Proposed Information Collection Activity; Comment Request, 40158-40159 [2017-17935]
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Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of an existing
information collection request; Title of
Information Collection: Cooperative
Agreements to Support Establishment of
State-Operated Health Insurance
Exchanges; Use: All States (including
the 50 States, consortia of States, and
the District of Columbia herein referred
to as States) had the opportunity under
Section 1311(b) of the Affordable Care
to apply for three types of grants: (1)
Planning grants; (2) Early Innovator
grants for early development of
information technology; and (3)
Establishment grants to develop,
implement and start-up Marketplaces.
As of January 1st, 2017, the Secretary
has disbursed over $5.4 billion under
this grant program and, as of that date,
there were 19 active establishment
grants awarded to 12 states. As the
State-Based Marketplaces (SBM) and
Small Business Health Options Program
(SHOP) have matured and moved from
the developmental phases to fulloperation, the reporting requirements
for the states have been modified and
streamlined to insure only information
necessary to provide effective oversight
of their operations by CMS is collected.
Given the innovative nature of
Exchanges and the statutorilyprescribed relationship between the
Secretary and States in their
development and operation, it is critical
that the Secretary work closely with
States to provide necessary guidance
and technical assistance to ensure that
States can meet the prescribed
timelines, federal requirements, and
goals of the statute and the grants
awarded to them. Form Number: CMS–
10371 (OMB Control Number: 0938–
1119); Frequency: Once; Affected
Public: State Government agencies, nonprofit entities; Number of Respondents:
17; Total Annual Responses: 37; Total
Annual Hours: 12,328. (For policy
questions regarding this collection
contact Nickom Sukachevin at (301)
492–4400).
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved information
collection; Title of Information
Collection: State-based Marketplace
Annual Reporting Tool (SMART); Use:
The annual report is the primary vehicle
to insure comprehensive compliance
with all reporting requirements
contained in the Affordable Care Act
(ACA). It is specifically called for in
Section 1313(a)(1) of the Act which
requires an SBM to keep an accurate
accounting of all activities, receipts, and
expenditures, and to submit a report
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15:29 Aug 23, 2017
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annually to the Secretary concerning
such accounting. CMS will use the
information collected from States to
assist in determining if a State is
maintaining a compliant operational
Exchange. Form Number: CMS–10507
(OMB Control Number: 0938–1244);
Frequency: Annually; Affected Public:
State, Local, or Tribal governments;
Number of Respondents: 17; Total
Annual Responses: 17; Total Annual
Hours: 1,173. (For policy questions
regarding this collection contact Christy
Woods at 301–492–5140).
3. Title of Information Collection:
Machine Readable Data for Provider
Network and Prescription Formulary
Content for FFM QHPs; Type of
Information Collection Request:
Extension without change of a currently
approved collection; Use: Under 45 CFR
156.122(d)(1)(2) and 156.230(c) and in
the final rule, Patient Protection and
Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for
2018 (CMS–9934–F), standards for
qualified health plan (QHP) issuers are
established for the submission of
provider and formulary data in a
machine-readable format to the
Department of Health and Human
Services (HHS) and for posting on issuer
Web sites. These standards provide
greater transparency for consumers,
including by allowing software
developers to access formulary and
provider data to create innovative and
informative tools. This Information
Collection Request (ICR) serves as a
formal request for 3-year OMB approval.
On September 30, 2015, the Office of
Management and Budget (OMB) granted
approval to the data collection
Information Collection for Machine
Readable Data for Provider Network and
Prescription Formulary Content for FFM
QHPs.
The burden estimates for the data
collection requirements included in this
package reflect the time and effort for
QHP issuers to update and publish the
appropriate data, and submit it to CMS.
Form Number: CMS–10558 (OMB)
control number: 0938–1284); Frequency:
Annually; Affected Public: Private
Sector, State, Business, and Not-for
Profits; Number of Respondents: 397;
Number of Responses: 397; Total Hours:
208. (For questions regarding this
collection, contact Joshua Annas at
(301) 492–4407).
4. Title of Information Collection:
State Permissions for Enrollment in
Qualified Health Plans in the Federally
Facilitated Exchange & Non-Exchange
Entities; Type of Information Collection
Request: Request for a new OMB control
number; Use: The Patient Protection and
Affordable Care Act, Public Law 111–
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148, enacted on March 23, 2010, and the
Health Care and Education
Reconciliation Act, Public Law 111–
152, enacted on March 30, 2010
(collectively, ‘‘Affordable Care Act’’),
expand access to health insurance for
individuals and employees of small
businesses through the establishment of
new Affordable Insurance Exchanges
(Exchanges), also called Marketplaces,
including the Small Business Health
Options Program (SHOP). The
Exchanges, which became operational
on January 1, 2014, enhance
competition in the health insurance
market, expand access to affordable
health insurance for millions of
Americans, and provide consumers with
a place to easily compare and shop for
health insurance coverage.
This Information Collection Request
(ICR) serves as the formal request for a
new data collection associated with the
HHS Notice of Benefit and Payment
Parameters for 2018 Final Rule (2018
Payment Notice). This ICR includes
information collection requirements
related to the ability of states to permit
agents and brokers to assist qualified
individuals, qualified employers, or
qualified employees enrolling in
Qualified Health Plans in the Federally
Facilitated Exchange (§ 155.220) and
ICRs related to non-exchange entities
(§ 155.260). Form Number: CMS–10650
(OMB control number 0938–NEW);
Frequency: Annually; Affected Public:
Private Sector, State, Business, and Notfor Profits; Number of Respondents:
107,207; Number of Responses: 107,207;
Total Annual Hours: 512,141. (For
questions regarding this collection,
contact Joshua Annas at (301–492–
4407).
Dated: August 18, 2017.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–17918 Filed 8–23–17; 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: Grant Reviewer
Recruitment.
Title: Grant Reviewer Recruitment
Form.
OMB No.: 0970–0455.
Description: The Administration for
Children and Families’ Children’s
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Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices
Bureau (CB) is responsible for
administering the review of eligible
grant applications submitted in
response to funding opportunity
announcements issued by CB. CB
ensures that the objective review
process is independent, efficient,
effective, economical, and complies
with the applicable statutes, regulations,
and policies. Applications are reviewed
by subject experts knowledgeable in
child welfare and related fields. Review
findings are advisory to CB; CB is
responsible for making award decisions.
This announcement is a request for
continued approval of the information
collection system, the Reviewer
Recruitment Module (RRM). CB uses a
web-based data collection form and
database to gather critical reviewer
information in drop down menu format
for data such as: Degree, occupation,
affiliations with organizations and
institutions that serve special
populations, and demographic
information that may be voluntarily
provided by a potential reviewer.
These data elements help CB find and
select expert grant reviewers for
40159
objective review committees. The webbased system permits reviewers to
access and update their information at
will and as needed. The RRM is
accessible by the general public via
https://rrm.grantsolutions.gov/
AgencyPortal/cb.aspx.
Respondents: Generally, our
reviewers are current or retired
professionals with backgrounds in child
welfare and related fields and in some
instances current or former foster care
parents or clients.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Reviewer Recruitment Module .........................................................................
rmajette on DSKBCKNHB2PROD with NOTICES
Instrument
500
1
.25
125
Estimated Total Annual Burden
Hours: 125.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), 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, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
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. 2017–17935 Filed 8–23–17; 8:45 am]
BILLING CODE 4184–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
on the draft guidance by October 23,
2017.
Food and Drug Administration
ADDRESSES:
[Docket No. FDA–2017–D–1956]
Electronic Submissions
Identifying Trading Partners Under the
Drug Supply Chain Security Act; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Identifying Trading Partners Under the
Drug Supply Chain Security Act’’ (draft
trading partner guidance). FDA is
issuing this guidance to assist industry
and State and local governments in
understanding how to categorize the
entities in the drug supply chain in
accordance with the Drug Supply Chain
Security Act (DSCSA). This guidance
explains how to determine when certain
statutory requirements will apply to
entities that may be considered trading
partners in the drug supply chain. FDA
is also soliciting public input specific to
the activities of ‘‘private-label
distributors’’ of drug products and
whether those activities fall within the
definitions under DSCSA of the various
trading partners.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
SUMMARY:
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You may submit comments
as follows:
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
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]]>Agencies
[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)]
[Notices]
[Pages 40158-40159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17935]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects: Grant Reviewer Recruitment.
Title: Grant Reviewer Recruitment Form.
OMB No.: 0970-0455.
Description: The Administration for Children and Families'
Children's
[[Page 40159]]
Bureau (CB) is responsible for administering the review of eligible
grant applications submitted in response to funding opportunity
announcements issued by CB. CB ensures that the objective review
process is independent, efficient, effective, economical, and complies
with the applicable statutes, regulations, and policies. Applications
are reviewed by subject experts knowledgeable in child welfare and
related fields. Review findings are advisory to CB; CB is responsible
for making award decisions.
This announcement is a request for continued approval of the
information collection system, the Reviewer Recruitment Module (RRM).
CB uses a web-based data collection form and database to gather
critical reviewer information in drop down menu format for data such
as: Degree, occupation, affiliations with organizations and
institutions that serve special populations, and demographic
information that may be voluntarily provided by a potential reviewer.
These data elements help CB find and select expert grant reviewers
for objective review committees. The web-based system permits reviewers
to access and update their information at will and as needed. The RRM
is accessible by the general public via https://rrm.grantsolutions.gov/AgencyPortal/cb.aspx.
Respondents: Generally, our reviewers are current or retired
professionals with backgrounds in child welfare and related fields and
in some instances current or former foster care parents or clients.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Reviewer Recruitment Module................. 500 1 .25 125
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 125.
In compliance with the requirements of the Paperwork Reduction Act
of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), 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, 330 C Street SW.,
Washington DC 20201. Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
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. 2017-17935 Filed 8-23-17; 8:45 am]
BILLING CODE 4184-01-P
