Agency Information Collection Activities: Proposed Collection: Public Comment Request, 40320-40322 [2016-14656]
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Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
Regulations Restricting the Sale and
Distribution of Cigarettes and
Smokeless Tobacco To Protect Children
and Adolescents OMB Control Number
0910–0312—Extension
This is a request for an extension of
OMB approval for the information
collection requirements contained in
FDA’s regulations for cigarettes and
smokeless tobacco containing nicotine.
The regulations that are codified at 21
§ 1140.30 .............................
CFR part 1140 are authorized by section
102 of the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31). Section
102 of the Tobacco Control Act required
FDA to publish a final rule regarding
cigarettes and smokeless tobacco
identical in its provisions to the
regulation issued by FDA in 1996 (61 FR
44396, August 28, 1996), with certain
specified exceptions including that
subpart C (which included 21 CFR
Reporting ............................
In the Federal Register of January 12,
2016 (81 FR 1428), FDA published a 60day notice requesting public comment
897.24) and 897.32(c) be removed from
the reissued rule (section 102(a)(2)(B)).
The reissued final rule was published in
the Federal Register of March 19, 2010
(75 FR 13225).
This collection includes reporting
information requirements for § 1140.30
which directs persons to notify FDA if
they intend to use a form of advertising
that is not addressed in the regulations.
The requirements are as follows:
Directs persons to notify FDA if they intend to use a form of advertising that is not
originally described in the March 19, 2010, final rule.
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
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1140.30—Scope of Permissible Forms of Labeling and
Advertising ........................................................................
300
1
300
1
300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The burden hour estimates for this
collection of information were based on
industry-prepared data and information
regarding cigarette and smokeless
tobacco product advertising
expenditures.
Section 1140.30 requires
manufacturers, distributors, and
retailers: (1) To observe certain format
and content requirements for labeling
and advertising and (2) to notify FDA if
they intend to use an advertising
medium that is not listed in the
regulations. The concept of permitted
advertising in § 1140.30 is sufficiently
broad to encompass most forms of
advertising. FDA estimates that
approximately 300 respondents will
submit an annual notice of alternative
advertising, and the Agency has
estimated it should take 1 hour to
provide such notice. Therefore, FDA
estimates that the total time required for
this collection of information is 300
hours.
Dated: June 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–14628 Filed 6–20–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:37 Jun 20, 2016
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
SUMMARY:
Comments on this ICR must be
received no later than August 22, 2016.
DATES:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, 5600 Fishers
Lane, Rockville, MD 20857.
ADDRESSES:
Jkt 238001
PO 00000
Frm 00062
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To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Children’s Hospitals Graduate Medical
Education Payment Program
Application and Full-Time Equivalent
Resident Assessment Forms OMB No.
0915–0247 Revision.
Abstract: The Children’s Hospitals
Graduate Medical Education (CHGME)
Payment Program was enacted by Public
Law 106–129, and reauthorized by the
CHGME Support Reauthorization Act of
2013 (Pub. L. 113–98) to provide
Federal support for graduate medical
education (GME) to freestanding
children’s hospitals. The legislation
indicates that eligible children’s
hospitals will receive payments for both
direct and indirect medical education.
The CHGME Payment Program
application and full-time equivalent
(FTE) resident assessment forms
received OMB clearance on June 30,
2014.
The CHGME Support Reauthorization
Act of 2013 included a provision to
FOR FURTHER INFORMATION CONTACT:
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40321
Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
allow certain newly qualified children’s
hospitals to apply for CHGME Payment
Program funding. The CHGME Payment
Program application forms have been
revised to accommodate the new statute.
In addition, a payment question
included in the CHGME Payment
Program application forms has been
removed, since the participating
children’s hospitals are now required to
electronically communicate their
financial information to the Payment
Management System through the
Electronic Handbook.
The form changes are only applicable
to the HRSA 99–1 (also known as
Exhibit O (2)) and the HRSA 99–5. All
other hospital and auditor forms are the
same as currently approved. The
changes to the HRSA 99–1 and HRSA
99–5 forms require OMB approval and
are as follows:
1. HRSA 99–1: Add additional
description to Line 4.06 (both Page 2
and Page 2 Supplemental), 5.06 and
6.06. The current description is, ‘‘FTE
adjusted cap.’’ The new description will
be, ‘‘FTE adjusted cap or 2013 CHGME
Reauthorization cap due to Public Law
113–98.’’
2. HRSA 99–5: Remove Payment
Information question and check boxes
(Applicable only to: (1) Hospitals which
have not previously participated in the
CHGME Payment Program, and (2)
hospitals in which financial institution
information has changed since
submission of its last application).
Need and Proposed Use of the
Information: Data on the number of FTE
residents trained are collected from
children’s hospitals applying for
CHGME Payment Program funding.
These data are used to determine the
amount of direct and indirect medical
education payments to be distributed to
participating children’s hospitals.
Indirect medical education payments
will also be derived from a formula that
requires the reporting of discharges,
beds, and case mix index information
from participating children’s hospitals.
As required by legislation, the FTE
resident assessment shall determine any
changes to the FTE resident counts
initially reported to the CHGME
Payment Program.
Likely Respondents: The likely
respondents include both the estimated
60 children’s hospitals that apply and
receive CHGME Payment Program
funding, as well as the 30 auditors
contracted by HRSA to perform the FTE
resident assessments of all the
children’s hospitals participating in the
CHGME Payment Program. Children’s
hospitals applying for CHGME Payment
Program funding are required by the
CHGME Payment Program statute to
submit data on the number of FTE
residents trained in an annual
application. Once funded by the
CHGME Payment Program, these same
children’s hospitals are required to
submit audited data on the number of
FTE residents trained during the Federal
fiscal year to participate in the
reconciliation payment process.
Contracted auditors are requested by
HRSA to submit assessed data on the
number of FTE residents trained by the
children’s hospitals participating in the
CHGME Payment Program in an FTE
resident assessment summary.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Form name
Application Cover Letter (Initial and Reconciliation) ............
HRSA 99 (Initial and Reconciliation) ...................................
HRSA 99–1 (Initial) ..............................................................
HRSA 99–1 (Reconciliation) ................................................
HRSA 99–1 (Supplemental) (FTE Resident Assessment) ..
HRSA 99–2 (Initial) ..............................................................
HRSA 99–2 (Reconciliation) ................................................
HRSA 99–4 (Reconciliation) ................................................
HRSA 99–5 (Initial and Reconciliation) ...............................
CFO Form Letter (Initial and Reconciliation) .......................
Exhibit 2 (Initial and Reconciliation) ....................................
Exhibit 3 (Initial and Reconciliation) ....................................
Exhibit 4 (Initial and Reconciliation) ....................................
FTE Resident Assessment Cover Letter (FTE Resident
Assessment) .....................................................................
Conversation Record (FTE Resident Assessment) .............
Exhibit C (FTE Resident Assessment) ................................
Exhibit F (FTE Resident Assessment) ................................
Exhibit N (FTE Resident Assessment) ................................
Exhibit O(1) (FTE Resident Assessment) ...........................
Exhibit O(2) (FTE Resident Assessment) ...........................
Exhibit P (FTE Resident Assessment) ................................
Exhibit P(2) (FTE Resident Assessment) ............................
Exhibit S (FTE Resident Assessment) ................................
Exhibit T (FTE Resident Assessment) ................................
Exhibit T(1) (FTE Resident Assessment) ............................
Exhibit 1 (FTE Resident Assessment) .................................
Exhibit 2 (FTE Resident Assessment) .................................
Exhibit 3 (FTE Resident Assessment) .................................
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Frm 00063
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
60
60
60
60
30
60
60
60
60
60
60
60
60
120
120
60
60
60
60
60
60
120
120
120
120
120
0.33
0.33
26.5
6.5
3.67
11.33
3.67
12.5
0.33
0.33
0.33
0.33
0.33
39.6
39.6
1,590
390
220.2
679.8
220.2
750
39.6
39.6
39.6
39.6
39.6
30
30
30
30
30
30
30
30
30
30
30
30
30
30
30
Fmt 4703
2
2
1
1
2
1
1
1
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
60
60
60
60
60
60
60
60
60
60
60
60
60
60
60
0.33
3.67
3.67
3.67
3.67
3.67
26.5
3.67
3.67
3.67
3.67
3.67
0.33
0.33
0.33
19.8
220.2
220.2
220.2
220.2
220.2
1590
220.2
220.2
220.2
220.2
220.2
19.8
19.8
19.8
Sfmt 4703
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40322
Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Exhibit 4 (FTE Resident Assessment) .................................
30
2
60
0.33
19.8
Total ..............................................................................
* 90
........................
* 90
........................
8018.4
* The total is 90 because the same hospitals and auditors are completing the forms.
HRSA specifically requests comments
on (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.
Jason E. Bennett,
Director, Division of Executive Secretariat.
[FR Doc. 2016–14656 Filed 6–20–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: 4040–0005 30-day
notice]
Agency Information Collection
Request; 30-Day Public Comment
Request, Grants.gov
AGENCY:
Office of the Secretary, HHS.
ACTION:
OMB number, to Ed.Calimag@hhs.gov,
or call the Reports Clearance Office on
(202) 690–6162. Send written comments
and recommendations for the proposed
information collections within 30 days
of this notice directly to the Grants.gov
OMB Desk Officer; faxed to OMB at
202–395–6974.
Notice.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995,
Grants.gov (EGOV), Department of
Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this burden
estimate 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.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, email your request,
including your address, phone number,
Proposed Project
Application for Federal Assistance SF–
424 Individual
3 Year Extension
Office: Grants.gov
Abstract: 4040–0005 is an OMBapproved collection. This information
collection is used by more than 2
Federal grant-making entities, but not by
HHS. Therefore, burden hours are not
reported for HHS. Since this IC is used
by more than 2 Federal grant-making
entities, Grants.gov seeks to assign this
as a common form. This IC expires on
July 31, 2016. We are requesting a threeyear clearance for 4040–0005 and that
the form be designated as a common
forms.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses per
respondent
Number of
respondents
Average
burden hours
per response
Forms
(If necessary)
Type of respondent
Application for Federal Assistance
SF–424 Individual.
Grant Applicant ................................
0
1
1
0
Total ...........................................
...........................................................
0
........................
........................
0
Terry S. Clark,
Asst. Information Collection Clearance
Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–14476 Filed 6–20–16; 8:45 am]
National Institutes of Health
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4151–AE–P
National Library of Medicine Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of a meeting of the Board
of Scientific Counselors, National
Center for Biotechnology Information.
VerDate Sep<11>2014
18:37 Jun 20, 2016
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Total burden
hours
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for review, discussion, and evaluation of
E:\FR\FM\21JNN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40320-40322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this ICR must be received no later than August 22,
2016.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N-39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Children's Hospitals Graduate
Medical Education Payment Program Application and Full-Time Equivalent
Resident Assessment Forms OMB No. 0915-0247 Revision.
Abstract: The Children's Hospitals Graduate Medical Education
(CHGME) Payment Program was enacted by Public Law 106-129, and
reauthorized by the CHGME Support Reauthorization Act of 2013 (Pub. L.
113-98) to provide Federal support for graduate medical education (GME)
to freestanding children's hospitals. The legislation indicates that
eligible children's hospitals will receive payments for both direct and
indirect medical education. The CHGME Payment Program application and
full-time equivalent (FTE) resident assessment forms received OMB
clearance on June 30, 2014.
The CHGME Support Reauthorization Act of 2013 included a provision
to
[[Page 40321]]
allow certain newly qualified children's hospitals to apply for CHGME
Payment Program funding. The CHGME Payment Program application forms
have been revised to accommodate the new statute. In addition, a
payment question included in the CHGME Payment Program application
forms has been removed, since the participating children's hospitals
are now required to electronically communicate their financial
information to the Payment Management System through the Electronic
Handbook.
The form changes are only applicable to the HRSA 99-1 (also known
as Exhibit O (2)) and the HRSA 99-5. All other hospital and auditor
forms are the same as currently approved. The changes to the HRSA 99-1
and HRSA 99-5 forms require OMB approval and are as follows:
1. HRSA 99-1: Add additional description to Line 4.06 (both Page 2
and Page 2 Supplemental), 5.06 and 6.06. The current description is,
``FTE adjusted cap.'' The new description will be, ``FTE adjusted cap
or 2013 CHGME Reauthorization cap due to Public Law 113-98.''
2. HRSA 99-5: Remove Payment Information question and check boxes
(Applicable only to: (1) Hospitals which have not previously
participated in the CHGME Payment Program, and (2) hospitals in which
financial institution information has changed since submission of its
last application).
Need and Proposed Use of the Information: Data on the number of FTE
residents trained are collected from children's hospitals applying for
CHGME Payment Program funding. These data are used to determine the
amount of direct and indirect medical education payments to be
distributed to participating children's hospitals. Indirect medical
education payments will also be derived from a formula that requires
the reporting of discharges, beds, and case mix index information from
participating children's hospitals. As required by legislation, the FTE
resident assessment shall determine any changes to the FTE resident
counts initially reported to the CHGME Payment Program.
Likely Respondents: The likely respondents include both the
estimated 60 children's hospitals that apply and receive CHGME Payment
Program funding, as well as the 30 auditors contracted by HRSA to
perform the FTE resident assessments of all the children's hospitals
participating in the CHGME Payment Program. Children's hospitals
applying for CHGME Payment Program funding are required by the CHGME
Payment Program statute to submit data on the number of FTE residents
trained in an annual application. Once funded by the CHGME Payment
Program, these same children's hospitals are required to submit audited
data on the number of FTE residents trained during the Federal fiscal
year to participate in the reconciliation payment process. Contracted
auditors are requested by HRSA to submit assessed data on the number of
FTE residents trained by the children's hospitals participating in the
CHGME Payment Program in an FTE resident assessment summary.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Application Cover Letter 60 2 120 0.33 39.6
(Initial and Reconciliation)...
HRSA 99 (Initial and 60 2 120 0.33 39.6
Reconciliation)................
HRSA 99-1 (Initial)............. 60 1 60 26.5 1,590
HRSA 99-1 (Reconciliation)...... 60 1 60 6.5 390
HRSA 99-1 (Supplemental) (FTE 30 2 60 3.67 220.2
Resident Assessment)...........
HRSA 99-2 (Initial)............. 60 1 60 11.33 679.8
HRSA 99-2 (Reconciliation)...... 60 1 60 3.67 220.2
HRSA 99-4 (Reconciliation)...... 60 1 60 12.5 750
HRSA 99-5 (Initial and 60 2 120 0.33 39.6
Reconciliation)................
CFO Form Letter (Initial and 60 2 120 0.33 39.6
Reconciliation)................
Exhibit 2 (Initial and 60 2 120 0.33 39.6
Reconciliation)................
Exhibit 3 (Initial and 60 2 120 0.33 39.6
Reconciliation)................
Exhibit 4 (Initial and 60 2 120 0.33 39.6
Reconciliation)................
FTE Resident Assessment Cover 30 2 60 0.33 19.8
Letter (FTE Resident
Assessment)....................
Conversation Record (FTE 30 2 60 3.67 220.2
Resident Assessment)...........
Exhibit C (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit F (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit N (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit O(1) (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit O(2) (FTE Resident 30 2 60 26.5 1590
Assessment)....................
Exhibit P (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit P(2) (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit S (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit T (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit T(1) (FTE Resident 30 2 60 3.67 220.2
Assessment)....................
Exhibit 1 (FTE Resident 30 2 60 0.33 19.8
Assessment)....................
Exhibit 2 (FTE Resident 30 2 60 0.33 19.8
Assessment)....................
Exhibit 3 (FTE Resident 30 2 60 0.33 19.8
Assessment)....................
[[Page 40322]]
Exhibit 4 (FTE Resident 30 2 60 0.33 19.8
Assessment)....................
-------------------------------------------------------------------------------
Total....................... * 90 .............. * 90 .............. 8018.4
----------------------------------------------------------------------------------------------------------------
* The total is 90 because the same hospitals and auditors are completing the forms.
HRSA specifically requests comments on (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.
Jason E. Bennett,
Director, Division of Executive Secretariat.
[FR Doc. 2016-14656 Filed 6-20-16; 8:45 am]
BILLING CODE 4165-15-P
