Agency Information Collection Activities: Proposed Collection; Comment Request, 25059-25060 [2019-11227]

Download as PDF 25059 Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average burden per response (in hours) Number of responses per respondent Total burden (in hours) Form name Healthy behavior support staff .......... Site Visit Discussion Guide .............. Innovation Site Visit Discussion Guide. Site Visit Discussion Guide .............. Innovation Site Visit Discussion Guide. 16 2 1 1 1 45/60 16 2 16 2 1 1 1 45/60 16 2 ........................................................... ........................ ........................ ........................ 84 Clinical providers ............................... Total ........................................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–11220 Filed 5–29–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10701] 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 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 July 29, 2019. SUMMARY: jbell on DSK3GLQ082PROD with NOTICES Number of respondents Type of respondents VerDate Sep<11>2014 18:08 May 29, 2019 Jkt 247001 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’ website address at https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork ReductionActof1995/PRA-Listing.html. 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 N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: ADDRESSES: 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–10701 Medicare Beneficiary Experiences With Care Survey System (MBECS). PO 00000 Frm 00032 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: New collection (Request for a new OMB control number); Title of Information Collection: Medicare Beneficiary Experiences with Care Survey System; Use: The MBECS system is designed to conduct 1–2 surveys per year on priority groups of interest, thereby allowing CMS OMH to respond quickly to the data needs of stakeholders with interests in these underrepresented groups. Data collected through the MBECS system will be used to better understand—and thus serve the needs of—Medicare beneficiaries in minority populations. The core questionnaire will collect information on communication with medical professionals, coordination of health care, experiences getting needed health care, experiences with personal doctors and specialists, and key demographics. Data will be compared to benchmarks from the FFS CAHPS, MA CAHPS, and NAM CAHPS surveys. The populationspecific questionnaire module will collect information about issues most relevant for particular minority groups; population-specific modules will be E:\FR\FM\30MYN1.SGM 30MYN1 25060 Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices described in individual information collection requests. These data will be compared to benchmarks from the relevant CAHPS source surveys when available. Collection of these data from people who have been identified through CMS administrative data and administrative flags as part of specific minority populations will also serve as a critical validation step of this method for identifying difficult-to-study populations, thus making it easier to study beneficiaries in these groups in the future. Form Number: CMS–10701 (OMB control number: 0938–NEW); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 10,000; Total Annual Responses: 10,000; Total Annual Hours: 3,333. (For policy questions regarding this collection contact Luis Perez at 410–786–8557.) Dated: May 23, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993–0002, 240– 402–4246. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, May 10, 2019 (84 FR 20633), in FR Doc. 2019– 09692, the following correction is made: On page 20633, in the first column, in the headings of the document, ‘‘[Docket No. FDA–2019–D–1798]’’ is corrected to read ‘‘[Docket No. FDA–2018–D–1456].’’ Dated: May 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–11313 Filed 5–29–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–4851] Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness [FR Doc. 2019–11227 Filed 5–29–19; 8:45 am] BILLING CODE 4120–01–P AGENCY: Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2018–D–1456] Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Overthe-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability’’ that appeared in the Federal Register of May 10, 2019. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:08 May 29, 2019 Jkt 247001 The Food and Drug Administration (FDA or Agency) has determined that LUPRON (leuprolide acetate) injection, 1 milligram (mg)/0.2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Meadow Platt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993–0002, 301– 796–1830, Meadow.Platt@fda.hhs.gov. 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 SUMMARY: Food and Drug Administration AGENCY: Notice. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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. LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is the subject of NDA 019010, held by Abbvie Endocrine, Inc., and initially approved on April 9, 1985. LUPRON is indicated for palliative treatment of advanced prostatic cancer. LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Hetero Labs Limited submitted a citizen petition dated December 20, 2018 (Docket No. FDA–2018–P–4851), under 21 CFR 10.30, requesting that the Agency determine whether LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was 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 LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25059-25060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10701]


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 July 29, 2019.

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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    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 N. 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-10701 Medicare Beneficiary Experiences With Care Survey System 
(MBECS).

    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: 
Medicare Beneficiary Experiences with Care Survey System; Use: The 
MBECS system is designed to conduct 1-2 surveys per year on priority 
groups of interest, thereby allowing CMS OMH to respond quickly to the 
data needs of stakeholders with interests in these underrepresented 
groups. Data collected through the MBECS system will be used to better 
understand--and thus serve the needs of--Medicare beneficiaries in 
minority populations. The core questionnaire will collect information 
on communication with medical professionals, coordination of health 
care, experiences getting needed health care, experiences with personal 
doctors and specialists, and key demographics. Data will be compared to 
benchmarks from the FFS CAHPS, MA CAHPS, and NAM CAHPS surveys. The 
population-specific questionnaire module will collect information about 
issues most relevant for particular minority groups; population-
specific modules will be

[[Page 25060]]

described in individual information collection requests. These data 
will be compared to benchmarks from the relevant CAHPS source surveys 
when available.
    Collection of these data from people who have been identified 
through CMS administrative data and administrative flags as part of 
specific minority populations will also serve as a critical validation 
step of this method for identifying difficult-to-study populations, 
thus making it easier to study beneficiaries in these groups in the 
future. Form Number: CMS-10701 (OMB control number: 0938-NEW); 
Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 10,000; Total Annual Responses: 
10,000; Total Annual Hours: 3,333. (For policy questions regarding this 
collection contact Luis Perez at 410-786-8557.)

    Dated: May 23, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-11227 Filed 5-29-19; 8:45 am]
 BILLING CODE 4120-01-P

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