Proposed Information Collection Activity; Comment Request, 18296-18297 [2014-07237]
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18296
Federal Register / Vol. 79, No. 62 / Tuesday, April 1, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Statement of Organization, Functions,
and Delegations of Authority
This notice amends Part F, Section
F.70 (Order of Succession) of the
Statement of Organization, Functions,
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Centers for Medicare &
Medicaid Service (CMS), 75 FR 71714,
dated November 24, 2010, which is
rescinded and replaced by the
following:
Orders of Succession
1. During any period when the
Administrator, Centers for Medicare &
Medicaid Services (CMS) has died,
resigned, or otherwise becomes unable
to perform the functions and duties in
the Office of the Administrator, CMS,
the following officers, in the Order of
Succession listed below, shall act for
and perform the functions and duties of
the Office of the Administrator, CMS,
until such time as: the Administrator,
CMS, again becomes available; a
permanent successor is appointed by
the President and confirmed by
Congress; or the temporary successor is
otherwise relieved:
a. Principal Deputy Administrator.
b. Deputy Administrator and Director,
Center for Medicare.
c. Deputy Administrator and Director,
Center for Medicaid and CHIP Services.
d. Chief of Staff.
e. Chief Operating Officer.
2. During any period when there is no
eligible officer available or capable of
performing responsibilities in the Office
of the Administrator, CMS, pursuant to
the officers listed in 1.a. through 1.e.
above, the following positions in CMS,
in the Order of Succession listed below,
shall act and perform the functions and
duties inherent in the Emergency
Operations Executive (EOE) in the event
of an emergency situation:
a. Consortium Administrator,
Consortium for Quality Improvement
and Survey & Certification Operations.
b. Consortium Administrator,
Consortium for Financial Management
and Fee For Service Operations.
c. Consortium Administrator,
Consortium for Medicaid and Children’s
Health Operations.
d. Consortium Administrator,
Consortium for Medicare Health Plans
Operations.
The authority to act as the
Administrator, CMS, must be exercised
in accordance with the provisions of the
Federal Vacancies Reform Act of 1998
(‘‘the Vacancies Act’’), 5 U.S.C. Section
3345 et seq. The ‘‘Acting’’ title is
applicable and reserved only in
instances in which the Administrator,
CMS, position is vacant. In accordance
with the Vacancies Act, the Principal
Deputy Administrator is herein
designated as the first assistant for CMS.
During a planned absence, the
Administrator, CMS, may designate an
individual to serve as ‘‘operationally in
charge.’’ If an individual is serving in an
‘‘operationally in charge’’ capacity, he
or she is not eligible for any delegated
authority under these Orders of
Succession unless he or she was
designated as a delegatee by the
Administrator, CMS.
The two Orders of Succession listed
in this notice are limited to the duties
and responsibilities of only the officers
and positions. Number 1 can only be
exercised in order to accomplish the
goals of maintaining the agency’s
essential functions. Number 2 can only
be exercised to restore the agency’s
normal business functions under the
CMS Continuity of Operations Plan.
The EOE is responsible for notifying
the Secretary, HHS and any available
CMS leadership that the EOE has
assumed responsibility.
I, or my successor retain the authority
to change, amend, or re-delegate this
notice.
The two Orders of Succession listed
in this notice remain in effect and will
be revised accordingly as positions or
nomenclature change in CMS.
This notice only applies to periods
when the Administrator, CMS, or his or
her successor are not available to
perform the duties and responsibilities
contained in the two Orders of
Succession.
This notice is effective upon date of
signature.
Dated: March 27, 2014.
Marilyn Tavenner,
Administrator.
[FR Doc. 2014–07241 Filed 3–31–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Voluntary Establishment of
Paternity
OMB No.: 0970–0175
Description: Section 466(a)(5)(C) of
the Social Security Act requires States
to pass laws ensuring a simple civil
process for voluntarily acknowledging
paternity under which the State must
provide that the mother and putative
father must be given notice, orally and
in writing, of the benefits and legal
responsibilities and consequences of
acknowledging paternity. The
information is to be used by hospitals,
birth record agencies, and other entities
participating in the voluntary paternity
establishment program that collect
information from the parents of children
that are born out of wedlock.
Respondents: The parents of children
that are born out of wedlock.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
None ................................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
1,686,980
1
0.17
286,787
Estimated Total Annual Burden
Hours: 286,787.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
VerDate Mar<15>2010
18:25 Mar 31, 2014
Jkt 232001
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@acf.
hhs.gov. All requests should be
identified by the title of the information
collection.
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01APN1
Federal Register / Vol. 79, No. 62 / Tuesday, April 1, 2014 / Notices
The Department specifically requests
comments on: (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–07237 Filed 3–31–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0329]
Guidance for Industry on Fees for
Human Drug Compounding
Outsourcing Facilities Under the
Federal Food, Drug, and Cosmetic Act;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Fees for Human Drug
Compounding Outsourcing Facilities
Under Sections 503B and 744K of the
FD&C Act.’’ The guidance is intended
for entities that compound human drugs
and elect to register as outsourcing
facilities (outsourcing facility) under
section 503B of the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as added
by the Drug Quality and Security Act
(DQSA). Entities that elect to register as
outsourcing facilities must pay certain
fees to be considered outsourcing
facilities. This guidance describes the
annual establishment fee, the
reinspection fee, annual adjustments to
fees required by law, how to submit
payment, the effect of failure to pay fees,
and how to qualify as a small business
to obtain a reduction of the annual
establishment fee.
DATES: Submit either electronic or
written comments on FDA guidances at
any time. Submit either electronic or
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:02 Mar 31, 2014
Jkt 232001
written comments concerning the
collection of information proposed in
the draft guidance by June 2, 2014.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of User Fee Management and
Budget Formulation, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 2163, Silver
Spring, MD 20903. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: M.
Jonathan Gil, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10001 New Hampshire
Ave., Silver Spring, MD 20903, 301–
796–7900.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Fees
for Human Drug Compounding
Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act.’’ On
November 27, 2013, President Obama
signed the DQSA (Pub. L. 113–54) into
law. The DQSA added a new section
503B to the FD&C Act that created a
category of entities called outsourcing
facilities. Outsourcing facilities, as
defined in section 503B(d)(4) of the
FD&C Act, are facilities that meet
certain conditions described in section
503B(a), including, registering with FDA
as an outsourcing facility and paying
associated fees. If the conditions
outlined in section 503B(a) of the FD&C
Act are satisfied, a drug compounded by
or under the direct supervision of a
licensed pharmacist in an outsourcing
facility is exempt from two sections of
the FD&C Act: (1) Section 502(f)(1) (21
U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate
directions for use); and (2) section 505
(21 U.S.C. 355) (concerning the approval
of human drug products under new
drug applications (NDAs) or abbreviated
new drug applications (ANDAs)). Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice for drugs).
This guidance describes in detail the
fee types and amounts an entity must
PO 00000
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Fmt 4703
Sfmt 4703
18297
pay to satisfy the fee requirements of
sections 503B(a)(9) and 744K of the
FD&C Act to be deemed an outsourcing
facility and maintain its status as an
outsourcing facility, the adjustments to
the fees required by law, how to qualify
as a small business to obtain a reduction
of the annual establishment fee, how
and when to submit payment to FDA,
the effect of failure to pay fees, and feerelated dispute resolution.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501–3520). The title,
description, and respondent description
of the information collection are given
under this section with an estimate of
the reporting and recordkeeping burden.
Included in the estimate is the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the collection
of information.
We invite comments on these topics:
(1) Whether the proposed collection of
information is necessary for the proper
performance of FDA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
FDA’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Guidance for Industry on Fees
for Human Drug Compounding
Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act;
Availability.
Description: The draft guidance
pertains to entities that compound
human drugs and elect to register as
outsourcing facilities. These outsourcing
facilities must pay certain fees to FDA.
The draft guidance describes the fee
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Notices]
[Pages 18296-18297]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Voluntary Establishment of Paternity
OMB No.: 0970-0175
Description: Section 466(a)(5)(C) of the Social Security Act
requires States to pass laws ensuring a simple civil process for
voluntarily acknowledging paternity under which the State must provide
that the mother and putative father must be given notice, orally and in
writing, of the benefits and legal responsibilities and consequences of
acknowledging paternity. The information is to be used by hospitals,
birth record agencies, and other entities participating in the
voluntary paternity establishment program that collect information from
the parents of children that are born out of wedlock.
Respondents: The parents of children that are born out of wedlock.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
None........................................ 1,686,980 1 0.17 286,787
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 286,787.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
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. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
[[Page 18297]]
The Department specifically requests comments on: (a) whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-07237 Filed 3-31-14; 8:45 am]
BILLING CODE 4184-01-P
