Agency Information Collection Activities: Proposed Collection; Comment Request, 64843-64844 [2018-27335]

Download as PDF Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Notices 25. Fu R, Gartlehner G, Grant M, et al. Conducting quantitative synthesis when comparing medical interventions: AHRQ and the Effective Health Care Program. J Clin Epidemiol. 2011 Nov;64(11):1187– 97. doi: 10.1016/j.jclinepi.2010.08.010. PMID: 21477993. 26. Takwoingi Y. Meta-analysis of test accuracy studies in Stata: a bivariate model approach. Version 1.1. 27. Owens DK, Lohr KN, Atkins D, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions— agency for healthcare research and quality and the effective health-care program. J Clin Epidemiol. 2010 May;63(5):513–23. doi: S0895– 4356(09)00093–6 [pii] 10.1016/ j.jclinepi.2009.03.009. PMID: 19595577. 28. Singh S, Chang SM, Matchar DB, et al. Chapter 7: grading a body of evidence on diagnostic tests. J Gen Intern Med. 2012 Jun;27 Suppl 1:S47–55. doi: 10.1007/ s11606–012–2021–9. PMID: 22648675. 29. Berkman ND, Lohr KN, Ansari M, et al. Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective Health Care Program of the Agency for Healthcare Research and Quality: An Update. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Rockville (MD); 2008. 30. Atkins D, Chang S, Gartlehner G, et al. Assessing the Applicability of Studies When Comparing Medical Interventions. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Rockville (MD); 2008. Francis D. Chesley, Jr., Acting Deputy Director. [FR Doc. 2018–27361 Filed 12–17–18; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–10465] 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 amozie on DSK3GDR082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 00:45 Dec 18, 2018 Jkt 247001 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 February 19, 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-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 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 64843 and associated materials (see ADDRESSES). CMS–10465 Minimum Essential Coverage 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 Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Minimum Essential Coverage; Use: The final rule titled ‘‘Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions,’’ published July 1, 2013 (78 FR 39494) designates certain types of health coverage as minimum essential coverage. Other types of coverage, not statutorily designated and not designated as minimum essential coverage in regulation, may be recognized by the Secretary of Health and Human Services (HHS) as minimum essential coverage if certain substantive and procedural requirements are met. To be recognized as minimum essential coverage, the coverage must offer substantially the same consumer protections as those enumerated in the Title I of Affordable Care Act relating to non-grandfathered, individual health insurance coverage to ensure consumers are receiving adequate coverage. The final rule requires sponsors of other coverage that seek to have such coverage recognized as minimum essential coverage to adhere to certain procedures. Sponsoring organizations must submit to HHS certain information about their coverage and an attestation that the plan substantially complies with the provisions of Title I of the Affordable Care Act applicable to nongrandfathered individual health insurance coverage. Sponsors must also provide notice to enrollees informing E:\FR\FM\18DEN1.SGM 18DEN1 64844 Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Notices them that the plan has been recognized as minimum essential coverage for the purposes of the individual coverage requirement. Form Number: CMS– 10465 (OMB control number: 0938– 1189); Frequency: Occasionally; Affected Public: Public and Private sectors; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 52.5. (For policy questions regarding this collection contact Russell Tipps at 301–492–4371). Dated: December 13, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018–27335 Filed 12–17–18; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–4627] Intent To Consider the Appropriate Classification of Hyaluronic Acid Intraarticular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing our intent to consider the appropriate classification of hyaluronic acid (HA) intra-articular products intended for the treatment of pain in osteoarthritis (OA) of the knee. Although HA products intended for this use have been regulated as devices (Procode MOZ; acid, hyaluronic, intra-articular), the current published scientific literature supports that HA achieves its primary intended purpose of treatment of pain in OA of the knee through chemical action within the body. Because HA for this use may not meet the definition of a device, sponsors of HA products who intend to submit a premarket approval application (PMA) or a supplement to a PMA for a change in indications for use, formulation, or route of administration are encouraged to obtain an informal or formal classification and jurisdiction determination through a Pre-Request for Designation (Pre-RFD) or Request for Designation (RFD), respectively, from FDA prior to submission. If a sponsor believes their product meets the device definition, they may provide relevant evidence in the Pre-RFD or RFD. FOR FURTHER INFORMATION CONTACT: Leigh Hayes, Office of Combination amozie on DSK3GDR082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 00:45 Dec 18, 2018 Jkt 247001 Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993, 301–796–8938, Fax: 301– 847–8619, combination@fda.gov. SUPPLEMENTARY INFORMATION: I. Background HA is a linear polysaccharide formed by repeating disaccharide units of Dglucuronic acid and Nacetylglucosamine linked by b (1, 4) and b (1, 3) glycoside bonds (Ref. 1). HA is present throughout the body and in joints where it acts as a structural element (Ref. 2). It is also found in the cavities of synovial joints and plays a role in promoting the viscoelastic properties of the synovial fluid and in joint lubrication (Refs. 3 and 4). Intra-articular administration of exogenous HA has been used to treat pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to certain analgesics (e.g., acetaminophen). Although HA for this use has been regulated as a Class III device (Procode MOZ; acid, hyaluronic, intra-articular), as discussed further below, the current published scientific literature supports that HA achieves its primary intended purpose of the treatment of pain in OA of the knee through chemical action within the body. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)) a device ‘‘does not achieve its primary intended purposes through chemical action within or on the body,’’ among other things. Under FDA’s interpretation of this device definition, products exhibit ‘‘chemical action’’ if they interact at the molecular level with bodily components (e.g., cells or tissues) to mediate (including promoting or inhibiting) a bodily response, or with foreign entities (e.g., organisms or chemicals) to alter that entity’s interaction with the body; and interaction at the molecular level occurs through either chemical reaction (i.e., formation or breaking of covalent bonds), intermolecular forces (e.g., electrostatic interactions), or both (see, e.g., FDA Guidance, ‘‘Classification of Products as Drugs and Devices and Additional Product Classification Issues’’, available at https:// www.fda.gov/RegulatoryInformation/ Guidances/ucm258946.htm). OA pain has a complex pathophysiology and has several components, including: (1) Neuropathic pain (related to a lesion or disease of the somatosensory nervous system); (2) local inflammation; and (3) joint degradation (Ref. 5). During the intra- PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 articular injection, HA is introduced to the synovial fluid of the affected joint. Previously, it was suggested that mechanical or physical actions at the joint (e.g., shock absorption) are responsible for achieving the primary intended purpose of the treatment of pain in OA of the knee; however, the current scientific literature supports that the mechanisms of action of HA also include chemical actions (e.g., chondroprotection, anti-inflammatory effects and cartilage matrix alterations) (Refs. 6 to 9). Published scientific literature supports that intra-articular injection of HA achieves its primary intended purpose of the treatment of pain in OA of the knee through multiple mechanisms (we note that the published scientific literature discussed in this notice is not exhaustive). These include, but are not limited to: (1) Anti-inflammatory effects: Local inflammation is an important part of the pathophysiology of OA joint pain (Ref. 5). As such, the mitigation of inflammation can result in pain relief (Ref. 10). The scientific literature supports that HA acts though chemical action to achieve its anti-inflammatory effects. These effects are mediated through the binding of HA to cellular receptors that include the Cluster of Differentiation 44 Receptor (CD44), Receptor for Hyaluronan Mediated Motility (RHAMM), and Toll-Like Receptor (TLR)2 and TLR4, which alter numerous downstream cell signaling activities and/or pathways resulting in anti-inflammatory effects (Refs. 9, 11, and 12). Some of the downstream antiinflammatory effects discussed in the scientific literature include alteration of cytokines (e.g., Interleukin (IL)-1b) and inducible nitric oxide synthase (iNOS), which all have regulatory roles in inflammatory processes (Ref. 9). (2) Analgesic effects: Joint inflammation is usually characterized by mechanical hyperalgesia, likely caused by an increased mechanosensitivity of joint nociceptors (Ref. 13). The scientific literature supports that HA interacts with cellular receptors (e.g., nociceptors, CD44) to reduce pain (Refs. 2, 8, 9, and 11). For instance, binding of HA to CD44 has been reported to act via signaling pathways to reduce pain, such as by downregulating Prostaglandin E2 (PGE2) and Cyclooxygenase (COX–2) production (Refs. 2 and 11). The literature also reports that HA may also act to relieve pain by activating opioid receptors (Ref. 11). In other words, the literature explains that HA binds to cellular receptors that act to alleviate pain through modification of cellular pain pathways. E:\FR\FM\18DEN1.SGM 18DEN1

Agencies

[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Notices]
[Pages 64843-64844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27335]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10465]


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 February 19, 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 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:

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-10465 Minimum Essential Coverage
    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

    Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Minimum Essential 
Coverage; Use: The final rule titled ``Patient Protection and 
Affordable Care Act; Exchange Functions: Eligibility for Exemptions; 
Miscellaneous Minimum Essential Coverage Provisions,'' published July 
1, 2013 (78 FR 39494) designates certain types of health coverage as 
minimum essential coverage. Other types of coverage, not statutorily 
designated and not designated as minimum essential coverage in 
regulation, may be recognized by the Secretary of Health and Human 
Services (HHS) as minimum essential coverage if certain substantive and 
procedural requirements are met. To be recognized as minimum essential 
coverage, the coverage must offer substantially the same consumer 
protections as those enumerated in the Title I of Affordable Care Act 
relating to non-grandfathered, individual health insurance coverage to 
ensure consumers are receiving adequate coverage. The final rule 
requires sponsors of other coverage that seek to have such coverage 
recognized as minimum essential coverage to adhere to certain 
procedures. Sponsoring organizations must submit to HHS certain 
information about their coverage and an attestation that the plan 
substantially complies with the provisions of Title I of the Affordable 
Care Act applicable to non-grandfathered individual health insurance 
coverage. Sponsors must also provide notice to enrollees informing

[[Page 64844]]

them that the plan has been recognized as minimum essential coverage 
for the purposes of the individual coverage requirement. Form Number: 
CMS-10465 (OMB control number: 0938-1189); Frequency: Occasionally; 
Affected Public: Public and Private sectors; Number of Respondents: 10; 
Total Annual Responses: 10; Total Annual Hours: 52.5. (For policy 
questions regarding this collection contact Russell Tipps at 301-492-
4371).

    Dated: December 13, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-27335 Filed 12-17-18; 8:45 am]
 BILLING CODE 4120-01-P
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