Agency Information Collection Activities: Submission for OMB Review; Comment Request, 32926-32927 [2019-14719]

Download as PDF 32926 Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices Issuers in the small group market may use the draft federal standard small group notices released in the June 26, 2014 bulletin ‘‘Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market’’, or any forms of the notice otherwise permitted by applicable laws and regulations. States that are enforcing the guaranteed renewability provisions of the Affordable Care Act may develop their own standard notices for product discontinuances, renewals, or both, provided the state-developed notices are at least as protective as the federal standard notices. Form Number: CMS– 10527 (OMB control number 0938– 1254); Frequency: Annually; Affected Public: Private Sector, State Governments; Number of Respondents: 1,805; Total Annual Responses: 7,420; Total Annual Hours: 90,331. For policy questions regarding this collection contact Usree Bandyopadhyay at 410– 786–6650. Dated: July 5, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–14693 Filed 7–9–19; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10003] Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information jspears on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:32 Jul 09, 2019 Jkt 247001 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 on the collection(s) of information must be received by the OMB desk officer by August 9, 2019. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806 OR, Email: OIRA_submission@omb.eop.gov 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/ PaperworkReductionActof1995/PRAListing.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 Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 1. Type of Information Collection: Revision with change of a currently approved collection; Title of Information Collection: Notice of Denial of Medical Coverage (or Payment) (NDMCP); Use: Section 1852(g)(1)(B) of the Social Security Act (the Act) requires Medicare health plans to provide enrollees with a written notice in understandable language of the reasons for the denial and a description of the applicable appeals processes. Medicare health plans, including Medicare Advantage plans, cost plans, and Health Care Prepayment Plans (HCPPs), are required to issue the Notice of Denial of Medical Coverage (or Payment) (NDMCP) when a request for either a medical service or payment is denied, in whole or in part. Additionally, the notices inform Medicare enrollees of their right to file an appeal, outlining the steps and timeframes for filing. All Medicare health plans are required to use these standardized notices. In 2013, Medicaid appeal rights were integrated into form CMS–10003 for beneficiaries who are eligible for Medicare and full Medicaid benefits under a State Medicaid plan. These appeal rights are provided in instances where a Medicare health plan enrollee receives full benefits under a State Medical Assistance (Medicaid) program being managed by the plan and the plan denies a service or item that is also subject to Medicaid appeal rights. Changes to the collection from the 60day package to the 30-day package include: • Removal of language related to State Fair Hearings to comply with the change in Medicaid managed care rules at 42 CFR 438.402(c)(1)(i), effective 2017, that all Medicaid managed care denials must now first have a plan-level review before a State Fair Hearing can be requested. • Updates to comply with the Medicare Advantage final rule, published May 23, 2019, Federal Register, 84 FR 23832, effective January 1, 2020, regarding the change in timeframes for Medicare Advantage appeals related to Part B drugs. • Removing the option to delete sections related to expedited payment requests (if applicable); plans are to leave all language regarding fast appeals. Text has been added to the notice informing enrollees they do not have a right to request an expedited appeal if they are asking to be paid back for an item or service already received (42 CFR 422.570(a)). • The addition of language in the instructions that ‘‘applicable integrated plans’’ should follow notification requirements under final rule published E:\FR\FM\10JYN1.SGM 10JYN1 Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 / Notices April 16, 2019, Federal Register, 84 FR 15680, and amended May 23, 2019, Federal Register, 84 FR 23832, effective January 1, 2021. • The addition of instructions for MA–PDs to enter text in the free text field ‘‘why did we deny your request?’’ when they have determined that the requested drug being denied is covered under Part D. Form Number: CMS–10003 (OMB control number: 0938–0829); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 694; Total Annual Responses: 9,373,200; Total Annual Hours: 1,561,575. (For policy questions regarding this collection contact Staci Paige at 410–786–1943.) Dated: July 5, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–14719 Filed 7–9–19; 8:45 am] BILLING CODE 4120–01–P Food and Drug Administration [Docket No. FDA–2019–N–2338] Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is jspears on DSK30JT082PROD with NOTICES 090419 090463 090499 090790 091260 091373 091379 200164 200832 200878 ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ April 22, 2009 ................................ August 30, 2010 ............................ April 22, 2009 ................................ October 6, 2010 ............................. August 25, 2011 ............................ April 22, 2011 ................................ November 6, 2012 ......................... September 25, 2012 ...................... October 15, 2012 ........................... April 20, 2012 ................................ 201294 ............................................ 201503 ............................................ 201505 ............................................ August 3, 2012 .............................. March 8, 2013 ............................... October 15, 2012 ........................... 201508 201950 202078 202079 202244 202476 202477 202884 ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ August 3, 2012 .............................. September 12, 2013 ...................... May 14, 2013 ................................. January 10, 2014 ........................... December 31, 2012 ....................... May 14, 2013 ................................. July 1, 2013 ................................... December 4, 2012 ......................... 203021 ............................................ 203026 ............................................ May 22, 2012 ................................. March 21, 2013 ............................. 205258 ............................................ April 3, 2014 .................................. Jkt 247001 Kristiana Brugger, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301–796–3600. FDA approved the following ANDAs on the dates indicated in the table, for the conditions of use found in the reference listed drug for each application: SUPPLEMENTARY INFORMATION: Hydrochlorothiazide Tablets USP, 25 milligrams (mg) and 50 mg. Azithromycin Tablets, 250 mg. Azithromycin Tablets, 600 mg. Azithromycin Tablets, 500 mg. Hydrochlorothiazide Capsules, 12.5 mg. Donepezil Hydrochloride Tablets, 5 mg and 10 mg. Losartan Potassium and Hydrochlorothiazide Tablets, 50 mg/12.5 mg, 100 mg/12.5mg, and 100 mg/25 mg. Mycophenolate Mofetil Capsules, 250 mg. Perindopril Erbumine Tablets, 2 mg, 4 mg, and 8 mg. Mycophenolate Mofetil Tablets, 500 mg. Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg. Cevimeline Hydrochloride Capsules, 30 mg. Naratriptan Tablets USP, 1 mg and 2.5 mg. Sildenafil Citrate Tablets, 20 mg. Tolterodine Tartrate Tablets, 1 mg and 2 mg. Irbesartan Tablets USP, 75 mg, 150 mg, and 300 mg. Verapamil Hydrochloride Extended-Release Tablets USP, 120 mg, 180 mg, and 240 mg. Montelukast Sodium Tablets, 10 mg. Cabergoline Tablets, 0.5 mg. Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg, and 300 mg/12.5 mg. Montelukast Sodium Chewable Tablets, 4 mg and 5 mg. Rasagiline Mesylate Tablets, 0.5 mg and 1 mg. Zolmitriptan Tablets, 2.5 mg and 5 mg. Candesartan Cilexetil Tablets, 4 mg, 8 mg, 16 mg, and 32 mg. Rizatriptan Benzoate Tablets, 5 mg and 10 mg. Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg. Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg and 10 mg. Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16 mg/12.5 mg, 32 mg/12.5 mg, and 32 mg/25 mg. Nevirapine Tablets USP, 200 mg. Valsartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. Nevirapine Extended-Release Tablets, 400 mg. October 3, 2007 ............................. July 13, 2011 ................................. July 13, 2011 ................................. July 13, 2011 ................................. May 16, 2008 ................................. June 2, 2011 .................................. October 6, 2010 ............................. 18:32 Jul 09, 2019 FOR FURTHER INFORMATION CONTACT: Name of drug product ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ VerDate Sep<11>2014 Approval is withdrawn as of July 10, 2019. Date of approval 040774 065507 065508 065509 078389 078841 090150 However, after these drugs were approved, FDA became aware of concerns involving material manufactured at two Apotex facilities, at least one of which was named in each of these applications. The facilities involved were Apotex Private Research withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, has requested withdrawal of these applications and has waived its opportunity for a hearing. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES SUMMARY: ANDA 32927 Ltd. (Federal Employer Identification (FEI) number: 3006076314) and Apotex Pharmachem India Private Ltd. (FEI: 3005466325). The application numbers for the impacted ANDAs are listed above. In January 2018, Apotex requested withdrawal of the above PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 ANDAs and waived its opportunity for a hearing. FDA interprets this withdrawal request as a request under § 314.150(d) (21 CFR 314.150(d)). Therefore, for the reasons discussed above, and pursuant to Apotex’s request, FDA is withdrawing approval E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32926-32927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14719]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10003]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by August 9, 2019.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR, Email: 
[email protected]
    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 Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection: Revision with change of a 
currently approved collection; Title of Information Collection: Notice 
of Denial of Medical Coverage (or Payment) (NDMCP); Use: Section 
1852(g)(1)(B) of the Social Security Act (the Act) requires Medicare 
health plans to provide enrollees with a written notice in 
understandable language of the reasons for the denial and a description 
of the applicable appeals processes. Medicare health plans, including 
Medicare Advantage plans, cost plans, and Health Care Prepayment Plans 
(HCPPs), are required to issue the Notice of Denial of Medical Coverage 
(or Payment) (NDMCP) when a request for either a medical service or 
payment is denied, in whole or in part. Additionally, the notices 
inform Medicare enrollees of their right to file an appeal, outlining 
the steps and timeframes for filing. All Medicare health plans are 
required to use these standardized notices. In 2013, Medicaid appeal 
rights were integrated into form CMS-10003 for beneficiaries who are 
eligible for Medicare and full Medicaid benefits under a State Medicaid 
plan. These appeal rights are provided in instances where a Medicare 
health plan enrollee receives full benefits under a State Medical 
Assistance (Medicaid) program being managed by the plan and the plan 
denies a service or item that is also subject to Medicaid appeal 
rights.
    Changes to the collection from the 60-day package to the 30-day 
package include:
     Removal of language related to State Fair Hearings to 
comply with the change in Medicaid managed care rules at 42 CFR 
438.402(c)(1)(i), effective 2017, that all Medicaid managed care 
denials must now first have a plan-level review before a State Fair 
Hearing can be requested.
     Updates to comply with the Medicare Advantage final rule, 
published May 23, 2019, Federal Register, 84 FR 23832, effective 
January 1, 2020, regarding the change in timeframes for Medicare 
Advantage appeals related to Part B drugs.
     Removing the option to delete sections related to 
expedited payment requests (if applicable); plans are to leave all 
language regarding fast appeals. Text has been added to the notice 
informing enrollees they do not have a right to request an expedited 
appeal if they are asking to be paid back for an item or service 
already received (42 CFR 422.570(a)).
     The addition of language in the instructions that 
``applicable integrated plans'' should follow notification requirements 
under final rule published

[[Page 32927]]

April 16, 2019, Federal Register, 84 FR 15680, and amended May 23, 
2019, Federal Register, 84 FR 23832, effective January 1, 2021.
     The addition of instructions for MA-PDs to enter text in 
the free text field ``why did we deny your request?'' when they have 
determined that the requested drug being denied is covered under Part 
D.
    Form Number: CMS-10003 (OMB control number: 0938-0829); Frequency: 
Yearly; Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 694; Total Annual Responses: 9,373,200; Total Annual 
Hours: 1,561,575. (For policy questions regarding this collection 
contact Staci Paige at 410-786-1943.)

    Dated: July 5, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-14719 Filed 7-9-19; 8:45 am]
 BILLING CODE 4120-01-P
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