Agency Information Collection Activities: Proposed Collection; Comment Request, 41966-41967 [2017-18738]
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Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
explaining the development of their
QBP status. The technical report is
provided in writing by electronic mail
to the MA organization. If, after
reviewing the technical report, the MA
organization believes that CMS was
incorrect in its QBP determination,
within 10 calendar days the MA
organization may request an appeal to
be conducted by a hearing officer
designated by CMS. The hearing
officer’s decision is final and binding on
both the MA organization and CMS. The
hearing officer is required to issue his/
her decision on or before May 15 of the
year preceding the year in which the
contract for which the QBP to be
applied will be offered. Form Number:
CMS–10346 (OMB control number:
0938–1129); Frequency: Yearly; Affected
Public: Private sector (Business or other
for-profits and Not-for-profit
institutions); Number of Respondents:
500; Total Annual Responses: 20; Total
Annual Hours: 160. (For policy
questions regarding this collection
contact Sarah Gaillot at 410–786–4637).
Dated: August 30, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–18740 Filed 9–1–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–102 and CMS–
105, and CMS–10631]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
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
this collection of information, including
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SUMMARY:
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17:43 Sep 01, 2017
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the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and 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 6, 2017.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. 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:
William Parham at (410) 786–4669.
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–102 and CMS–105 Clinical Laboratory
Improvement Amendments of 1988 (CLIA)
Budget Workload Reports and Supporting
Regulations
CMS–10631 The PACE Organization
Application Process in 42 CFR part 460
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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: Extension without change of a
currently approved collection; Title of
Information Collection: Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Budget Workload
Reports and Supporting Regulations;
Use: We will use the collected
information to determine the amount of
Federal reimbursement for surveys
conducted. Use of the information
includes program evaluation, audit,
budget formulation and budget
approval. Form CMS–102 is a multipurpose form designed to capture and
record all budget and expenditure data.
Form CMS–105 captures the annual
projected CLIA workload that the State
survey agency will accomplish. Our
regional offices also use the information
to approve the annual projected CLIA
workload. The information is required
as part of the section 1864 agreement
with the state. Form Numbers: CMS–102
and CMS–105 (OMB control number:
0938–0599); Frequency: Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
50; Total Annual Responses: 50; Total
Annual Hours: 1,700. (For policy
questions regarding this collection
contact Jeffrey Pleines at 410–786–
0684.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: The PACE
Organization Application Process in 42
CFR part 460; Use: Initial application
requirements for the PACE program are
currently set forth in 42 CFR 460.12 and
in the PACE Manual, Ch. 17. Until
recently, the submission of initial and
SAE PACE applications and supporting
information was in paper format. These
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Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
applications are often hundreds of pages
long, expensive to reproduce and
transmit, and administratively
inefficient, as staff reviewing different
parts of the application are located in
different physical locations and must
receive hard copies of the material.
However, beginning in 2016 and 2017,
initial and SAE PACE applications,
respectively, are being submitted via a
new automated, electronic submission
process. As with initial applications, an
application also must be submitted for
a PO that seeks to expand its service
area and/or add a new service site, and
with OMB approval, an automated
application process will now also be
required of PACE organizations
submitting service area expansion
applications. The collection specific to
the application was approved by OMB
for a 3-year period, which expires
March 31, 2020. Approval is now
requested for revisions to this currentlyapproved collection, which includes
modifications to the PACE application.
Form Number: CMS–10631 (OMB
control number: 0938–1326); Frequency:
Once and occasionally; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions)
and State, Local, or Tribal Governments;
Number of Respondents: 730; Total
Annual Responses: 84; Total Annual
Hours: 4,626. (For policy questions
regarding this collection contact Stacy
Davis at 410–786–7813.)
Dated: August 30, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–18738 Filed 9–1–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–1459]
Determination That ENJUVIA
(Estrogens, Conjugated Synthetic B)
Tablets, 0.625 Milligrams and 1.25
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
mstockstill on DSK30JT082PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
milligrams (mg) and 1.25 mg, were not
withdrawn from sale for reasons of
SUMMARY:
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17:43 Sep 01, 2017
Jkt 241001
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for ENJUVIA
(estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Bronwen Blass, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
796–5092.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ENJUVIA (estrogens, conjugated
synthetic B) tablets, 0.625 mg and 1.25
mg, is the subject of NDA 021443, held
by Teva Branded Pharmaceutical
Products R&D, Inc. (Teva), and was
PO 00000
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Fmt 4703
Sfmt 4703
41967
initially approved on May 10, 2004.
ENJUVIA is indicated for treatment of
moderate to severe vasomotor symptoms
due to menopause and treatment of
moderate to severe vaginal dryness and
pain with intercourse, as well as
symptoms of vulvar and vaginal atrophy
due to menopause.
In 2016, Teva notified FDA that
ENJUVIA (estrogens, conjugated
synthetic B) tablets, 0.625 mg and 1.25
mg, were being discontinued, and FDA
moved those drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Foley & Lardner submitted a citizen
petition dated March 8, 2017 (Docket
No. FDA–2017–P–1459), under 21 CFR
10.30, requesting that the Agency
determine whether ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
mg and 1.25 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
mg and 1.25 mg, were not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that these
products were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of ENJUVIA
(estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that these drug products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
mg and 1.25 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to ENJUVIA
(estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
E:\FR\FM\05SEN1.SGM
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Agencies
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41966-41967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18738]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-102 and CMS-105, and CMS-10631]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
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 the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and 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 6, 2017.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. 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: William Parham at (410) 786-4669.
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-102 and CMS-105 Clinical Laboratory Improvement Amendments of
1988 (CLIA) Budget Workload Reports and Supporting Regulations
CMS-10631 The PACE Organization Application Process in 42 CFR part
460
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: Extension without change
of a currently approved collection; Title of Information Collection:
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Budget
Workload Reports and Supporting Regulations; Use: We will use the
collected information to determine the amount of Federal reimbursement
for surveys conducted. Use of the information includes program
evaluation, audit, budget formulation and budget approval. Form CMS-102
is a multi-purpose form designed to capture and record all budget and
expenditure data. Form CMS-105 captures the annual projected CLIA
workload that the State survey agency will accomplish. Our regional
offices also use the information to approve the annual projected CLIA
workload. The information is required as part of the section 1864
agreement with the state. Form Numbers: CMS-102 and CMS-105 (OMB
control number: 0938-0599); Frequency: Quarterly; Affected Public:
State, Local, or Tribal Governments; Number of Respondents: 50; Total
Annual Responses: 50; Total Annual Hours: 1,700. (For policy questions
regarding this collection contact Jeffrey Pleines at 410-786-0684.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: The PACE
Organization Application Process in 42 CFR part 460; Use: Initial
application requirements for the PACE program are currently set forth
in 42 CFR 460.12 and in the PACE Manual, Ch. 17. Until recently, the
submission of initial and SAE PACE applications and supporting
information was in paper format. These
[[Page 41967]]
applications are often hundreds of pages long, expensive to reproduce
and transmit, and administratively inefficient, as staff reviewing
different parts of the application are located in different physical
locations and must receive hard copies of the material. However,
beginning in 2016 and 2017, initial and SAE PACE applications,
respectively, are being submitted via a new automated, electronic
submission process. As with initial applications, an application also
must be submitted for a PO that seeks to expand its service area and/or
add a new service site, and with OMB approval, an automated application
process will now also be required of PACE organizations submitting
service area expansion applications. The collection specific to the
application was approved by OMB for a 3-year period, which expires
March 31, 2020. Approval is now requested for revisions to this
currently-approved collection, which includes modifications to the PACE
application. Form Number: CMS-10631 (OMB control number: 0938-1326);
Frequency: Once and occasionally; Affected Public: Private sector
(Business or other for-profits and Not-for-profit institutions) and
State, Local, or Tribal Governments; Number of Respondents: 730; Total
Annual Responses: 84; Total Annual Hours: 4,626. (For policy questions
regarding this collection contact Stacy Davis at 410-786-7813.)
Dated: August 30, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-18738 Filed 9-1-17; 8:45 am]
BILLING CODE 4120-01-P