly viewable at
following way:
https://www.regulations.gov or at the
• Federal eRulemaking Portal: https:// Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
www.regulations.gov. Follow the
Friday.
instructions for submitting comments.
Comments submitted electronically,
• Confidential Submissions—To
including attachments, to https://
submit a comment with confidential
www.regulations.gov will be posted to
information that you do not wish to be
the docket unchanged. Because your
made publicly available, submit your
comment will be made public, you are
comments only as a written/paper
solely responsible for ensuring that your submission. You should submit two
comment does not include any
copies total. One copy will include the
confidential information that you or a
information you claim to be confidential
third party may not wish to be posted,
with a heading or cover note that states
such as medical information, your or
‘‘THIS DOCUMENT CONTAINS
anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The
confidential business information, such Agency will review this copy, including
as a manufacturing process. Please note
the claimed confidential information, in
that if you include your name, contact
its consideration of comments. The
information, or other information that
second copy, which will have the
identifies you in the body of your
claimed confidential information
comments, that information will be
redacted/blacked out, will be available
posted on https://www.regulations.gov.
for public viewing and posted on
https://www.regulations.gov. Submit
• If you want to submit a comment
both copies to the Dockets Management
with confidential information that you
Staff. If you do not wish your name and
do not wish to be made available to the
contact information to be made publicly
public, submit the comment as a
available, you can provide this
written/paper submission and in the
information on the cover sheet and not
manner detailed (see ‘‘Written/Paper
in the body of your comments and you
Submissions’’ and ‘‘Instructions’’).
must identify this information as
Written/Paper Submissions
‘‘confidential.’’ Any information marked
Submit written/paper submissions as
as ‘‘confidential’’ will not be disclosed
follows:
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
• Mail/Hand delivery/Courier (for
more information about FDA’s posting
written/paper submissions): Dockets
Management Staff (HFA–305), Food and of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
Drug Administration, 5630 Fishers
the information at: https://www.gpo.gov/
Lane, Rm. 1061, Rockville, MD 20852.
fdsys/pkg/FR-2015-09-18/pdf/2015• For written/paper comments
23389.pdf.
submitted to the Dockets Management
Docket: For access to the docket to
Staff, FDA will post your comment, as
read background documents or the
well as any attachments, except for
electronic and written/paper comments
information submitted, marked and
received, go to https://
identified, as confidential, if submitted
www.regulations.gov and insert the
as detailed in ‘‘Instructions.’’
at the end of April 23, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Administrative Practices and
Procedures (21 CFR 10.30, 10.33, 10.35,
and 10.85); Formal Evidentiary Public
Hearing (21 CFR 12.22 and 12.45)
(OMB Control Number 0910–0191)—
Extension
The Administrative Procedures Act (5
U.S.C. 553(e)) provides that every
Agency shall give an interested person
the right to petition for issuance,
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amendment, or repeal of a rule. Section
10.30 (21 CFR 10.30) sets forth 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 (the
Commissioner) to issue, amend, or
revoke a regulation or order, or to take
or refrain from taking any other form of
administrative action.
The Commissioner may grant or deny
such a petition, in whole or in part, and
may grant such other relief or take other
action as the petition warrants.
Respondents are individuals or
households, State or local governments,
and not-for-profit institutions or groups.
Section 10.33 (21 CFR 10.33), issued
under section 701(a) of the Federal,
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 371(a)), sets forth the
format and procedures by which an
interested person may request
reconsideration of part or all of a
decision of the Commissioner on a
petition submitted under 21 CFR 10.25
(Initiation of administrative
proceedings). A petition for
reconsideration must contain a full
statement in a well-organized format of
the factual and legal grounds upon
which the petition relies. The grounds
must demonstrate that relevant
information and views contained in the
administrative record were not
previously or not adequately considered
by the Commissioner. The respondent
must submit a petition no later than 30
days after the decision involved.
However, the Commissioner may, for
good cause, permit a petition to be filed
after 30 days. An interested person who
wishes to rely on information or views
not included in the administrative
record shall submit them with a new
petition to modify the decision. FDA
uses the information provided in the
request to determine whether to grant
the petition for reconsideration.
Respondents to this collection of
information are individuals of
households, State or local governments,
not-for-profit institutions, and
businesses or other for-profit
institutions who are requesting from the
Commissioner of FDA a reconsideration
of a matter.
Section 10.35 (21 CFR 10.35), issued
under section 701(a) of the FD&C Act,
sets forth 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.
Such a petition must do the following:
(1) Identify the decision involved; (2)
state the action requested, including the
length of time for which a stay is
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7743
requested; and (3) include a statement of
the factual and legal grounds on which
the interested person relies in seeking
the stay. FDA uses the information
provided in the request to determine
whether to grant the petition for stay of
action.
Respondents to this information
collection are interested persons who
choose to file a petition for an
administrative stay of action.
Section 10.85 (21 CFR 10.85), issued
under section 701(a) of the FD&C Act,
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20, an advisory
opinion from the Commissioner on a
matter of general applicability. When
making a request, the petitioner must
provide a concise statement of the
issues and questions on which an
opinion is requested, and a full
statement of the facts and legal points
relevant to the request. Respondents to
this collection of information are
interested persons seeking an advisory
opinion from the Commissioner.
FDA has developed a method for
electronic submission of citizen
petitions. The Agency still allows for
non-electronic submissions; however,
electronic submissions of a citizen
petition to a specific electronic docket
presents a simpler and more
straightforward approach. FDA has
created a single docket on https://
www.regulations.gov, the U.S.
Government’s consolidated docket
website for Federal Agencies, for the
initial electronic submission of all
citizen petitions. The advantage to this
change is that it ensures efficiency and
ease in communication, quicker
interaction between citizen petitioners
and FDA, and easier access to FDA to
seek input through the citizen petition
process.
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
FD&C Act, set forth the instructions for
filing objections and requests for a
hearing on a regulation or order under
§ 12.20(d) (21 CFR 12.20(d)). Objections
and requests must be submitted within
the time specified in § 12.20(e). Each
objection, for which a hearing has been
requested, must be separately numbered
and specify the provision of the
regulation or the proposed order. In
addition, each objection must include a
detailed description and analysis of the
factual information and any other
document, with some exceptions,
supporting the objection. Failure to
include this information constitutes a
waiver of the right to a hearing on that
objection. FDA uses the description and
analysis to determine whether a hearing
request is justified. The description and
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
analysis may be used only for the
purpose of determining whether a
hearing has been justified under 21 CFR
12.24 and does not limit the evidence
that may be presented if a hearing is
granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
Section 12.45 (21 CFR 12.45), issued
under section 701 of the FD&C Act, sets
forth the format and procedures for any
interested person to file a petition to
participate in a formal evidentiary
hearing, either personally or through a
representative. Section 12.45 requires
that any person filing a notice of
participation state their specific interest
in the proceedings, including the
specific issues of fact about which the
person desires to be heard. This section
also requires that the notice include a
statement that the person will present
testimony at the hearing and will
comply with specific requirements in 21
CFR 12.85, or, in the case of a hearing
before a Public Board of Inquiry,
concerning disclosure of data and
information by participants (21 CFR
13.25). In accordance with § 12.45(e) the
presiding officer may omit a
participant’s appearance.
The presiding officer and other
participants will use the collected
information in a hearing to identify
specific interests to be presented. This
preliminary information serves to
expedite the prehearing conference and
commits participation.
The respondents are individuals or
households, State or local governments,
not-for-profit institutions and
businesses, or other for-profit groups
and institutions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses
per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
10.30—Citizen petition .........................................................
10.33—Administrative reconsideration of action .................
10.35—Administrative stay of action ...................................
10.85—Requests for Advisory opinions ..............................
12.22—Filing objections and requests for a hearing on a
regulation or order ............................................................
12.45—Notice of participation ..............................................
220
6
6
4
1
1
1
1
220
6
5
4
24
10
10
16
5,280
60
50
64
5
5
1
1
5
5
20
3
100
15
Total ..............................................................................
........................
........................
........................
........................
5,569
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
Agency records and experience over the
past 3 years. The increase in burden
hours is due to an increase in the
number of respondents under several
provisions.
Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03604 Filed 2–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
daltland on DSKBBV9HB2PROD with NOTICES
Joint Meeting of the Blood Products
Advisory Committee and the
Microbiology Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming joint public advisory
committee meeting of the Blood
SUMMARY:
VerDate Sep<11>2014
20:10 Feb 21, 2018
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FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, sections B&C), Silver Spring,
MD 20993–0002. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
ADDRESSES:
[Docket No. FDA–2018–N–0467]
AGENCY:
Products Advisory Committee and the
Microbiology Devices Panel of the
Medical Devices Advisory Committee.
The Committee will function as a
medical device panel to provide advice
and recommendations to the Agency on
classification of devices. The Committee
will also provide advice and
recommendations to the FDA on
research programs in the Office of Blood
Research and Review. At least one
portion of the meeting will be closed to
the public.
DATES: The meeting will be held on
March 21, 2018, from 8 a.m. to 5:15 p.m.
and March 22, 2018, from 8 a.m. to 5
p.m.
FOR FURTHER INFORMATION CONTACT:
Bryan Emery or Joanne Lipkind,
Division of Scientific Advisors and
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Consultants, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, Bldg. 71, Rm. 6132, at 240–
402–8054, bryan.emery@fda.hhs.gov
and Rm. 6270 at 240–402–8106,
joanne.lipkind@fda.hhs.gov
respectively, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting. For those unable to attend in
person, the meeting will also be
available via webcast. The webcast will
be available at the following link for
both days: https://collaboration.fda.gov/
bpacmdac2018/.
SUPPLEMENTARY INFORMATION:
Agenda: During the morning session
on March 21, 2018, the Joint Committee
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]]>Agencies
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7742-7744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03604]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2029]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Administrative Practices and Procedures; Formal
Evidentiary Public Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 administrative practices and procedures;
formal evidentiary public hearing.
DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-N-2029 for ``Administrative Practices and Procedures; Formal
Evidentiary Public Hearing.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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
[[Page 7743]]
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35,
and 10.85); Formal Evidentiary Public Hearing (21 CFR 12.22 and 12.45)
(OMB Control Number 0910-0191)--Extension
The Administrative Procedures Act (5 U.S.C. 553(e)) provides that
every Agency shall give an interested person the right to petition for
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30)
sets forth 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 (the
Commissioner) to issue, amend, or revoke a regulation or order, or to
take or refrain from taking any other form of administrative action.
The Commissioner may grant or deny such a petition, in whole or in
part, and may grant such other relief or take other action as the
petition warrants. Respondents are individuals or households, State or
local governments, and not-for-profit institutions or groups.
Section 10.33 (21 CFR 10.33), issued under section 701(a) of the
Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)),
sets forth the format and procedures by which an interested person may
request reconsideration of part or all of a decision of the
Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of
administrative proceedings). A petition for reconsideration must
contain a full statement in a well-organized format of the factual and
legal grounds upon which the petition relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner. The respondent must submit a petition no later
than 30 days after the decision involved. However, the Commissioner
may, for good cause, permit a petition to be filed after 30 days. An
interested person who wishes to rely on information or views not
included in the administrative record shall submit them with a new
petition to modify the decision. FDA uses the information provided in
the request to determine whether to grant the petition for
reconsideration. Respondents to this collection of information are
individuals of households, State or local governments, not-for-profit
institutions, and businesses or other for-profit institutions who are
requesting from the Commissioner of FDA a reconsideration of a matter.
Section 10.35 (21 CFR 10.35), issued under section 701(a) of the
FD&C Act, sets forth 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.
Such a petition must do the following: (1) Identify the decision
involved; (2) state the action requested, including the length of time
for which a stay is requested; and (3) include a statement of the
factual and legal grounds on which the interested person relies in
seeking the stay. FDA uses the information provided in the request to
determine whether to grant the petition for stay of action.
Respondents to this information collection are interested persons
who choose to file a petition for an administrative stay of action.
Section 10.85 (21 CFR 10.85), issued under section 701(a) of the
FD&C Act, sets forth the format and procedures by which an interested
person may request, in accordance with Sec. 10.20, an advisory opinion
from the Commissioner on a matter of general applicability. When making
a request, the petitioner must provide a concise statement of the
issues and questions on which an opinion is requested, and a full
statement of the facts and legal points relevant to the request.
Respondents to this collection of information are interested persons
seeking an advisory opinion from the Commissioner.
FDA has developed a method for electronic submission of citizen
petitions. The Agency still allows for non-electronic submissions;
however, electronic submissions of a citizen petition to a specific
electronic docket presents a simpler and more straightforward approach.
FDA has created a single docket on https://www.regulations.gov, the
U.S. Government's consolidated docket website for Federal Agencies, for
the initial electronic submission of all citizen petitions. The
advantage to this change is that it ensures efficiency and ease in
communication, quicker interaction between citizen petitioners and FDA,
and easier access to FDA to seek input through the citizen petition
process.
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of
the FD&C Act, set forth the instructions for filing objections and
requests for a hearing on a regulation or order under Sec. 12.20(d)
(21 CFR 12.20(d)). Objections and requests must be submitted within the
time specified in Sec. 12.20(e). Each objection, for which a hearing
has been requested, must be separately numbered and specify the
provision of the regulation or the proposed order. In addition, each
objection must include a detailed description and analysis of the
factual information and any other document, with some exceptions,
supporting the objection. Failure to include this information
constitutes a waiver of the right to a hearing on that objection. FDA
uses the description and analysis to determine whether a hearing
request is justified. The description and
[[Page 7744]]
analysis may be used only for the purpose of determining whether a
hearing has been justified under 21 CFR 12.24 and does not limit the
evidence that may be presented if a hearing is granted.
Respondents to this information collection are those parties that
may be adversely affected by an order or regulation.
Section 12.45 (21 CFR 12.45), issued under section 701 of the FD&C
Act, sets forth the format and procedures for any interested person to
file a petition to participate in a formal evidentiary hearing, either
personally or through a representative. Section 12.45 requires that any
person filing a notice of participation state their specific interest
in the proceedings, including the specific issues of fact about which
the person desires to be heard. This section also requires that the
notice include a statement that the person will present testimony at
the hearing and will comply with specific requirements in 21 CFR 12.85,
or, in the case of a hearing before a Public Board of Inquiry,
concerning disclosure of data and information by participants (21 CFR
13.25). In accordance with Sec. 12.45(e) the presiding officer may
omit a participant's appearance.
The presiding officer and other participants will use the collected
information in a hearing to identify specific interests to be
presented. This preliminary information serves to expedite the
prehearing conference and commits participation.
The respondents are individuals or households, State or local
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
10.30--Citizen petition......... 220 1 220 24 5,280
10.33--Administrative 6 1 6 10 60
reconsideration of action......
10.35--Administrative stay of 6 1 5 10 50
action.........................
10.85--Requests for Advisory 4 1 4 16 64
opinions.......................
12.22--Filing objections and 5 1 5 20 100
requests for a hearing on a
regulation or order............
12.45--Notice of participation.. 5 1 5 3 15
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Total....................... .............. .............. .............. .............. 5,569
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates for this collection of information are based
on Agency records and experience over the past 3 years. The increase in
burden hours is due to an increase in the number of respondents under
several provisions.
Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03604 Filed 2-21-18; 8:45 am]
BILLING CODE 4164-01-P
