Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 15594-15596 [2014-06132]
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15594
Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Notices
and guidelines being implemented in
the field to improve health, prevent or
delay type 2 diabetes and reduce
morbidity, mortality, disability and
costs associated with diabetes and its
complications; and (7) provides
evaluation support for division
programs, grants, and policies,
including the design and evaluation of
data collection instruments for
evaluation of programs.
Dated: March 12, 2014.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2014–06019 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Expansion and Capacity Building
Funding: Senior Medicare Patrol
Program Project Grants
Notice of intent to provide
expansion and capacity building
funding to the incumbent Senior
Medicare Patrol (SMP) grantees under
limited competition.
ACTION:
The Administration for
Community Living is announcing the
application deadline and a single case
deviation from maximum competition
for the Senior Medicare Patrol (SMP)
Program project grants. The SMP
program has 54 SMP project grants
which are currently awarded on two
different three-year cycles with 26
awarded in one year and the other 28
awarded the following year. The
purpose of this deviation is to award a
4th year non-competing continuation to
the 26 SMP project grantees with a three
(3) year budget period set to expire May
31, 2014 so that all 54 SMP project
grants can be moved to the same
competitive three (3) year cycle
beginning in FY 2015.
Program Name: Senior Medicare
Patrol.
Award Amount: $4,373,902 ($168,277
per grantee).
Project Period: 6/1/2011 to 5/31/2015.
Award Type: Cooperative Agreement.
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
Statutory Authority: Title IV and Title II
of the Older Americans Act (42 U.S.C. 3032),
as amended by the Older Americans Act
Amendments of 2006 Public Law 109–365
and HIPAA of 1996 (Pub. L. 104–191)
Catalog of Federal Domestic Assistance
(CFDA) Number: 93.048 Discretionary
Projects
DATES:
VerDate Mar<15>2010
14:48 Mar 19, 2014
Jkt 232001
• Application Submission deadline:
April 21, 2014.
• The anticipated budget period start
date is June 1, 2014.
I. Program Description
The Senior Medicare Patrol (SMP)
program is a national program providing
cooperative agreements to grantees in
every state, the District of Columbia,
Puerto Rico, Guam, and the U.S. Virgin
Islands to help Medicare beneficiaries
detect, prevent and report potential
health care fraud, error and abuse. In
doing so, they not only protect
beneficiaries, they also help preserve
the integrity of the Medicare program.
Because this work often requires face-toface contact to be most effective, SMPs
nationwide recruit, train, and manage
over 5,100 volunteers every year to help
in this effort. The focus of the SMP
program is providing beneficiary
education to prevent the fraud before it
ever occurs.
Justification for the Exception to
Competition
Historically, the 54 SMP project
grants have been awarded using two
different three-year cycles with 26
awarded in one year and the other 28
awarded the following year. This was
originally done to alleviate the
administrative burden of awarding 54
new grants at one time. However, the
SMP program has gone through a
number of changes since its inception,
as has the ACL. Given these changes the
split award of the SMP project grants
has become an administrative burden in
itself by necessitating twice the effort to
prepare and award the grants. Moving
the 54 SMP grants to the same grant
cycle will allow the program to move
forward as one instead of two separate
steps as needed with the current split
grant cycle. Failure to move forward
with this deviation would disrupt ACL’s
ability to improve and advance the SMP
program as one cohesive and consistent
program nationally.
II. Eligible Applicants
Incumbent Senior Medicare Patrol
(SMP) grantees with award expiration
dates of 5/31/14.
III. Evaluation Criteria
Information previously provided in
semi-annual reports, as well as
information in the non-competing
extension application will be
considered to determine satisfactory
progress of the grantee project and
ensure that proposed activities are
within the approved scope and budget
of the grant. Areas that will be evaluated
include:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
A. Project Relevance & Current Need
B. Approach
C. Budget
D. Project Impact
E. Organizational Capacity
IV. Application and Submission
Requirments
A. SF 424—Application for Federal
Assistance
B. SF 424A—Budget Information
C. Separate Budget Narrative/
Justification
D. SF 424B—Assurances. Note: Be sure
to complete this form according to
instructions and have it signed and
dated by the authorized representative
(see item 18d of the SF 424).
E. Lobbying Certification
F. Program narrative—no more than 10
pages.
G. Work Plan
H. Grantees will be required to access
the non-competing application kit in
GrantSolutions.gov to submit all
materials for this application.
V. Application Review Information
Applications will be objectively
reviewed by Federal staff utilizing the
criteria listed above in Section III.
VI. Agency Contact
For further information or comments
regarding this program expansion
supplement, contact Rebecca Kinney,
U.S. Department of Health and Human
Services, Administration for
Community Living, Administration on
Aging, Office of Elder Rights, One
Massachusetts Avenue NW.,
Washington, DC 20001; telephone (202)
357–3520; fax (202) 357–3560; email
Rebecca.Kinney@acl.hhs.gov.
Dated: March 14, 2014.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2014–06109 Filed 3–19–14; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0627]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General
Administrative Procedures: Citizen
Petitions; Petition for Reconsideration
or Stay of Action; Advisory Opinions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\20MRN1.SGM
Notice.
20MRN1
Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Notices
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 reporting requirements contained in
existing FDA regulations regarding the
general administrative procedures for a
person to petition the Commissioner of
Food and Drugs (the Commissioner) to
issue, amend, or revoke a rule; to file a
petition for an administrative
reconsideration or an administrative
stay of action; and to request an
advisory opinion from the
Commissioner.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by May 19, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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
ehiers on DSK2VPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
14:48 Mar 19, 2014
Jkt 232001
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.
General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions—(OMB Control
Number 0910–0183)—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 § 10.20 (21 CFR 10.20)
(submission of documents to Division of
Dockets Management), a citizen petition
requesting 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,
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 (the
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
15595
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 (submission
of documents to Division of Dockets
Management), 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 § 10.20 (submission
of documents to Division of Dockets
Management), an advisory opinion from
the Commissioner on a matter of general
applicability. An advisory opinion
represents the formal position of FDA
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 on the
Agency’s formal position for matters of
general applicability.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20MRN1.SGM
20MRN1
15596
Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
10.30
10.33
10.35
10.85
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
....................................................................................
....................................................................................
....................................................................................
....................................................................................
207
4
5
4
1
1
1
1
207
4
5
4
24
10
10
16
4,968
40
50
64
Total ..............................................................................
........................
........................
........................
........................
5,122
ehiers on DSK2VPTVN1PROD with NOTICES
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.
On December 19, 2013, FDA
published a technical amendment (78
FR 76748) announcing that the Agency
is modernizing its administrative
regulations regarding submission of
citizen petitions to explicitly provide for
electronic submission. The current
regulation does not recognize electronic
methods for submitting citizen
petitions; thus, this action will enable
efficiency and ease in the filing of
citizen petitions.
The Agency still allows for nonelectronic submissions, however,
electronic submissions of a citizen
petition to a specific electronic docket
presents a simpler and straightforward
approach. FDA has created a single
docket on https://www.regulations.gov,
the U.S. Government’s consolidated
docket Web site for Federal Agencies,
for the initial electronic submission of
all citizen petitions. The FDA Electronic
Method for Submission of Citizen
Petitions Docket, Docket No. FDA 2013–
S–0610, allows the petitioner to create
an electronic submission through https://
www.regulations.gov and provides an
alternative to the current system of
submission for citizen petitions.
Electronic submissions through
https://www.regulations.gov will provide
the submitter with an immediate record
of the time of submission. FDA’s
Division of Dockets Management (DDM)
(https://www.fda.gov/
RegulatoryInformation/Dockets/
default.htm) will continue to inform the
submitter of formal filing; however,
tracking will be more easily
accomplished through electronic
submission.
DDM will receive the electronically
submitted citizen petition through the
Federal Dockets Management System,
the Agency component of https://
www.regulations.gov. Subsequently,
DDM will review the electronic
submission and when it accepts the
citizen petition for filing, DDM will
assign a docket number to that petition,
VerDate Mar<15>2010
14:48 Mar 19, 2014
Jkt 232001
different from the FDA electronic
submission docket number. This unique
docket number from DDM identifies the
docket for that particular citizen
petition for all future filings and
submissions related only to that citizen
petition. Subsequent submissions
associated with that citizen petition will
refer to the assigned unique docket
number. 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.
Dated: March 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–06132 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Functional Glycomics in
HIV Vaccine Design.
Date: April 10, 2014 (Subset A).
Time: 1:00 p.m. to 5:00 p.m.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3265, 6700B Rockledge Drive, Bethesda, MD
20817 (Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 6700–B
Rockledge Drive, MDS–7616, Bethesda, MD
20892, 301–451–2639, poeky@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Functional Glycomics in
HIV Vaccine Design.
Date: April 17, 2014 (Subset B).
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3265, 6700B Rockledge Drive, Bethesda, MD
20817 (Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 6700–B
Rockledge Drive, MDS–7616, Bethesda, MD
20892, 301–451–2639, poeky@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 14, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–06135 Filed 3–19–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
E:\FR\FM\20MRN1.SGM
20MRN1
]]>Agencies
[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Notices]
[Pages 15594-15596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06132]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0627]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 15595]]
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 reporting requirements
contained in existing FDA regulations regarding the general
administrative procedures for a person to petition the Commissioner of
Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to
file a petition for an administrative reconsideration or an
administrative stay of action; and to request an advisory opinion from
the Commissioner.
DATES: Submit either electronic or written comments on the collection
of information by May 19, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
General Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions--(OMB Control
Number 0910-0183)--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)
(submission of documents to Division of Dockets Management), a citizen
petition requesting 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, 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 (the 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 (submission of
documents to Division of Dockets Management), 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 (submission of
documents to Division of Dockets Management), an advisory opinion from
the Commissioner on a matter of general applicability. An advisory
opinion represents the formal position of FDA 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 on
the Agency's formal position for matters of general applicability.
FDA estimates the burden of this collection of information as
follows:
[[Page 15596]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
10.30........................... 207 1 207 24 4,968
10.33........................... 4 1 4 10 40
10.35........................... 5 1 5 10 50
10.85........................... 4 1 4 16 64
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,122
----------------------------------------------------------------------------------------------------------------
\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.
On December 19, 2013, FDA published a technical amendment (78 FR
76748) announcing that the Agency is modernizing its administrative
regulations regarding submission of citizen petitions to explicitly
provide for electronic submission. The current regulation does not
recognize electronic methods for submitting citizen petitions; thus,
this action will enable efficiency and ease in the filing 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 straightforward approach. FDA has created
a single docket on https://www.regulations.gov, the U.S. Government's
consolidated docket Web site for Federal Agencies, for the initial
electronic submission of all citizen petitions. The FDA Electronic
Method for Submission of Citizen Petitions Docket, Docket No. FDA 2013-
S-0610, allows the petitioner to create an electronic submission
through https://www.regulations.gov and provides an alternative to the
current system of submission for citizen petitions.
Electronic submissions through https://www.regulations.gov will
provide the submitter with an immediate record of the time of
submission. FDA's Division of Dockets Management (DDM) (https://www.fda.gov/RegulatoryInformation/Dockets/default.htm) will continue to
inform the submitter of formal filing; however, tracking will be more
easily accomplished through electronic submission.
DDM will receive the electronically submitted citizen petition
through the Federal Dockets Management System, the Agency component of
https://www.regulations.gov. Subsequently, DDM will review the
electronic submission and when it accepts the citizen petition for
filing, DDM will assign a docket number to that petition, different
from the FDA electronic submission docket number. This unique docket
number from DDM identifies the docket for that particular citizen
petition for all future filings and submissions related only to that
citizen petition. Subsequent submissions associated with that citizen
petition will refer to the assigned unique docket number. 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.
Dated: March 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-06132 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P
