82 FR 41966 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 170 (September 5, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 170 (September 5, 2017)
| Page Range | 41966-41967 | |
| FR Document | 2017-18738 |
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)] [Notices] [Pages 41966-41967] From the Federal Register Online [www.thefederalregister.org] [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 http://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 http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 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
![41966 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
explaining the development of their the necessity and utility of the proposed Under the PRA (44 U.S.C. 3501–
QBP status. The technical report is information collection for the proper 3520), federal agencies must obtain
provided in writing by electronic mail performance of the agency’s functions, approval from the Office of Management
to the MA organization. If, after the accuracy of the estimated burden, and Budget (OMB) for each collection of
reviewing the technical report, the MA ways to enhance the quality, utility, and information they conduct or sponsor.
organization believes that CMS was clarity of the information to be The term ‘‘collection of information’’ is
incorrect in its QBP determination, collected, and the use of automated defined in 44 U.S.C. 3502(3) and 5 CFR
within 10 calendar days the MA collection techniques or other forms of 1320.3(c) and includes agency requests
organization may request an appeal to information technology to minimize the or requirements that members of the
be conducted by a hearing officer information collection burden. public submit reports, keep records, or
designated by CMS. The hearing DATES: Comments must be received by provide information to a third party.
officer’s decision is final and binding on November 6, 2017. Section 3506(c)(2)(A) of the PRA
both the MA organization and CMS. The requires federal agencies to publish a
hearing officer is required to issue his/ ADDRESSES: When commenting, please 60-day notice in the Federal Register
her decision on or before May 15 of the reference the document identifier or concerning each proposed collection of
year preceding the year in which the OMB control number. To be assured information, including each proposed
contract for which the QBP to be consideration, comments and extension or reinstatement of an existing
applied will be offered. Form Number: recommendations must be submitted in collection of information, before
CMS–10346 (OMB control number: any one of the following ways: submitting the collection to OMB for
0938–1129); Frequency: Yearly; Affected 1. Electronically. You may send your approval. To comply with this
Public: Private sector (Business or other comments electronically to http:// requirement, CMS is publishing this
for-profits and Not-for-profit www.regulations.gov. Follow the notice.
institutions); Number of Respondents: instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’ Information Collection
500; Total Annual Responses: 20; Total
Annual Hours: 160. (For policy to find the information collection 1. Type of Information Collection
questions regarding this collection document(s) that are accepting Request: Extension without change of a
contact Sarah Gaillot at 410–786–4637). comments. currently approved collection; Title of
2. By regular mail. You may mail Information Collection: Clinical
Dated: August 30, 2017.
written comments to the following Laboratory Improvement Amendments
William N. Parham, III, of 1988 (CLIA) Budget Workload
address: CMS, Office of Strategic
Director, Paperwork Reduction Staff, Office Reports and Supporting Regulations;
Operations and Regulatory Affairs,
of Strategic Operations and Regulatory Use: We will use the collected
Affairs. Division of Regulations Development,
Attention: Document Identifier/OMB information to determine the amount of
[FR Doc. 2017–18740 Filed 9–1–17; 8:45 am]
Control Number _________, Room C4– Federal reimbursement for surveys
BILLING CODE 4120–01–P conducted. Use of the information
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850. includes program evaluation, audit,
To obtain copies of a supporting budget formulation and budget
DEPARTMENT OF HEALTH AND approval. Form CMS–102 is a multi-
HUMAN SERVICES statement and any related forms for the
proposed collection(s) summarized in purpose form designed to capture and
Centers for Medicare & Medicaid this notice, you may make your request record all budget and expenditure data.
Services using one of following: Form CMS–105 captures the annual
1. Access CMS’ Web site address at projected CLIA workload that the State
[Document Identifiers: CMS–102 and CMS– survey agency will accomplish. Our
105, and CMS–10631] http://www.cms.hhs.gov/
PaperworkReductionActof1995. regional offices also use the information
to approve the annual projected CLIA
Agency Information Collection 2. Email your request, including your
workload. The information is required
Activities: Proposed Collection; address, phone number, OMB number,
as part of the section 1864 agreement
Comment Request and CMS document identifier, to
with the state. Form Numbers: CMS–102
Paperwork@cms.hhs.gov.
AGENCY: Centers for Medicare & and CMS–105 (OMB control number:
3. Call the Reports Clearance Office at 0938–0599); Frequency: Quarterly;
Medicaid Services, HHS.
(410) 786–1326. Affected Public: State, Local, or Tribal
ACTION: Notice.
FOR FURTHER INFORMATION CONTACT: Governments; Number of Respondents:
SUMMARY: The Centers for Medicare & William Parham at (410) 786–4669. 50; Total Annual Responses: 50; Total
Medicaid Services (CMS) is announcing SUPPLEMENTARY INFORMATION: Annual Hours: 1,700. (For policy
an opportunity for the public to questions regarding this collection
comment on CMS’ intention to collect Contents contact Jeffrey Pleines at 410–786–
information from the public. Under the This notice sets out a summary of the 0684.)
Paperwork Reduction Act of 1995 (the use and burden associated with the 2. Type of Information Collection
PRA), federal agencies are required to following information collections. More Request: Revision of a currently
publish notice in the Federal Register detailed information can be found in approved collection; Title of
concerning each proposed collection of each collection’s supporting statement Information Collection: The PACE
information (including each proposed and associated materials (see Organization Application Process in 42
mstockstill on DSK30JT082PROD with NOTICES
extension or reinstatement of an existing ADDRESSES). CFR part 460; Use: Initial application
collection of information) and to allow requirements for the PACE program are
CMS–102 and CMS–105 Clinical Laboratory
60 days for public comment on the Improvement Amendments of 1988 (CLIA)
currently set forth in 42 CFR 460.12 and
proposed action. Interested persons are Budget Workload Reports and Supporting in the PACE Manual, Ch. 17. Until
invited to send comments regarding our Regulations recently, the submission of initial and
burden estimates or any other aspect of CMS–10631 The PACE Organization SAE PACE applications and supporting
this collection of information, including Application Process in 42 CFR part 460 information was in paper format. These
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![Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41967
applications are often hundreds of pages safety or effectiveness. This initially approved on May 10, 2004.
long, expensive to reproduce and determination will allow FDA to ENJUVIA is indicated for treatment of
transmit, and administratively approve abbreviated new drug moderate to severe vasomotor symptoms
inefficient, as staff reviewing different applications (ANDAs) for ENJUVIA due to menopause and treatment of
parts of the application are located in (estrogens, conjugated synthetic B) moderate to severe vaginal dryness and
different physical locations and must tablets, 0.625 mg and 1.25 mg, if all pain with intercourse, as well as
receive hard copies of the material. other legal and regulatory requirements symptoms of vulvar and vaginal atrophy
However, beginning in 2016 and 2017, are met. due to menopause.
initial and SAE PACE applications, FOR FURTHER INFORMATION CONTACT: In 2016, Teva notified FDA that
respectively, are being submitted via a Bronwen Blass, Center for Drug ENJUVIA (estrogens, conjugated
new automated, electronic submission Evaluation and Research, Food and synthetic B) tablets, 0.625 mg and 1.25
process. As with initial applications, an Drug Administration, 10903 New mg, were being discontinued, and FDA
application also must be submitted for Hampshire Ave., Bldg. 51, Rm. 6228, moved those drug products to the
a PO that seeks to expand its service Silver Spring, MD 20993–0002, 301– ‘‘Discontinued Drug Product List’’
area and/or add a new service site, and 796–5092. section of the Orange Book.
with OMB approval, an automated Foley & Lardner submitted a citizen
SUPPLEMENTARY INFORMATION: In 1984,
application process will now also be petition dated March 8, 2017 (Docket
Congress enacted the Drug Price
required of PACE organizations No. FDA–2017–P–1459), under 21 CFR
Competition and Patent Term
submitting service area expansion 10.30, requesting that the Agency
Restoration Act of 1984 (Pub. L. 98–417)
applications. The collection specific to determine whether ENJUVIA (estrogens,
(the 1984 amendments), which
the application was approved by OMB conjugated synthetic B) tablets, 0.625
authorized the approval of duplicate
for a 3-year period, which expires mg and 1.25 mg, were withdrawn from
versions of drug products under an
March 31, 2020. Approval is now sale for reasons of safety or
ANDA procedure. ANDA applicants
requested for revisions to this currently- effectiveness.
approved collection, which includes must, with certain exceptions, show that
the drug for which they are seeking After considering the citizen petition
modifications to the PACE application. and reviewing Agency records and
Form Number: CMS–10631 (OMB approval contains the same active
ingredient in the same strength and based on the information we have at this
control number: 0938–1326); Frequency: time, FDA has determined under
Once and occasionally; Affected Public: dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was § 314.161 that ENJUVIA (estrogens,
Private sector (Business or other for- conjugated synthetic B) tablets, 0.625
profits and Not-for-profit institutions) previously approved. ANDA applicants
do not have to repeat the extensive mg and 1.25 mg, were not withdrawn
and State, Local, or Tribal Governments; for reasons of safety or effectiveness.
Number of Respondents: 730; Total clinical testing otherwise necessary to
gain approval of a new drug application The petitioner has identified no data or
Annual Responses: 84; Total Annual other information suggesting that these
Hours: 4,626. (For policy questions (NDA).
The 1984 amendments include what products were withdrawn for reasons of
regarding this collection contact Stacy safety or effectiveness. We have
Davis at 410–786–7813.) is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. carefully reviewed our files for records
Dated: August 30, 2017. 355(j)(7)), which requires FDA to concerning the withdrawal of ENJUVIA
William N. Parham, III, publish a list of all approved drugs. (estrogens, conjugated synthetic B)
Director, Paperwork Reduction Staff, Office FDA publishes this list as part of the tablets, 0.625 mg and 1.25 mg, from sale.
of Strategic Operations and Regulatory ‘‘Approved Drug Products With We have also independently evaluated
Affairs. Therapeutic Equivalence Evaluations,’’ relevant literature and data for possible
[FR Doc. 2017–18738 Filed 9–1–17; 8:45 am] which is known generally as the postmarketing adverse events. We have
BILLING CODE 4120–01–P ‘‘Orange Book.’’ Under FDA regulations, found no information that would
drugs are removed from the list if the indicate that these drug products were
Agency withdraws or suspends withdrawn from sale for reasons of
DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA safety or effectiveness.
HUMAN SERVICES for reasons of safety or effectiveness or Accordingly, the Agency will
if FDA determines that the listed drug continue to list ENJUVIA (estrogens,
Food and Drug Administration
was withdrawn from sale for reasons of conjugated synthetic B) tablets, 0.625
[Docket No. FDA–2017–P–1459] safety or effectiveness (21 CFR 314.162). mg and 1.25 mg, in the ‘‘Discontinued
A person may petition the Agency to Drug Product List’’ section of the Orange
Determination That ENJUVIA determine, or the Agency may Book. The ‘‘Discontinued Drug Product
(Estrogens, Conjugated Synthetic B) determine on its own initiative, whether List’’ delineates, among other items,
Tablets, 0.625 Milligrams and 1.25 a listed drug was withdrawn from sale drug products that have been
Milligrams, Were Not Withdrawn From for reasons of safety or effectiveness. discontinued from marketing for reasons
Sale for Reasons of Safety or This determination may be made at any other than safety or effectiveness.
Effectiveness time after the drug has been withdrawn ANDAs that refer to ENJUVIA
AGENCY: Food and Drug Administration, from sale, but must be made prior to (estrogens, conjugated synthetic B)
HHS. approving an ANDA that refers to the tablets, 0.625 mg and 1.25 mg, may be
listed drug (§ 314.161 (21 CFR 314.161)). approved by the Agency as long as they
mstockstill on DSK30JT082PROD with NOTICES
ACTION: Notice.
FDA may not approve an ANDA that meet all other legal and regulatory
SUMMARY: The Food and Drug does not refer to a listed drug. requirements for the approval of
Administration (FDA or Agency) has ENJUVIA (estrogens, conjugated ANDAs. If FDA determines that labeling
determined that ENJUVIA (estrogens, synthetic B) tablets, 0.625 mg and 1.25 for this drug product should be revised
conjugated synthetic B) tablets, 0.625 mg, is the subject of NDA 021443, held to meet current standards, the Agency
milligrams (mg) and 1.25 mg, were not by Teva Branded Pharmaceutical will advise ANDA applicants to submit
withdrawn from sale for reasons of Products R&D, Inc. (Teva), and was such labeling.
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Document Created: 2017-09-02 03:25:20
Document Modified: 2017-09-02 03:25:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by November 6, 2017. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 41966 |
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