Agency Information Collection Activities: Proposed Collection; Comment Request, 58354-58355 [2014-23132]
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58354
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
representation of both genders, ethnic
and racial minorities, and persons with
disabilities. Nominees must be U.S.
citizens, and cannot be full-time
employees of the U.S. Government.
Candidates should submit the
following items:
• Current curriculum vitae, including
complete contact information (name,
affiliation, mailing address, telephone
number, email address)
• A letter of recommendation stating
the qualifications of the candidate
Nomination materials must be
postmarked by October 24, 2014, and
sent to: Kim Distel, Office of Infectious
Diseases, Centers for Disease Control
and Prevention, 1600 Clifton Road NE.,
Mailstop D10, Atlanta, Georgia 30333,
telephone (404) 639–2100.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2014–23055 Filed 9–26–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10492]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:44 Sep 26, 2014
Jkt 232001
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments must be received by
November 28, 2014:
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). To be
assured consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development,
Attention: Document Identifier/
OMB Control Number _________,
Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland
21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
DATES:
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES). CMS–10492 Data
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Submission for the Federally-faciliated
Exchange User Fee Adjustment
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Data
Submission for the Federally-facilitated
Exchange User Fee Adjustment; Use:
The final rule ‘‘Coverage of Certain
Preventive Services Under the
Affordable Care Act’’ published by the
Departments of Health and Human
Services (HHS), the Treasury, and Labor
on July 2, 2013 (78 FR 39870), sets forth
regulations regarding coverage for
certain preventive services under
section 2713 of the Public Health
Service Act, as added by the Patient
Protection and Affordable Care Act, as
amended, and incorporated into the
Employee Retirement Income Security
Act of 1974 and the Internal Revenue
Code. Section 2713 of the Public Health
Service Act requires coverage without
cost sharing of certain preventive health
services, including certain contraceptive
services, in non-exempt, nongrandfathered group health plans and
health insurance coverage. The final
rules establish accommodations with
respect to group health plans
established or maintained by eligible
organizations (and group health
insurance coverage offered in
connection with such plans). Eligible
organizations are required to self-certify
that they are eligible for this
accommodation and provide a copy of
such self-certification to their third
party administrators. The final rules
also set forth processes and standards to
fund the payments for the contraceptive
services that are provided for
participants and beneficiaries in selfinsured plans of eligible organizations
E:\FR\FM\29SEN1.SGM
29SEN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
under the accommodation described
previously, through an adjustment in
the Federally-facilitated Exchange (FFE)
user fee payable by an issuer
participating in an FFE.
In order to facilitate the FFE user fee
adjustment, and ensure that these user
fee adjustments reflect payments for
contraceptive services provided under
this accommodation and that the
adjustment is applied to the appropriate
participating issuer in an FFE, the final
rule requires an information collection
from applicable participating issuers
and third party administrators. In
particular, the final regulations at 45
CFR 156.50(d)(2)(i) provide that a
participating issuer who seeks an FFE
user fee adjustment must submit to HHS
in the year following the benefit year in
which payments for contraceptive
services were made under the
previously mentioned accommodation,
identifying information for the
participating issuer, each third party
administrator, and each self-insured
group health plan, as well as the total
dollar amount of the payments for
contraceptive services that were
provided during the applicable calendar
year under the accommodation. The
final regulation at 45 CFR
156.50(d)(2)(iii) also requires the third
party administrator to submit to HHS
identifying information for the third
party administrator, the participating
issuer, and each self-insured group
health plan, as well as the total number
of participants and beneficiaries in each
self-insured group health plan during
the applicable calendar year, the total
dollar amount of payments made for
contraceptive services, and an
attestation that the payments for
contraceptive services were made in
compliance with 26 CFR 54.9815–
2713A(b)(2) or 29 CFR 2590.715–
2713A(b)(2).
Furthermore, to determine the
potential number of submissions
provided by third party administrators
and allow HHS to prepare to receive
submissions in calendar year 2015, the
final regulation at 45 CFR
156.50(d)(2)(ii) requires third party
administrators to submit to HHS a
notification that the third party
administrator intends for a participating
issuer to seek an FFE user fee
adjustment, by the later of January 1,
2014, or the 60th calendar day following
the date on which the third party
administrator receives a copy of a selfcertification from an eligible
organization. Additionally, a health
insurance issuer providing payments for
contraceptive services for participants
and beneficiaries in insured plans (or
student enrollees and covered
VerDate Sep<11>2014
16:44 Sep 26, 2014
Jkt 232001
dependents in student health insurance
coverage) of eligible organizations to
provide a written notice to such plan
participants and beneficiaries (or such
student enrollees and covered
dependents) informing them of the
availability of such payments.
The burden associated with these
processes includes the time for
applicable participating issuers and
third party administrators to submit
identifying information and total
payments made for contraceptive
services in the prior calendar year, and
for third party administrators to notify
HHS of their intent to seek the user fee
adjustment. HHS estimates 488 third
party administrators, 48 QHP issuers,
and 325 fully insured issuers of eligible
organizations will submit this
information. HHS anticipates that
participating issuers in an FFE seeking
a user fee adjustment and third party
administrators with respect to which the
FFE user fee adjustment is received will
submit this information electronically.
Form Number: CMS–10492 (OMB
Control Number: 0938–NEW);
Frequency: Once, Yearly. Affected
Public: Private Sector—Business or
other for-profits and Not-for-profit
institutions; Number of Respondents:
861; Total Annual Responses: 861 Total
Annual Hours: 12,930. (For policy
questions regarding this collection
contact Jaya Ghildiyal at (301) 492–
5149.)
Dated: September 24, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–23132 Filed 9–26–14; 8:45 am]
BILLING CODE 4120–01–U–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1409]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
58355
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
adverse event reporting by FDA on new
animal drugs and product/
manufacturing defects collected on
paper forms.
DATES: Submit either electronic or
written comments on the collection of
information by November 28, 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
E:\FR\FM\29SEN1.SGM
29SEN1
Agencies
[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Pages 58354-58355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23132]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10492]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. 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 or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments must be received by November 28, 2014:
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address:
CMS, Office of Strategic Operations and Regulatory Affairs, Division of
Regulations Development, Attention: Document Identifier/OMB Control
Number
, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES). CMS-10492 Data Submission for the Federally-
faciliated Exchange User Fee Adjustment
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. The term
``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 requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: Data
Submission for the Federally-facilitated Exchange User Fee Adjustment;
Use: The final rule ``Coverage of Certain Preventive Services Under the
Affordable Care Act'' published by the Departments of Health and Human
Services (HHS), the Treasury, and Labor on July 2, 2013 (78 FR 39870),
sets forth regulations regarding coverage for certain preventive
services under section 2713 of the Public Health Service Act, as added
by the Patient Protection and Affordable Care Act, as amended, and
incorporated into the Employee Retirement Income Security Act of 1974
and the Internal Revenue Code. Section 2713 of the Public Health
Service Act requires coverage without cost sharing of certain
preventive health services, including certain contraceptive services,
in non-exempt, non-grandfathered group health plans and health
insurance coverage. The final rules establish accommodations with
respect to group health plans established or maintained by eligible
organizations (and group health insurance coverage offered in
connection with such plans). Eligible organizations are required to
self-certify that they are eligible for this accommodation and provide
a copy of such self-certification to their third party administrators.
The final rules also set forth processes and standards to fund the
payments for the contraceptive services that are provided for
participants and beneficiaries in self-insured plans of eligible
organizations
[[Page 58355]]
under the accommodation described previously, through an adjustment in
the Federally-facilitated Exchange (FFE) user fee payable by an issuer
participating in an FFE.
In order to facilitate the FFE user fee adjustment, and ensure that
these user fee adjustments reflect payments for contraceptive services
provided under this accommodation and that the adjustment is applied to
the appropriate participating issuer in an FFE, the final rule requires
an information collection from applicable participating issuers and
third party administrators. In particular, the final regulations at 45
CFR 156.50(d)(2)(i) provide that a participating issuer who seeks an
FFE user fee adjustment must submit to HHS in the year following the
benefit year in which payments for contraceptive services were made
under the previously mentioned accommodation, identifying information
for the participating issuer, each third party administrator, and each
self-insured group health plan, as well as the total dollar amount of
the payments for contraceptive services that were provided during the
applicable calendar year under the accommodation. The final regulation
at 45 CFR 156.50(d)(2)(iii) also requires the third party administrator
to submit to HHS identifying information for the third party
administrator, the participating issuer, and each self-insured group
health plan, as well as the total number of participants and
beneficiaries in each self-insured group health plan during the
applicable calendar year, the total dollar amount of payments made for
contraceptive services, and an attestation that the payments for
contraceptive services were made in compliance with 26 CFR 54.9815-
2713A(b)(2) or 29 CFR 2590.715-2713A(b)(2).
Furthermore, to determine the potential number of submissions
provided by third party administrators and allow HHS to prepare to
receive submissions in calendar year 2015, the final regulation at 45
CFR 156.50(d)(2)(ii) requires third party administrators to submit to
HHS a notification that the third party administrator intends for a
participating issuer to seek an FFE user fee adjustment, by the later
of January 1, 2014, or the 60th calendar day following the date on
which the third party administrator receives a copy of a self-
certification from an eligible organization. Additionally, a health
insurance issuer providing payments for contraceptive services for
participants and beneficiaries in insured plans (or student enrollees
and covered dependents in student health insurance coverage) of
eligible organizations to provide a written notice to such plan
participants and beneficiaries (or such student enrollees and covered
dependents) informing them of the availability of such payments.
The burden associated with these processes includes the time for
applicable participating issuers and third party administrators to
submit identifying information and total payments made for
contraceptive services in the prior calendar year, and for third party
administrators to notify HHS of their intent to seek the user fee
adjustment. HHS estimates 488 third party administrators, 48 QHP
issuers, and 325 fully insured issuers of eligible organizations will
submit this information. HHS anticipates that participating issuers in
an FFE seeking a user fee adjustment and third party administrators
with respect to which the FFE user fee adjustment is received will
submit this information electronically. Form Number: CMS-10492 (OMB
Control Number: 0938-NEW); Frequency: Once, Yearly. Affected Public:
Private Sector--Business or other for-profits and Not-for-profit
institutions; Number of Respondents: 861; Total Annual Responses: 861
Total Annual Hours: 12,930. (For policy questions regarding this
collection contact Jaya Ghildiyal at (301) 492-5149.)
Dated: September 24, 2014.
Martique Jones,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2014-23132 Filed 9-26-14; 8:45 am]
BILLING CODE 4120-01-U-P