Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 32552-32554 [2014-13037]
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Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
Number of
respondents
Instrument
Grantees ..........................................................................................................
Sub-Grantees (in states with sub-grantee managed systems) .......................
Large Energy Vendors (largest 5 electric, 5 gas, 10 fuel oil, and 10 propane
vendors per state—average) .......................................................................
Small Energy Vendors (excluded except in special circumstances) ...............
Number of
responses per
respondent
51
Average
burden hours
per response
Total burden
hours
1
1
100
80
5,100
16,000
200
1
1
40
10
61,200
2,000
1,981
1
( 2)
84,300
1 200
1 1,530
Total Annual Burden Hours ......................................................................
1 Estimate.
2 Varies.
The following burden estimates
pertain to the grantee survey section of
the form:
ANNUAL BURDEN ESTIMATES FOR LIHEAP PERFORMANCE DATA FORM: PART I—LIHEAP GRANTEE SURVEY
Number of
respondents
Number of
responses per
respondent
Average
hour burden
per response
Total
burden
hours
51
1
3.5
178.50
Grantees ..........................................................................................................
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.
rmajette on DSK2TPTVN1PROD with NOTICES
[FR Doc. 2014–13031 Filed 6–4–14; 8:45 am]
BILLING CODE 4184–01–P
VerDate Mar<15>2010
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0627]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General
Administrative Procedures: Citizen
Petitions; Petition for Reconsideration
or Stay of Action; Advisory Opinions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 7,
2014.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0183. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
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 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,
not-for-profit institutions, or groups.
Section 10.33 (21 CFR 10.33) issued
under section 701(a) of the Federal,
E:\FR\FM\05JNN1.SGM
05JNN1
32553
Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
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 § 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.
In the Federal Register of March 20,
2014 (79 FR 15594), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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
Total annual
responses
Average
burden per
response
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
rmajette on DSK2TPTVN1PROD 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 more
straightforward approach. FDA has
created a single docket on https://
VerDate Mar<15>2010
14:59 Jun 04, 2014
Jkt 232001
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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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
E:\FR\FM\05JNN1.SGM
05JNN1
32554
Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
communication, quicker interaction
between citizen petitioners and FDA,
and easier access to FDA to seek input
through the citizen petition process.
Dated: May 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13037 Filed 6–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0110]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 7,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0686. Also
include the FDA 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
rmajette on DSK2TPTVN1PROD with NOTICES
SUMMARY:
Prescription Drug Advertisements—
(OMB Control Number 0910–0686)—
Extension
Section 502(n) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
VerDate Mar<15>2010
14:59 Jun 04, 2014
Jkt 232001
(21 U.S.C. 352(n)) requires that
manufacturers, packers, and distributors
(sponsors) who advertise prescription
human and animal drugs, including
biological products for humans, disclose
in advertisements certain information
about the advertised product’s uses and
risks. For prescription drugs and
biologics, section 502(n) of the FD&C
Act requires advertisements to contain
‘‘. . . a true statement . . .’’ of certain
information including ‘‘. . . information
in brief summary relating to side effects,
contraindications, and effectiveness
. . .’’ as required by regulations issued
by FDA. FDA’s prescription drug
advertising regulations at § 202.1 (21
CFR 202.1) describe requirements and
standards for print and broadcast
advertisements. Section 202.1 applies to
advertisements published in journals,
magazines, other periodicals, and
newspapers, and advertisements
broadcast through media such as radio,
television, and telephone
communication systems. Print
advertisements must include a brief
summary of each of the risk concepts
from the product’s approved package
labeling (§ 202.1(e)(1)). Advertisements
that are broadcast through media such
as television, radio, or telephone
communications systems must disclose
the major risks from the product’s
package labeling in either the audio or
audio and visual parts of the
presentation (§ 202.1(e)(1)); this
disclosure is known as the ‘‘major
statement’’. If a broadcast advertisement
omits the major statement, or if the
major statement minimizes the risks
associated with the use of the drug, the
advertisement could render the drug
misbranded in violation of section
502(n) of the FD&C Act, section 201(n)
of the FD&C Act (21 U.S.C. 321(n)), and
FDA’s implementing regulations at
§ 202.1(e).
Advertisements subject to the
requirements at § 202.1 are subject to
the Paperwork Reduction Act of 1995
(the PRA) because these advertisements
disclose information to the public. In
addition, § 202.1(e)(6) and (j) include
provisions that are subject to OMB
approval under the PRA.
Reporting to FDA
Section 202.1(e)(6) permits a person
who would be adversely affected by the
enforcement of a provision of
§ 202.1(e)(6) to request a waiver from
FDA for that provision. The waiver
request must set forth clearly and
concisely the petitioner’s interest in the
advertisement, the specific provision of
§ 202.1(e)(6) from which a waiver is
sought, a complete copy of the
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
advertisement, and a showing that the
advertisement is not false, lacking in fair
balance or otherwise misleading, or
otherwise violative of section 502(n) of
the FD&C Act.
Section 202.1(j), which sets forth
requirements for the dissemination of
advertisements subject to the standards
in § 202.1(e), contains the following
information collection that is subject to
the PRA:
Under § 202.1(j)(1), a sponsor must
submit advertisements to FDA for prior
approval before dissemination if: (1)
The sponsor or FDA has received
information that has not been widely
publicized in medical literature that the
use of the drug may cause fatalities or
serious damage; (2) FDA has notified the
sponsor that the information must be
part of the advertisements for the drug;
and (3) the sponsor has failed to present
to FDA a program for assuring that such
information will be publicized promptly
and adequately to the medical
profession in subsequent
advertisements, or if such a program has
been presented to FDA but is not being
followed by the sponsor. Under
§ 202.1(j)(1)(iii), a sponsor must provide
to FDA a program for assuring that
significant new adverse information
about the drug that becomes known (i.e.,
use of drug may cause fatalities or
serious damage) will be publicized
promptly and adequately to the medical
profession in any subsequent
advertisements. Under § 202.1(j)(4), a
sponsor may voluntarily submit
advertisements to FDA for comment
prior to publication.
Disclosures to the Public
Under § 202.1, advertisements for
human and animal prescription drug
and biological products must comply
with the standards described in that
section.
Under § 202.1(j)(1), if information that
the use of a prescription drug may cause
fatalities or serious damage has not been
widely publicized in the medical
literature, a sponsor must include such
information in the advertisements for
that drug.
In the Federal Register of February
27, 2014 (79 FR 11112), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32552-32554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13037]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0627]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General
Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July 7,
2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0183.
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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, not-for-profit institutions, or groups.
Section 10.33 (21 CFR 10.33) issued under section 701(a) of the
Federal,
[[Page 32553]]
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.
In the Federal Register of March 20, 2014 (79 FR 15594), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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........................... 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 more 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
[[Page 32554]]
communication, quicker interaction between citizen petitioners and FDA,
and easier access to FDA to seek input through the citizen petition
process.
Dated: May 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13037 Filed 6-4-14; 8:45 am]
BILLING CODE 4160-01-P
