81 FR 26798 - Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 86 (May 4, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 86 (May 4, 2016)
| Page Range | 26798-26799 | |
| FR Document | 2016-10448 |
[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)] [Notices] [Pages 26798-26799] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10448] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10615] Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB) AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on an information collection concerning CMS' Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey. We are also announcing that the proposed information collection had been submitted to OMB and was approved under control number 0938-1300 through September 30, 2016. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA) we requested emergency review under 5 CFR 1320.13(a)(2)(i) because public harm is reasonably likely to result if the regular clearance procedures were followed. More specifically, the regular PRA clearance process would jeopardize the timely completion of CMS' evaluation of the State's upcoming non-emergency medical transportation (NEMT) waiver and other important waivers. Most importantly, it would potentially cause significant harm by depriving Medicaid beneficiaries--especially those affected by the NEMT waiver--of appropriate medical services and needed care. Although we have already received OMB approval to test/develop the survey instruments, we are now soliciting public comment for 30-days prior to implementing the survey in order to meet the conditions of OMB's Terms of Clearance that were issued on March 21, 2016. Under the PRA, federal agencies are required to publish notice in the Federal Register concerning each proposed information collection request (ICR). Interested persons are invited to send comments regarding our burden estimates or any other aspect of this ICR, including any of the following subjects: (1) The necessity and utility of the proposed ICR for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by June 3, 2016. ADDRESSES: When commenting, please reference the document identifier (CMS-10615) or OMB control number (0938-1300). To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for ``Comment or Submission'' or ``More Search Options'' to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: CMS-10615/OMB Control Number 0938-1300, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786- 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following ICR. More detailed information can be found in the collection's supporting statement and associated materials (see ADDRESSES). CMS-10615 Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey 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. In compliance with the requirement of section 3506(c)(2)(A) of the PRA, we submitted to OMB our request for emergency processing of this information collection. OMB approved the emergency ICR for testing/developing the survey on March 21, 2016. This iteration seeks emergency approval for fielding the survey and for conducting interviews and focus groups. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey; Use: This is a request for emergency approval to field the surveys and to conduct key informant interviews and focus groups. The surveys were tested during the first week of April 2016, and [[Page 26799]] there was a week-long public comment period that was announced in the Federal Register on March 29, 2016 (81 FR 17460). This ICR contains the revised surveys based on testing and public comments provided during the survey testing period. Emergency OMB approval is being sought, as permitted under 5 CPR 1320.13(a)(2)(i), since public harm is reasonably likely to occur if the regular nonemergency PRA clearance procedures are followed. Potential harm may result due to insufficient information to adequately support decision making that is required in November 2016. The clearance is particularly important for decisions about the renewal of precedent-setting waivers of Medicaid policy that assure important beneficiary protections regarding coverage and access to care; e.g., the NEMT waiver. That waiver ends or will be extended by no later than December 1, 2016. The survey effort is critical to supply more detail and information on HIP 2.0 beneficiary understanding and experiences (current and new enrollees as well as disenrollees/lockouts). Other information on other key policies under the Indiana HIP 2.0 demonstration, such as the 60 day beneficiary lock-out period, is also included in this information collection. Including this other information, as well as the interviews and focus groups, with the NEMT related information allows all this information to be collected during the same period of time; this will improve the efficiency of resources when compared to fielding separate surveys, interviews and focus groups at a later time which would be needed under the regular PRA process. Form Number: CMS-10615 (OMB control number: 0938-1300); Frequency: Once; Affected Public: Individuals and households, Private sector (Business or other for-profits and Not-for-profits institutions), and State, Local, or Tribal Governments; Number of Respondents: 5,240; Total Annual Responses: 5,240; Total Annual Hours: 1,442. (For policy questions regarding this collection contact Teresa DeCaro at 202-384- 6309). Written comments and recommendations will be considered from the public if received by the date and address noted above. Dated: April 29, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-10448 Filed 5-3-16; 8:45 am] BILLING CODE 4120-01-P
![26798 Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices
qualifications of the candidate from been submitted to OMB and was Operations and Regulatory Affairs,
person(s) not employed by the U.S. approved under control number 0938– Division of Regulations Development,
Department of Health and Human 1300 through September 30, 2016. In Attention: CMS–10615/OMB Control
Services. Candidates may submit accordance with the implementing Number 0938–1300, Room C4–26–05,
letter(s) from current HHS employees if regulations of the Paperwork Reduction 7500 Security Boulevard, Baltimore,
they wish, but at least one letter must Act of 1995 (PRA) we requested Maryland 21244–1850.
be submitted by a person not employed emergency review under 5 CFR To obtain copies of a supporting
by HHS. 1320.13(a)(2)(i) because public harm is statement and any related forms for the
Nominations should be submitted reasonably likely to result if the regular proposed collection(s) summarized in
(postmarked or received) by August 15, clearance procedures were followed. this notice, you may make your request
2016. More specifically, the regular PRA using one of following:
Electronic submissions: You may clearance process would jeopardize the 1. Access CMS’ Web site address at
submit nominations, including timely completion of CMS’ evaluation of http://www.cms.hhs.gov/
attachments, electronically to hicpac@ the State’s upcoming non-emergency PaperworkReductionActof1995.
cdc.gov. medical transportation (NEMT) waiver 2. Email your request, including your
Regular, Express or Overnight Mail: and other important waivers. Most address, phone number, OMB number,
Written nominations may be submitted importantly, it would potentially cause and CMS document identifier, to
to the following addressee only: Erin significant harm by depriving Medicaid Paperwork@cms.hhs.gov.
Stone, M.S., HICPAC, Division of beneficiaries—especially those affected 3. Call the Reports Clearance Office at
Healthcare Quality Promotion, NCEZID, by the NEMT waiver—of appropriate (410) 786–1326.
CDC, l600 Clifton Road NE., Mailstop medical services and needed care. FOR FURTHER INFORMATION CONTACT:
A–07, Atlanta, Georgia 30333. Although we have already received Reports Clearance Office at (410) 786–
Telephone and facsimile submissions OMB approval to test/develop the 1326.
cannot be accepted. Nominations may survey instruments, we are now
be submitted by the candidate or by the soliciting public comment for 30-days SUPPLEMENTARY INFORMATION:
person/organization recommending the prior to implementing the survey in Contents
candidate. order to meet the conditions of OMB’s
The Director, Management Analysis This notice sets out a summary of the
Terms of Clearance that were issued on
and Services Office, has been delegated use and burden associated with the
March 21, 2016.
the authority to sign Federal Register Under the PRA, federal agencies are following ICR. More detailed
notices pertaining to announcements of required to publish notice in the information can be found in the
meetings and other committee Federal Register concerning each collection’s supporting statement and
management activities, for both the proposed information collection request associated materials (see ADDRESSES).
Centers for Disease Control and (ICR). Interested persons are invited to CMS–10615 Healthy Indiana Program
Prevention and the Agency for Toxic send comments regarding our burden (HIP) 2.0 Beneficiaries Survey
Substances and Disease Registry. estimates or any other aspect of this ICR,
Under the PRA (44 U.S.C. 3501–
Catherine Ramadei, including any of the following subjects:
3520), federal agencies must obtain
Acting Director, Management Analysis and (1) The necessity and utility of the
approval from the Office of Management
Services Office, Centers for Disease Control proposed ICR for the proper
and Budget (OMB) for each collection of
and Prevention. performance of the agency’s functions;
information they conduct or sponsor.
[FR Doc. 2016–10423 Filed 5–3–16; 8:45 am] (2) the accuracy of the estimated
The term ‘‘collection of information’’ is
burden; (3) ways to enhance the quality,
BILLING CODE 4163–18–P defined in 44 U.S.C. 3502(3) and 5 CFR
utility, and clarity of the information to
1320.3(c) and includes agency requests
be collected; and (4) the use of
or requirements that members of the
DEPARTMENT OF HEALTH AND automated collection techniques or
public: Submit reports, keep records, or
HUMAN SERVICES other forms of information technology to
provide information to a third party. In
minimize the information collection
Centers for Medicare & Medicaid compliance with the requirement of
burden.
Services section 3506(c)(2)(A) of the PRA, we
DATES: Comments must be received by submitted to OMB our request for
[Document Identifier: CMS–10615] June 3, 2016. emergency processing of this
ADDRESSES: When commenting, please information collection. OMB approved
Emergency Clearance: Public reference the document identifier the emergency ICR for testing/
Information Collection Requirements (CMS–10615) or OMB control number developing the survey on March 21,
Submitted to the Office of Management (0938–1300). To be assured 2016. This iteration seeks emergency
and Budget (OMB) consideration, comments and approval for fielding the survey and for
AGENCY: Centers for Medicare & recommendations must be submitted in conducting interviews and focus groups.
Medicaid Services, Department of any one of the following ways:
1. Electronically. You may send your Information Collection
Health and Human Services.
ACTION: Notice. comments electronically to http:// 1. Type of Information Collection
www.regulations.gov. Follow the Request: Revision of a currently
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY: The Centers for Medicare & instructions for ‘‘Comment or approved collection; Title of
Medicaid Services (CMS) is announcing Submission’’ or ‘‘More Search Options’’ Information Collection: Healthy Indiana
an opportunity for the public to to find the information collection Program (HIP) 2.0 Beneficiaries Survey;
comment on an information collection document(s) that are accepting Use: This is a request for emergency
concerning CMS’ Healthy Indiana comments. approval to field the surveys and to
Program (HIP) 2.0 Beneficiaries Survey. 2. By regular mail. You may mail conduct key informant interviews and
We are also announcing that the written comments to the following focus groups. The surveys were tested
proposed information collection had address: CMS, Office of Strategic during the first week of April 2016, and
VerDate Sep<11>2014 18:44 May 03, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/81_FR_26884/page/1.svg)
![Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices 26799
there was a week-long public comment DEPARTMENT OF HEALTH AND • If you want to submit a comment
period that was announced in the HUMAN SERVICES with confidential information that you
Federal Register on March 29, 2016 (81 do not wish to be made available to the
FR 17460). This ICR contains the Food and Drug Administration public, submit the comment as a
revised surveys based on testing and written/paper submission and in the
public comments provided during the [Docket No. FDA–2016–D–1174] manner detailed (see ‘‘Written/Paper
survey testing period. Special Protocol Assessment; Draft Submissions’’ and ‘‘Instructions’’).
Emergency OMB approval is being
Guidance for Industry; Availability Written/Paper Submissions
sought, as permitted under 5 CPR
1320.13(a)(2)(i), since public harm is AGENCY: Food and Drug Administration, Submit written/paper submissions as
reasonably likely to occur if the regular HHS. follows:
nonemergency PRA clearance • Mail/Hand delivery/Courier (for
ACTION: Notice.
procedures are followed. Potential harm written/paper submissions): Division of
may result due to insufficient SUMMARY: The Food and Drug Dockets Management (HFA–305), Food
information to adequately support Administration (FDA or Agency) is and Drug Administration, 5630 Fishers
decision making that is required in announcing the availability of a draft Lane, Rm. 1061, Rockville, MD 20852.
November 2016. The clearance is guidance for industry entitled ‘‘Special • For written/paper comments
particularly important for decisions Protocol Assessment.’’ This draft submitted to the Division of Dockets
about the renewal of precedent-setting guidance provides information about Management, FDA will post your
waivers of Medicaid policy that assure the procedures and general policies comment, as well as any attachments,
important beneficiary protections adopted by the Center for Drug except for information submitted,
regarding coverage and access to care; Evaluation and Research (CDER) and the marked and identified, as confidential,
e.g., the NEMT waiver. That waiver Center for Biologics Evaluation and if submitted as detailed in
ends or will be extended by no later Research (CBER) for special protocol ‘‘Instructions.’’
Instructions: All submissions received
than December 1, 2016. The survey assessment (SPA). This draft guidance is
must include the Docket No. FDA–
effort is critical to supply more detail intended to improve the quality of
2016–D–1174 for ‘‘Special Protocol
and information on HIP 2.0 beneficiary Requests for SPAs and accompanying Assessment; Draft Guidance for
understanding and experiences (current submission materials, and the quality of Industry; Availability.’’ Received
and new enrollees as well as the resulting interaction between comments will be placed in the docket
disenrollees/lockouts). Other sponsors and FDA. This draft guidance and, except for those submitted as
information on other key policies under revises the guidance for industry ‘‘Confidential Submissions,’’ publicly
the Indiana HIP 2.0 demonstration, such entitled ‘‘Special Protocol Assessment’’ viewable at http://www.regulations.gov
as the 60 day beneficiary lock-out issued May 17, 2002. or at the Division of Dockets
period, is also included in this DATES: Although you can comment on Management between 9 a.m. and 4 p.m.,
information collection. Including this any guidance at any time (see 21 CFR Monday through Friday.
other information, as well as the 10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To
interviews and focus groups, with the considers your comment on this draft submit a comment with confidential
NEMT related information allows all guidance before it begins work on the information that you do not wish to be
this information to be collected during final version of the guidance, submit made publicly available, submit your
the same period of time; this will either electronic or written comments comments only as a written/paper
improve the efficiency of resources on the draft guidance by July 5, 2016. submission. You should submit two
when compared to fielding separate ADDRESSES: You may submit comments copies total. One copy will include the
surveys, interviews and focus groups at as follows: information you claim to be confidential
a later time which would be needed with a heading or cover note that states
under the regular PRA process. Form Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Number: CMS–10615 (OMB control Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
number: 0938–1300); Frequency: Once; following way: Agency will review this copy, including
Affected Public: Individuals and • Federal eRulemaking Portal: http:// the claimed confidential information, in
households, Private sector (Business or www.regulations.gov. Follow the its consideration of comments. The
other for-profits and Not-for-profits instructions for submitting comments. second copy, which will have the
institutions), and State, Local, or Tribal Comments submitted electronically, claimed confidential information
Governments; Number of Respondents: including attachments, to http:// redacted/blacked out, will be available
5,240; Total Annual Responses: 5,240; www.regulations.gov will be posted to for public viewing and posted on
Total Annual Hours: 1,442. (For policy the docket unchanged. Because your http://www.regulations.gov. Submit
questions regarding this collection comment will be made public, you are both copies to the Division of Dockets
contact Teresa DeCaro at 202–384– solely responsible for ensuring that your Management. If you do not wish your
6309). comment does not include any name and contact information to be
Written comments and confidential information that you or a made publicly available, you can
recommendations will be considered third party may not wish to be posted, provide this information on the cover
from the public if received by the date such as medical information, your or sheet and not in the body of your
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and address noted above. anyone else’s Social Security number, or comments and you must identify this
Dated: April 29, 2016. confidential business information, such information as ‘‘confidential.’’ Any
William N. Parham, III, as a manufacturing process. Please note information marked as ‘‘confidential’’
Director, Paperwork Reduction Staff, Office that if you include your name, contact will not be disclosed except in
of Strategic Operations and Regulatory information, or other information that accordance with 21 CFR 10.20 and other
Affairs. identifies you in the body of your applicable disclosure law. For more
[FR Doc. 2016–10448 Filed 5–3–16; 8:45 am] comments, that information will be information about FDA’s posting of
BILLING CODE 4120–01–P posted on http://www.regulations.gov. comments to public dockets, see 80 FR
VerDate Sep<11>2014 18:44 May 03, 2016 Jkt 238001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/81_FR_26884/page/2.svg)
Document Created: 2016-05-04 01:22:47
Document Modified: 2016-05-04 01:22:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by June 3, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 26798 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR