83 FR 32667 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 135 (July 13, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 135 (July 13, 2018)
| Page Range | 32667-32669 | |
| FR Document | 2018-15038 |
[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)] [Notices] [Pages 32667-32669] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15038] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10531, CMS-R-43, CMS-10102, CMS-10143, CMS- 10261, CMS-10500, and CMS-855I] 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 13, 2018. 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 http://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: Reports Clearance Office at (410) 786- 1326. 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 Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD); Use: The data collection is required by the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) entitled, ``Transcatheter Mitral Valve Repair (TMVR)''. The TMVR device is only covered when specific conditions are met including that the heart team and hospital are submitting data in a prospective, national, audited registry. The data includes patient, practitioner and facility level variables that predict outcomes such as all-cause mortality and quality of life. In order to remove the data collection requirement under this coverage with evidence development (CED) NCD or make any other changes to the existing policy, we [[Page 32668]] must formally reopen and reconsider the policy. We are continuing to review and analyze the data collected since this NCD was effective in 2014 We find that the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by the National Cardiovascular Data Registry, meets the requirements specified in the NCD on TMVR. The TVT Registry will support a national surveillance system to monitor the safety and efficacy of the TMVR technologies for the treatment of mitral regurgitation (MR). The data collected and analyzed in the TVT Registry will be used by CMS to determine if the TMVR is reasonable and necessary (e.g., improves health outcomes) for Medicare beneficiaries under section 1862(a)(1)(A) of the Act. The data will also include the variables on the eight item Kansas City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status, functioning and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptoms (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The conduct of the STS/ACC TVT Registry and the KCCQ-10 is pursuant to Section 1142 of the Social Security Act (the ACT) that describes the authority of the Agency for Healthcare Research and Quality (AHRQ). Under section 1142, research may be conducted and supported on the outcomes, effectiveness, and appropriateness of health care services and procedures to identify the manner in which disease, disorders, and other health conditions can be prevented, diagnosed, treated, and managed clinically. Section 1862(a)(1)(E) of the Act allows Medicare to cover under coverage with evidence development (CED) certain items or services for which the evidence is not adequate to support coverage under section 1862(a)(1)(A) and where additional data gathered in the context of a clinical setting would further clarify the impact of these items and services on the health of beneficiaries. Form Number: CMS- 10531 (OMB control number: 0938-1274); Frequency: Annually; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 3,897; Total Annual Responses: 15,588; Total Annual Hours: 5,456. (For policy questions regarding this collection contact Sarah Fulton at 410-786-2749.) 2. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Conditions of Coverage for Portable X-ray Suppliers and Supporting Regulations; Use: The requirements contained in this information collection request are classified as conditions of participation or conditions for coverage. Portable X-rays are basic radiology studies (predominately chest and extremity X-rays) performed on patients in skilled nursing facilities, residents of long-term care facilities and homebound patients. The CoPs are based on criteria described in the law, and are designed to ensure that each portable X- ray supplier has properly trained staff and provides the appropriate type and level of care for patients. We use these conditions to certify suppliers of portable X-ray services wishing to participate in the Medicare program. This is standard medical practice and is necessary in order to help to ensure the well-being, safety and quality professional medical treatment accountability for each patient. There is a significant increase in the burden due to burden that was not accounted for in the previous information collection request. Form Number: CMS-R- 43 (OMB Control number: 0938-0338); Frequency: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 5,986,509; Total Annual Responses: 5,987,018; Total Annual Hours: 532,959. (For policy questions regarding this collections contact Sonia Swancy at 410-786-8445.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: National Implementation of the Hospital CAHPS Survey; Use: The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey, also known as the CAHPS[supreg] Hospital Survey or Hospital CAHPS[supreg], is a standardized survey instrument and data collection methodology that has been in use since 2006 to measure patients' perspectives of hospital care. While many hospitals collect information on patient satisfaction, HCAHPS created a national standard for the collection and public reporting of information that enables valid comparisons to be made across all hospitals to support consumer choice. Form Number: CMS- 10102 (OMB control number 0938-0981); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for- profit institutions); Number of Respondents: 4,200; Total Annual Responses: 3,100,000; Total Annual Hours: 413,230. (For policy questions regarding this collection contact William Lehrman at 410-786- 1037.) 4. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: State Data for the Medicare Modernization Act (MMA); Use: The monthly data file is provided to CMS by states on dual eligible beneficiaries. The phase- down process requires a monthly count of all full benefit dual eligible beneficiaries with an active Part D plan enrollment in the month. CMS will make this selection of records using dual eligibility status codes contained in the person-month record to identify all full-benefit dual eligible beneficiaries (codes 02, 04 and 08). In the case where in a given month, multiple records were submitted for the same beneficiary in multiple file submittals, the last record submitted for that beneficiary shall be used to determine the final effect on the phase- down count. Form Number: CMS-10143 (OMB Control Number: 0938-0958); Frequency: Monthly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 612; Total Annual Hours: 4,896. (For policy questions regarding this collection contact Linda King at 410-786-1312.) 5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a); Use: Medicare Advantage Organizations (MAOs) must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, and while safeguarding the confidentiality of the doctor-patient relationship, statistics and other information with respect to: The cost of its operations; the patterns of service utilization; the availability, accessibility, and acceptability of its services; to the extent practical, developments in the health status of its enrollees; information demonstrating that the MAO has a fiscally sound operation; and other matters that CMS may require. CMS also has oversight authority over cost plans which includes establishment of reporting requirements. The changes for the 2019 reporting requirements under Organization Determinations and Reconsiderations (ODR) will add 18 new data elements to the reporting section. The new data elements will [[Page 32669]] allow CMS to obtain more information about who is submitting requests for ODR and whether the service or claim is being provided by a contract or non-contract provider. The timeliness requirement for ODR will also be eliminated to be consistent with Part D reporting. In addition, the number of data reporting elements of grievances is reduced from 23 to 19. The reporting sections for Private Fee For Service (PFFS) Payment Dispute Resolution Process and Mid-Year Network Changes will also be suspended. Form Number: CMS-10261 (OMB control number: 0938-1054); Frequency: Yearly and semi-annually; Affected Public: Private sector (business or other for-profits); Number of Respondents: 432; Total Annual Responses: 3,024; Total Annual Hours: 127,329. (For policy questions regarding this collection contact Maria Sotirelis at 410-786-0552.) 6. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Consumer Assessment of Healthcare Providers and Systems Outpatient and Ambulatory Surgery (OAS CAHPS) Survey; Use: The information collected in the national implementation of Outpatient/Ambulatory Surgery Patient Experience of Care Survey (A/ASPECS) will be used to: (1) Provide a source of information from which selected measures can be publicly reported to beneficiaries to help them make informed decisions for outpatient surgery facility selection; (2) aid facilities with their internal quality improvement efforts and external benchmarking with other facilities; and (3) provide us with information for monitoring and public reporting purposes. Form Number: CMS-10500 (OMB control number: 0938-1240); Frequency: Once; Affected Public: Individuals and households; Number of Respondents: 633,304; Total Annual Responses: 633,304; Total Annual Hours: 153,592. (For policy questions regarding this collection contact Memuna Ifedirah at 410-786-6849). 7. Type of Information Collection Request: New collection (Request for new OMB control number); Title of Information Collection: Medicare Enrollment Application for Physician and Non-Physician Practitioners; Use: The application is used by Medicare contractors to collect data to ensure that the applicant has the necessary credentials to provide the health care services for which they intend to bill Medicare, including information that allows the Medicare contractor to correctly price, process and pay the applicant's claims. This application collects information to ensure that only legitimate physicians, non-physician practitioners, and other eligible professionals are enrolled in the Medicare program. It is meant to be the first line defense to protect our beneficiaries from illegitimate providers and to protect the Medicare Trust Fund against fraud. It also gathers information that allows Medicare contractors to ensure that the provider/supplier is not sanctioned from the Medicare and/or Medicaid program(s), or debarred, suspended or excluded from any other Federal agency or program. Form Number: CMS-855i (OMB control number: 0938-NEW); Frequency: On Occasion; Affected Public: State, Local, or Tribal Governments, Private Sector (not-for-profit institutions); Number of Respondents: 513,872; Total Annual Responses: 1,370,078; Total Annual Hours: 1,000,167. For policy questions regarding this collection contact Kimberly McPhillips at (410)-786-5374. Dated: July 10, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-15038 Filed 7-12-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 32667
recommended level. Further, the issues Dated: July 9, 2018. Email: OIRA_submission@
of whether or not to adjust fluoride in Sandra Cashman, omb.eop.gov
drinking water, as well as the Executive Secretary, Centers for Disease To obtain copies of a supporting
recommended level to which fluoride Control and Prevention. statement and any related forms for the
should be adjusted, have previously [FR Doc. 2018–14968 Filed 7–12–18; 8:45 am] proposed collection(s) summarized in
been addressed in the Federal Register BILLING CODE 4163–18–P this notice, you may make your request
and are not part of this request.8 using one of following:
Note: Public water systems must 1. Access CMS’ website address at
continue to comply with Environmental DEPARTMENT OF HEALTH AND http://www.cms.hhs.gov/Paperwork
Protection Agency (EPA) requirements HUMAN SERVICES ReductionActof1995.
2. Email your request, including your
for a special notice for exceedance of the
Centers for Medicare & Medicaid address, phone number, OMB number,
secondary standard of 2 mg/L (40 CFR
Services and CMS document identifier, to
141.208) (https://www.epa.gov/
Paperwork@cms.hhs.gov.
dwregdev/drinking-water-regulations- [Document Identifiers: CMS–10531, CMS– 3. Call the Reports Clearance Office at
and-contaminants). R–43, CMS–10102, CMS–10143, CMS–10261, (410) 786–1326.
CDC is seeking public comment on CMS–10500, and CMS–855I]
FOR FURTHER INFORMATION CONTACT:
the following: Reports Clearance Office at (410) 786–
Agency Information Collection
1. Are there any evidence-based Activities: Submission for OMB 1326.
concerns about the appropriateness of Review; Comment Request SUPPLEMENTARY INFORMATION: Under the
the proposed operational control range Paperwork Reduction Act of 1995 (PRA)
and criteria for adherence based on AGENCY: Centers for Medicare &
Medicaid Services, HHS. (44 U.S.C. 3501–3520), federal agencies
measurement capacity or feasibility of must obtain approval from the Office of
maintaining the target level? ACTION: Notice.
Management and Budget (OMB) for each
References SUMMARY: The Centers for Medicare & collection of information they conduct
1. U.S. Public Health Service Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of
an opportunity for the public to information’’ is defined in 44 U.S.C.
Recommendations for Fluoride
Concentration in Drinking Water for the comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and
Prevention of Dental Caries. Public information from the public. Under the includes agency requests or
Health Reports. 2015 July– Paperwork Reduction Act of 1995 requirements that members of the public
Aug;130(4):318–331. (PRA), federal agencies are required to submit reports, keep records, or provide
2. Department of Health, Education and publish notice in the Federal Register information to a third party. Section
Welfare (US) Public Health Service 3506(c)(2)(A) of the PRA (44 U.S.C.
drinking water standards, revised 1962.
concerning each proposed collection of
information, including each proposed 3506(c)(2)(A)) requires federal agencies
Washington: Public Health Service (US);
1962. PHS Publication No. 956. extension or reinstatement of an existing to publish a 30-day notice in the
collection of information, and to allow Federal Register concerning each
3. Barker LK, Duchon KK, Lesaja S, et al.
Adjusted Fluoride Concentrations in 34 a second opportunity for public proposed collection of information,
States: 2006–2010 and 2015. Journal comment on the notice. Interested including each proposed extension or
AWWA. 2017;109(8):2–17. persons are invited to send comments reinstatement of an existing collection
4. Engineering and Administrative regarding the burden estimate or any of information, before submitting the
Recommendations for Water other aspect of this collection of collection to OMB for approval. To
Fluoridation, MMWR Sept 29,1995/
44(RR–13:1–40. Fluoride
information, including the necessity and comply with this requirement, CMS is
utility of the proposed information publishing this notice that summarizes
Recommendations Work Group.
Recommendations for using fluoride to collection for the proper performance of the following proposed collection(s) of
the agency’s functions, the accuracy of information for public comment:
prevent and control dental caries in the
United States. MMWR Recomm Rep. the estimated burden, ways to enhance 1. Type of Information Collection
2001;50(RR–14):1–42. the quality, utility, and clarity of the Request: Reinstatement with change of a
5. Heller KE, Eklund SA, Burt BA. Dental information to be collected and the use previously approved collection; Title of
caries and dental fluorosis at varying of automated collection techniques or Information Collection: Transcatheter
water fluoride concentrations. J Public other forms of information technology to Mitral Valve Repair (TMVR) National
Health Dent. 1997;57:136–43. Coverage Decision (NCD); Use: The data
6. Brown R, McTigue N, Graf K. Monitoring
minimize the information collection
burden. collection is required by the Centers for
fluoride: how closely do utilities match Medicare and Medicaid Services (CMS)
target versus actual levels? Opflow, DATES: Comments on the collection(s) of National Coverage Determination (NCD)
40;7:10. https://doi.org/10.5991/ information must be received by the
OPF.2014.40.0042.
entitled, ‘‘Transcatheter Mitral Valve
OMB desk officer by August 13, 2018. Repair (TMVR)’’. The TMVR device is
7. Teefy S. Managing fluoridation within a
stringent regulatory framework. Proc ADDRESSES: When commenting on the only covered when specific conditions
2013 AWWA Water Quality Technology proposed information collections, are met including that the heart team
Conference, Oakland, Calif. please reference the document identifier and hospital are submitting data in a
8. Public Health Service Recommendation for or OMB control number. To be assured prospective, national, audited registry.
Fluoride Concentration in Drinking consideration, comments and The data includes patient, practitioner
sradovich on DSK3GMQ082PROD with NOTICES
Water for the Prevention of Dental recommendations must be received by and facility level variables that predict
Caries. Fed Regist. 2015;80(84):24936– the OMB desk officer via one of the outcomes such as all-cause mortality
24947. Available at: https://
www.federalregister.gov/documents/
following transmissions: and quality of life. In order to remove
2015/05/01/2015-10201/public-health- OMB, Office of Information and the data collection requirement under
service-recommendation-for-fluoride- Regulatory Affairs this coverage with evidence
concentration-in-drinking-water-for- Attention: CMS Desk Officer development (CED) NCD or make any
prevention-of. Accessed 5/11/2018. Fax Number: (202) 395–5806 OR other changes to the existing policy, we
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![Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 32669
allow CMS to obtain more information legitimate physicians, non-physician in the PDE for cadmium by the
about who is submitting requests for practitioners, and other eligible inhalation route of exposure. Following
ODR and whether the service or claim professionals are enrolled in the deliberations within the Q3D Expert
is being provided by a contract or non- Medicare program. It is meant to be the Working Group, the revised calculation
contract provider. The timeliness first line defense to protect our is based on a modifying factor approach
requirement for ODR will also be beneficiaries from illegitimate providers that is consistent with the oral and
eliminated to be consistent with Part D and to protect the Medicare Trust Fund parenteral PDE calculations.
reporting. In addition, the number of against fraud. It also gathers information DATES: Submit either electronic or
data reporting elements of grievances is that allows Medicare contractors to written comments on the draft guidance
reduced from 23 to 19. The reporting ensure that the provider/supplier is not by August 13, 2018 to ensure that the
sections for Private Fee For Service sanctioned from the Medicare and/or Agency considers your comment on this
(PFFS) Payment Dispute Resolution Medicaid program(s), or debarred, draft guidance before it begins work on
Process and Mid-Year Network Changes suspended or excluded from any other the final version of the guidance.
will also be suspended. Form Number: Federal agency or program. Form
ADDRESSES: You may submit comments
CMS–10261 (OMB control number: Number: CMS–855i (OMB control
on any guidance at any time as follows:
0938–1054); Frequency: Yearly and number: 0938–NEW); Frequency: On
semi-annually; Affected Public: Private Occasion; Affected Public: State, Local, Electronic Submissions
sector (business or other for-profits); or Tribal Governments, Private Sector
Submit electronic comments in the
Number of Respondents: 432; Total (not-for-profit institutions); Number of
following way:
Annual Responses: 3,024; Total Annual Respondents: 513,872; Total Annual
• Federal eRulemaking Portal:
Hours: 127,329. (For policy questions Responses: 1,370,078; Total Annual
https://www.regulations.gov. Follow the
regarding this collection contact Maria Hours: 1,000,167. For policy questions
instructions for submitting comments.
Sotirelis at 410–786–0552.) regarding this collection contact
6. Type of Information Collection Comments submitted electronically,
Kimberly McPhillips at (410)-786–5374.
Request: Revision of a currently including attachments, to https://
Dated: July 10, 2018. www.regulations.gov will be posted to
approved collection; Title of
William N. Parham, III, the docket unchanged. Because your
Information Collection: Consumer
Director, Paperwork Reduction Staff, Office comment will be made public, you are
Assessment of Healthcare Providers and of Strategic Operations and Regulatory
Systems Outpatient and Ambulatory solely responsible for ensuring that your
Affairs. comment does not include any
Surgery (OAS CAHPS) Survey; Use: The
[FR Doc. 2018–15038 Filed 7–12–18; 8:45 am] confidential information that you or a
information collected in the national
implementation of Outpatient/ BILLING CODE 4120–01–P third party may not wish to be posted,
Ambulatory Surgery Patient Experience such as medical information, your or
of Care Survey (A/ASPECS) will be used anyone else’s Social Security number, or
DEPARTMENT OF HEALTH AND confidential business information, such
to: (1) Provide a source of information HUMAN SERVICES
from which selected measures can be as a manufacturing process. Please note
publicly reported to beneficiaries to that if you include your name, contact
Food and Drug Administration
help them make informed decisions for information, or other information that
outpatient surgery facility selection; (2) [Docket No. FDA–2013–D–1156] identifies you in the body of your
aid facilities with their internal quality comments, that information will be
Q3D(R1) Elemental Impurities; posted on https://www.regulations.gov.
improvement efforts and external International Council for
benchmarking with other facilities; and • If you want to submit a comment
Harmonisation; Draft Guidance for with confidential information that you
(3) provide us with information for Industry; Availability
monitoring and public reporting do not wish to be made available to the
purposes. Form Number: CMS–10500 AGENCY: Food and Drug Administration, public, submit the comment as a
(OMB control number: 0938–1240); HHS. written/paper submission and in the
Frequency: Once; Affected Public: ACTION: Notice of availability. manner detailed (see ‘‘Written/Paper
Individuals and households; Number of Submissions’’ and ‘‘Instructions’’).
Respondents: 633,304; Total Annual SUMMARY: The Food and Drug
Administration (FDA or Agency) is Written/Paper Submissions
Responses: 633,304; Total Annual
Hours: 153,592. (For policy questions announcing the availability of a draft Submit written/paper submissions as
regarding this collection contact guidance for industry entitled ‘‘Q3D(R1) follows:
Memuna Ifedirah at 410–786–6849). Elemental Impurities.’’ The draft • Mail/Hand delivery/Courier (for
7. Type of Information Collection guidance was prepared under the written/paper submissions): Dockets
Request: New collection (Request for auspices of the International Council for Management Staff (HFA–305), Food and
new OMB control number); Title of Harmonisation (ICH), formerly the Drug Administration, 5630 Fishers
Information Collection: Medicare International Conference on Lane, Rm. 1061, Rockville, MD 20852.
Enrollment Application for Physician Harmonisation. The draft guidance • For written/paper comments
and Non-Physician Practitioners; Use: revises the existing ICH guidance for submitted to the Dockets Management
The application is used by Medicare industry ‘‘Q3D Elemental Impurities’’ Staff, FDA will post your comment, as
contractors to collect data to ensure that and provides an updated permitted well as any attachments, except for
daily exposure (PDE) for the cadmium information submitted, marked and
sradovich on DSK3GMQ082PROD with NOTICES
the applicant has the necessary
credentials to provide the health care inhalation route of exposure. The identified, as confidential, if submitted
services for which they intend to bill updated PDE of 3 micrograms (mg)/day as detailed in ‘‘Instructions.’’
Medicare, including information that is based on a modifying factor approach Instructions: All submissions received
allows the Medicare contractor to like that used for calculating the PDEs must include the Docket No. FDA–
correctly price, process and pay the for the cadmium oral and parenteral 2013–D–1156 for ‘‘Q3D(R1) Elemental
applicant’s claims. This application routes of exposure. The draft guidance Impurities.’’ Received comments will be
collects information to ensure that only is intended to correct a calculation error placed in the docket and, except for
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Document Created: 2018-07-13 01:04:20
Document Modified: 2018-07-13 01:04:20
| 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 on the collection(s) of information must be received by the OMB desk officer by August 13, 2018. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 83 FR 32667 |
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