81 FR 16184 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 58 (March 25, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 58 (March 25, 2016)
| Page Range | 16184-16186 | |
| FR Document | 2016-06830 |
[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)] [Notices] [Pages 16184-16186] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06830] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-855O, CMS-10438, CMS-10439 and CMS-10440] Agency Information Collection Activities: Submission for OMB Review; Comment Request 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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to [[Page 16185]] 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 on the collection(s) of information must be received by the OMB desk officer by April 25, 2016. 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_[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' 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: 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: Revision of a currently approved information collection; Title of Information Collection: Medicare Registration Application; Use: The primary function of the CMS-855O is to gather information from a physician or other eligible professional to help CMS determine whether he or she meets certain qualifications to be enrolled in the Medicare program for the sole purpose of ordering or certifying certain Medicare items or services and/or prescribing Medicare Part D drugs for Medicare beneficiaries. The application allows a physician or other eligible professional to enroll in Medicare without being approved for billing privileges. The required information is submitted when the applicant requests enrollment in Medicare for the sole purpose of ordering and certifying certain Medicare items and services or for prescribing Medicare Part D drugs. The application is used by Medicare contractors to collect data to help ensure that the applicant has the necessary credentials to order and certify certain Medicare items and services or to prescribe Medicare Part D drugs. This includes ensuring that the physician is not excluded debarred from the Medicare program. Form Number: CMS-855O (OMB control number: 0938-1135); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profits), State, Local, or Tribal Governments; Number of Respondents: 448,000; Number of Responses: 24,000; Total Annual Hours: 243,600. (For questions regarding this collection contact Kimberly McPhillips (410) 786-8438.) 2. Type of Information Collection Request: Revision of a currently approved information collection; Title of Information Collection: Data Collection to Support Eligibility Determinations and Enrollment for Employers in the Small Business Health Options Program; Use: Section 1311(b)(1)(B) of the Affordable Care Act directs that the SHOP assist qualified small employers in facilitating the enrollment of their employees in QHPs offered in the small group market. Section 1311(c)(1)(F) of the Affordable Care Act directs HHS to establish criteria for certification of health plans as QHPs and plans to utilize a uniform enrollment form for qualified employers. Further, section 1311(c)(5)(B) directs HHS to develop a Web site that assists employers in determining if they are eligible to participate in SHOP. This proposed information collection was previously published in the Federal Register on December 11, 2015 (80 FR 76994) and allowed 60 days for public comment. No comments were received. Form Number: CMS- 10439 (OMB control number 0938-1194); Frequency: Annually; Affected Public: Private Sector; Number of Respondents: 6,000; Number of Responses: 6,000; Total Annual Hours: 12,000. (For questions regarding this collection contact Christelle Jang at (410) 786-8438.) 3. Type of Information Collection Request: Revision of a currently approved information collection; Title of Information Collection: Data Collection to Support Eligibility Determinations and Enrollment for Employers in the Small Business Health Options Program; Use: Section 1311(b)(1)(B) of the Affordable Care Act directs that the SHOP assist qualified small employers in facilitating the enrollment of their employees in QHPs offered in the small group market. Section 1311(c)(1)(F) of the Affordable Care Act directs HHS to establish criteria for certification of health plans as QHPs and plans to utilize a uniform enrollment form for qualified employers. Further, section 1311(c)(5)(B) directs HHS to develop a Web site that assists employers in determining if they are eligible to participate in SHOP. This proposed information collection was previously published in the Federal Register on December 11, 2015 (80 FR 76994) and allowed 60 days for public comment. No comments were received. Form Number: CMS- 10439 (OMB Control Number 0938-1194); Frequency: Annually; Affected Public: Private Sector; Number of Respondents: 6,000; Number of Responses: 6,000; Total Annual Hours: 12,000. (For questions regarding this collection contact Christelle Jang at (410) 786-8438.) 4. Type of Information Collection Request: Revision of a currently approved information collection; Title of Information Collection: Data Collection to Support Eligibility Determinations for Insurance Affordability Programs and Enrollment through Health Benefits Exchanges, Medicaid and Children's Health Insurance Program Agencies; Use: Section 1413 of the Affordable Care Act directs the Secretary of Health and Human Services to develop and provide to each State a single, streamlined form that may be used to apply for coverage through the Exchange and Insurance Affordability Programs, including Medicaid, the Children's Health Insurance Program (CHIP), and the Basic Health Program, as applicable. The application must be structured to maximize an applicant's ability to complete the form satisfactorily, taking into account the characteristics of individuals who qualify for the programs. A State may develop and use its own single streamlined application if [[Page 16186]] approved by the Secretary in accordance with section 1413 and if it meets the standards established by the Secretary. Section 155.405(a) of the Exchange Final Rule (77 FR 18310) provides more detail about the application that must be used by the Exchange to determine eligibility and to collect information necessary for enrollment. The regulations in Sec. 435.907 and Sec. 457.330 establish the requirements for State Medicaid and CHIP agencies related to the use of the single streamlined application. CMS is designing the single streamlined application to be a dynamic electronic application that will tailor the amount of data required from an applicant based on the applicant's circumstances and responses to particular questions. The paper version of the application will not be able to be tailored in the same way but is being designed to collect only the data required to determine eligibility. Individuals will be able to submit an application electronically, through the mail, over the phone through a call center, or in person, per Sec. 155.405(c)(2) of the Exchange Final Rule, as well as through other commonly available electronic means as noted in Sec. 435.907(a) and Sec. 457.330 of the Medicaid Final Rule. The application may be submitted to an Exchange, Medicaid or CHIP agency. The electronic application process will vary depending on each applicant's circumstances, their experience with health insurance applications and online capabilities. The goal is to solicit sufficient information so that in most cases no further inquiry will be needed. Form Number: CMS-10440 (OMB control number: 0938-1191); Frequency: Annually; Affected Public: Individuals and Households; Number of Respondents: 7,200,000; Total Annual Responses: 7,200,000; Total Annual Hours: 2,410,767. (For policy questions regarding this collection contact Beth Liu at 301-492-4135.) Dated: March 22, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-06830 Filed 3-24-16; 8:45 am] BILLING CODE 4120-01-P
![16184 Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices
DEPARTMENT OF HEALTH AND To obtain copies of a supporting collected in this survey can be used to
HUMAN SERVICES statement and any related forms for the improve the operation of Medicare
proposed collection(s) summarized in Advantage (MA) (both MA and MA–PD)
Centers for Medicare & Medicaid this notice, you may make your request contracts and standalone prescription
Services using one of following: drug plans (PDPs) through the
[Document Identifier: CMS–10316] 1. Access CMS’ Web site address at identification of beneficiary
http://www.cms.hhs.gov/Paperwork disenrollment reasons. Plans can use the
Agency Information Collection ReductionActof1995. information to guide quality
Activities: Proposed Collection; 2. Email your request, including your improvement efforts. The data can also
Comment Request address, phone number, OMB number, be used by beneficiaries who need to
and CMS document identifier, to choose among the different MA and PDP
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. options. To the extent that these data
Medicaid Services. 3. Call the Reports Clearance Office at identify areas for improvement at the
ACTION: Notice. (410) 786–1326. contract level they can be used for
FOR FURTHER INFORMATION CONTACT: contract oversight. Form Number: CMS–
SUMMARY: The Centers for Medicare &
Reports Clearance Office at (410) 786– 10316 (OMB control number: 0938–
Medicaid Services (CMS) is announcing
1326. 1113); Frequency: Yearly; Affected
an opportunity for the public to
Public: Individuals or households;
comment on CMS’ intention to collect SUPPLEMENTARY INFORMATION: Number of Respondents: 56,972; Total
information from the public. Under the
Contents Annual Responses: 56,972; Total
Paperwork Reduction Act of 1995 (the
Annual Hours: 15,032. (For policy
PRA), federal agencies are require; to This notice sets out a summary of the questions regarding this collection
publish notice in the Federal Register use and burden associated with the contact Beth Simon at 415–744–3780.)
concerning each proposed collection of following information collections. More
information (including each proposed detailed information can be found in Dated: March 22, 2016.
extension or reinstatement of an existing each collection’s supporting statement William N. Parham, III,
collection of information) and to allow and associated materials (see Director, Paperwork Reduction Staff, Office
60 days for public comment on the ADDRESSES). of Strategic Operations and Regulatory
proposed action. Interested persons are Affairs.
invited to send comments regarding our CMS–10316 Implementation of the [FR Doc. 2016–06829 Filed 3–24–16; 8:45 am]
burden estimates or any other aspect of Medicare Prescription Drug Plan (PDP) BILLING CODE 4120–01–P
this collection of information, including and Medicare Advantage (MA) Plan
any of the following subjects: (1) The Disenrollment Reasons Survey
necessity and utility of the proposed Under the PRA (44 U.S.C. 3501– DEPARTMENT OF HEALTH AND
information collection for the proper 3520), federal agencies must obtain HUMAN SERVICES
performance of the agency’s functions; approval from the Office of Management
(2) the accuracy of the estimated Centers for Medicare & Medicaid
and Budget (OMB) for each collection of
burden; (3) ways to enhance the quality, Services
information they conduct or sponsor.
utility, and clarity of the information to The term ‘‘collection of information’’ is [Document Identifiers: CMS–855O, CMS–
be collected; and (4) the use of defined in 44 U.S.C. 3502(3) and 5 CFR 10438, CMS–10439 and CMS–10440]
automated collection techniques or 1320.3(c) and includes agency requests
other forms of information technology to or requirements that members of the Agency Information Collection
minimize the information collection public submit reports, keep records, or Activities: Submission for OMB
burden. provide information to a third party. Review; Comment Request
DATES: Comments must be received by Section 3506(c)(2)(A) of the PRA ACTION: Notice.
May 24, 2016. requires federal agencies to publish a
ADDRESSES: When commenting, please 60-day notice in the Federal Register SUMMARY: The Centers for Medicare &
reference the document identifier or concerning each proposed collection of Medicaid Services (CMS) is announcing
OMB control number. To be assured information, including each proposed an opportunity for the public to
consideration, comments and extension or reinstatement of an existing comment on CMS’ intention to collect
recommendations must be submitted in collection of information, before information from the public. Under the
any one of the following ways: submitting the collection to OMB for Paperwork Reduction Act of 1995
1. Electronically. You may send your approval. To comply with this (PRA), federal agencies are required to
comments electronically to http:// requirement, CMS is publishing this publish notice in the Federal Register
www.regulations.gov. Follow the notice. concerning each proposed collection of
instructions for ‘‘Comment or 1. Type of Information Collection information, including each proposed
Submission’’ or ‘‘More Search Options’’ Request: Revision of a currently extension or reinstatement of an existing
to find the information collection approved collection; Title of collection of information, and to allow
document(s) that are accepting Information Collection: Implementation a second opportunity for public
comments. of the Medicare Prescription Drug Plan comment on the notice. Interested
2. By regular mail. You may mail (PDP) and Medicare Advantage (MA) persons are invited to send comments
asabaliauskas on DSK3SPTVN1PROD with NOTICES
written comments to the following Plan Disenrollment Reasons Survey; regarding the burden estimate or any
address: CMS, Office of Strategic Use: This data collection complements other aspect of this collection of
Operations and Regulatory Affairs, the satisfaction data collected through information, including any of the
Division of Regulations Development, the Medicare Consumer Assessment of following subjects: (1) The necessity and
Attention: Document Identifier/OMB Healthcare Providers and Systems utility of the proposed information
Control Number llll, Room C4–26– survey by providing dissatisfaction data collection for the proper performance of
05, 7500 Security Boulevard, Baltimore, in the form of reasons for disenrollment the agency’s functions; (2) the accuracy
Maryland 21244–1850. from a Prescription Drug Plan. The data of the estimated burden; (3) ways to
VerDate Sep<11>2014 18:30 Mar 24, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1](https://thefederalregister.org/doc/81_FR_16242/page/1.svg)
![16186 Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices
approved by the Secretary in accordance DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
with section 1413 and if it meets the HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
standards established by the Secretary. Written/Paper Submissions
Food and Drug Administration
Section 155.405(a) of the Exchange Submit written/paper submissions as
Final Rule (77 FR 18310) provides more [Docket No. FDA–2016–D–0785] follows:
detail about the application that must be • Mail/Hand delivery/Courier (for
used by the Exchange to determine General Principles for Evaluating the written/paper submissions): Division of
eligibility and to collect information Abuse Deterrence of Generic Solid Dockets Management (HFA–305), Food
necessary for enrollment. The Oral Opioid Drugs Products; Draft and Drug Administration, 5630 Fishers
regulations in § 435.907 and § 457.330 Guidance for Industry; Availability Lane, Rm. 1061, Rockville, MD 20852.
establish the requirements for State AGENCY: Food and Drug Administration, • For written/paper comments
Medicaid and CHIP agencies related to HHS. submitted to the Division of Dockets
the use of the single streamlined Management, FDA will post your
ACTION: Notice of availability. comment, as well as any attachments,
application. CMS is designing the single
streamlined application to be a dynamic SUMMARY: The Food and Drug except for information submitted,
electronic application that will tailor the Administration (FDA) is announcing the marked and identified, as confidential,
amount of data required from an availability of a draft guidance for if submitted as detailed in
industry entitled ‘‘General Principles for ‘‘Instructions.’’
applicant based on the applicant’s
Instructions: All submissions received
circumstances and responses to Evaluating the Abuse Deterrence of
must include the Docket No. FDA–
particular questions. The paper version Generic Solid Oral Opioid Drug
2016–D–0785 for ‘‘General Principles
of the application will not be able to be Products.’’ This draft guidance
for Evaluating the Abuse-Deterrence of
tailored in the same way but is being recommends studies, including
Generic Solid Oral Opioid Drugs.’’
designed to collect only the data comparative in vitro studies, which
Received comments will be placed in
required to determine eligibility. should be conducted to demonstrate
the docket and, except for those
Individuals will be able to submit an that a proposed generic solid oral opioid
submitted as ‘‘Confidential
application electronically, through the drug product is no less abuse-deterrent Submissions,’’ publicly viewable at
mail, over the phone through a call than its reference listed drug. http://www.regulations.gov or at the
center, or in person, per § 155.405(c)(2) DATES: Although you can comment on Division of Dockets Management
of the Exchange Final Rule, as well as any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday
through other commonly available 10.115(g)(5)), to ensure that the Agency through Friday.
electronic means as noted in considers your comment on this draft • Confidential Submissions—To
§ 435.907(a) and § 457.330 of the guidance before it begins work on the submit a comment with confidential
final version of the guidance, submit information that you do not wish to be
Medicaid Final Rule. The application
either electronic or written comments made publicly available, submit your
may be submitted to an Exchange,
on the draft guidance by May 24, 2016. comments only as a written/paper
Medicaid or CHIP agency. The
ADDRESSES: You may submit comments submission. You should submit two
electronic application process will vary
as follows: copies total. One copy will include the
depending on each applicant’s
information you claim to be confidential
circumstances, their experience with Electronic Submissions with a heading or cover note that states
health insurance applications and Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
online capabilities. The goal is to solicit following way: CONFIDENTIAL INFORMATION.’’ The
sufficient information so that in most • Federal eRulemaking Portal: http:// Agency will review this copy, including
cases no further inquiry will be needed. www.regulations.gov. Follow the the claimed confidential information, in
Form Number: CMS–10440 (OMB instructions for submitting comments. its consideration of comments. The
control number: 0938–1191); Frequency: Comments submitted electronically, second copy, which will have the
Annually; Affected Public: Individuals including attachments, to http:// claimed confidential information
and Households; Number of www.regulations.gov will be posted to redacted/blacked out, will be available
Respondents: 7,200,000; Total Annual the docket unchanged. Because your for public viewing and posted on
Responses: 7,200,000; Total Annual comment will be made public, you are http://www.regulations.gov. Submit
Hours: 2,410,767. (For policy questions solely responsible for ensuring that your both copies to the Division of Dockets
regarding this collection contact Beth comment does not include any Management. If you do not wish your
Liu at 301–492–4135.) confidential information that you or a name and contact information to be
third party may not wish to be posted, made publicly available, you can
Dated: March 22, 2016.
such as medical information, your or provide this information on the cover
William N. Parham, III, anyone else’s Social Security number, or sheet and not in the body of your
Director, Paperwork Reduction Staff, Office confidential business information, such comments and you must identify this
of Strategic Operations and Regulatory as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Affairs. that if you include your name, contact information marked as ‘‘confidential’’
[FR Doc. 2016–06830 Filed 3–24–16; 8:45 am] information, or other information that will not be disclosed except in
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4120–01–P identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
VerDate Sep<11>2014 18:30 Mar 24, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1](https://thefederalregister.org/doc/81_FR_16242/page/3.svg)
Document Created: 2018-02-02 15:17:58
Document Modified: 2018-02-02 15:17:58
| 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 April 25, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 16184 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR