80 FR 43091 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 139 (July 21, 2015)

Page Range		43091-43093
FR Document		2015-17824

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 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 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.

Federal Register, Volume 80 Issue 139 (Tuesday, July 21, 2015)

[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43091-43093]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10387, CMS-10110 and CMS-10393]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 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 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 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.

[[Page 43092]]


DATES: Comments must be received by September 21, 2015.

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 
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: 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' 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 information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10387 Skilled Nursing Facility (SNF) Prospective Payment System and 
Consolidated

Billing

CMS-10110 Manufacturer Submission of Average Sales Price (ASP) Data for 
Medicare Part B

Drugs and Biologicals

CMS-10393 Medicare Beneficiary and Family-Centered Satisfaction 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. 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

    1. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Skilled Nursing Facility (SNF) Prospective Payment System and 
Consolidated Billing; Use: We are requesting approval of a 
reinstatement of a Change of Therapy OMRA for Skilled Nursing 
Facilities (SNFs). As described in CMS-1351-F, we finalized the 
assessment effective October 1, 2011. SNFs are required to submit this 
assessment. The COT OMRA is comprised of a subset of resident 
assessment information developed for use by SNFs to satisfy a Medicare 
payment requirement. The burden associated with this is the SNF staff 
time required to complete the COT OMRA, SNF staff time to encode the 
data, and SNF staff time spent in transmitting the data. SNFs are 
required to complete a COT OMRA when a SNF resident was receiving a 
sufficient level of rehabilitation therapy to qualify for an Ultra 
High, Very High, High, Medium, or Low Rehabilitation category and when 
the intensity of therapy (as indicated by the total reimbursable 
therapy minutes (RTM) delivered, and other therapy qualifiers such as 
number of therapy days and disciplines providing therapy) changes to 
such a degree that it would no longer reflect the RUG-IV classification 
and payment assigned for a given SNF resident based on the most recent 
assessment used for Medicare payment. The COT OMRA is a type of 
required PPS assessment which uses the same item set as the End of 
Therapy (EOT) OMRA. Form Number: CMS-10387 (OMB Control Number: 0938-
1140); Frequency: Yearly; Affected Public: Private sector (Business or 
other For-profits and Not-for-profit institutions); Number of 
Respondents: 15,421; Total Annual Responses: 678,524; Total Annual 
Hours: 701,119. (For policy questions regarding this collection contact 
Penny Gershman at 410-786-6643).
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare 
Part B Drugs and Biologicals; Use: In accordance with section 1847A of 
the Social Security Act (the Act), Medicare Part B covered drugs and 
biologicals not paid on a cost or prospective payment basis are paid 
based on the average sales price (ASP) of the drug or biological, 
beginning in Calendar Year (CY) 2005. The ASP data reporting 
requirements are specified in section 1927 of the Act. The reported ASP 
data are used to establish the Medicare payment amounts. The reporting 
template was revised in CY 2011 in order to facilitate accurate 
collection of ASP data. An accompanying user guide with instructions on 
the template's use was also created and included an explanation of the 
data elements in the template. Form Number: CMS-10110 (OMB Control 
Number: 0938-0921); Frequency: Quarterly; Affected Public: Private 
sector (Business or other For-profits); Number of Respondents: 180; 
Total Annual Responses: 720; Total Annual Hours: 34,560. (For policy 
questions regarding this collection contact Amy Gruber at 410-786-
1542).
    3. Type of Information Collection Request: Extension of a 
previously approved collection; Title of Information Collection: 
Medicare Beneficiary and Family-Centered Satisfaction Survey; Use: The 
data collection methodology used to determine Beneficiary Satisfaction 
flows from the proposed sampling approach. Based on recent literature 
on survey methodology and response rates by mode, we recommend using a 
data collection that is done primarily by mail. A mail-based 
methodology will achieve the goals of being efficient, effective, and 
minimally burdensome for beneficiary respondents. We anticipate that a 
mail-based methodology could yield a response rate of approximately 60 
percent. In order to achieve this response rate, we would recommend a 3 
staged approach to data collection:
    (1) Mailout of a covering letter, the paper survey questionnaire, 
and a postage-paid return envelope.
    (2) Mailout of a post card that thanks respondents and reminds the 
non-respondents to please return their survey.
    (3) Mailout of a follow-up covering letter, the paper survey 
questionnaire, and a postage-paid return envelope.

[[Page 43093]]

    Through the pilot test, we will determine the response rate that 
can be achieved using this approach. If it is deemed necessary, a 
prenotification letter, additional mailout reminders and a telephone 
non-response step can be added to the protocol to achieve desired 
response rate. Form Number: CMS-10393 (OMB Control number: 0938-1177); 
Frequency: Once; Affected Public: Individuals or households; Number of 
Respondents: 16,010; Number of Responses: 16,010; Total Annual Hours: 
4,002. (For policy questions regarding this collection, contact Coles 
Mercier at 410-786-2112.)

    Dated: July 16, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-17824 Filed 7-20-15; 8:45 am]
BILLING CODE 4120-01-P

Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43091

Background and Brief Description sources. Contaminated water and food hyperlink on the NORS main user page
can cause illness when people or to report individual human and animal
Due to defunding and as part of a animals have exposures to them. HABs case information related to HAB
revision in 2014 of the information are an emerging public health concern exposures. State agencies will
collection entitled National Disease with several outbreaks related to HAB voluntarily report single human and
Surveillance Program II: Disease exposures through contact, inhalation, animal illnesses related to HAB
Summaries (OMB Control Number and ingestion of contaminated fish, exposures, as well as environmental
0920–0004), CDC discontinued its data shellfish, and water. In humans and data about HABs.
collection of harmful algal bloom- animals, illnesses related to HAB
related illnesses through its Harmful HABISS data will include the date of
exposures have ranged from the HAB, the type of exposure that the
Algal Bloom-related Illness Surveillance dermatologic, respiratory,
System (HABISS). However, in part to person or animal had, the length of the
gastrointestinal, neurological illness, exposure, signs and symptoms, and
the Great Lakes Restorative Initiative, and even death. HABs might be
the National Center for Emerging and laboratory testing. No Personally
identified through the reporting of Identifiable Information (PII) will be
Zoonotic Infectious Diseases (NCEZID) single cases of human or animal illness
now considers harmful algal bloom- reported or collected. CDC will use the
as indicators. data to better characterize human and
related illness surveillance as a priority HABISS data will be reported by
and will seek a three-year OMB animal illnesses related to HAB
states and territories in a web-based exposures and to inform future
approval for HABISS. electronic reporting system. The prevention efforts, health departments,
The goal of harmful algal bloom- National Outbreak Reporting System federal partners and other stakeholders.
related illness surveillance is to collect (NORS) (OMB Control Number 0920–
data on harmful algal blooms (HABs), 0004) is an existing password-protected There are no costs to respondents
human illnesses, and animal illnesses web-based surveillance platform for other than their time.
related to HAB exposures and use the national reporting of foodborne, CDC will analyze and present the
data to better define and prevent HAB- waterborne, and other enteric outbreaks. collected data through summaries and
related illnesses. HABs are the fast HAB-related outbreaks can already be reports.
growth of aquatic organisms including reported by state and territorial health It is estimated that epidemiologists
algae, cyanobacteria, phytoplankton, departments in NORS; however, there is will report illnesses and HAB events
and similar organisms. HABs can currently no national surveillance for three times during the year with a
produce potent natural toxins that can single cases of human or animal burden of 20 minutes. An estimated
contaminate surface water used for illnesses. State and territorial staff with total burden for HABISS data reporting
recreation, drinking water, or food access to NORS will be able to use a is 57 hours per year.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)

State Epidemiologists ....................... Harmful Algal Bloom Illness Surveil- 57 3 20/60 57
lance System (HABISS) data ele-
ments (electronic, year-round).

Total ........................................... ........................................................... ........................ ........................ ........................ 57

Leroy A. Richardson, DEPARTMENT OF HEALTH AND PRA), federal agencies are required to
Chief, Information Collection Review Office, HUMAN SERVICES publish notice in the Federal Register
Office of Scientific Integrity, Office of the concerning each proposed collection of
Associate Director for Science, Office of the Centers for Medicare & Medicaid information (including each proposed
Director, Centers for Disease Control and Services extension or reinstatement of an existing
Prevention. collection of information) and to allow
[FR Doc. 2015–17792 Filed 7–20–15; 8:45 am] [Document Identifiers: CMS–10387, CMS– 60 days for public comment on the
10110 and CMS–10393]
BILLING CODE 4163–18–P proposed action. Interested persons are
Agency Information Collection invited to send comments regarding our
Activities: Proposed Collection; burden estimates or any other aspect of
Comment Request this collection of information, including
any of the following subjects: (1) The
AGENCY: Centers for Medicare & necessity and utility of the proposed
Medicaid Services, Department of information collection for the proper
Health and Human Services. performance of the agency’s functions;
asabaliauskas on DSK5VPTVN1PROD with NOTICES

ACTION: Notice. (2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
SUMMARY: The Centers for Medicare & utility, and clarity of the information to
Medicaid Services (CMS) is announcing be collected; and (4) the use of
an opportunity for the public to automated collection techniques or
comment on CMS’ intention to collect other forms of information technology to
information from the public. Under the minimize the information collection
Paperwork Reduction Act of 1995 (the burden.

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Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43093

Through the pilot test, we will Description: This is a financial report annually report on the methodology
determine the response rate that can be submitted following the end of each used to calculate adoption savings due
achieved using this approach. If it is fiscal quarter by each State or Tribe with to the application of differing title IV–
deemed necessary, a prenotification an approved title IV–E plan E Adoption Assistance eligibility
letter, additional mailout reminders and administering any of three title IV–E criteria for children designated as an
a telephone non-response step can be entitlement grant programs—Foster ‘‘applicable child’’ along with an
added to the protocol to achieve desired Care, Adoption Assistance or accounting of the amount of and the
response rate. Form Number: CMS– Guardianship Assistance. expenditure of any such savings.
10393 (OMB Control number: 0938– The purpose of this form is to enable To accommodate this change in the
1177); Frequency: Once; Affected each State or Tribe to meet its statutory law, we have added additional data
Public: Individuals or households; and regulatory requirement to report entry lines in part 4 of Form CB–496,
Number of Respondents: 16,010; program expenditures made in the ‘‘Annual Adoption Savings Calculation
Number of Responses: 16,010; Total preceding fiscal quarter and to estimate and Accounting Report’’ which will be
Annual Hours: 4,002. (For policy program expenditures to be made in the submitted annually by grantees.
questions regarding this collection, upcoming fiscal quarter. This form also
In addition, the same law adds
contact Coles Mercier at 410–786–2112.) allows States and Tribes to report the
additional requirements that title IV–E
actual and estimated average monthly
Dated: July 16, 2015. grantees develop and implement
number of children assisted in each of
William N. Parham, III, policies and procedures to identify,
the three IV–E entitlement grant
Director, Paperwork Reduction Staff, Office document, and determine appropriate
programs in the preceding and
of Strategic Operations and Regulatory services for any child or youth in the
upcoming fiscal quarters, respectively.
Affairs. The Administration for Children and placement, care or supervision of the
[FR Doc. 2015–17824 Filed 7–20–15; 8:45 am] Families provides Federal funding at the title IV–E agency who is at-risk of
BILLING CODE 4120–01–P rate of 50 percent for nearly all becoming a sex trafficking victim or
allowable and legitimate administrative who is determined as a sex trafficking
costs of these programs and at other victim.
DEPARTMENT OF HEALTH AND funding rates for other specific To accommodate this change in the
HUMAN SERVICES categories of costs as detailed in Federal law we have added additional reporting
statute and regulations. The information lines and prior quarter reporting odes
Administration for Children and collected in this report is used by this for expenditure reporting and child
Families agency to calculate quarterly Federal counts and in parts 1 and 2 of Form CB–
grant awards and to enable oversight of 496.
Submission for OMB Review; the financial management of the Respondents: States (including Puerto
Comment Request programs. Legislation enacted in 2014 Rico and the District of Columbia) and
through Public Law 113–183, the Tribes* with approved title IV–E plans.
Title: Form CB–496, ‘‘Title IV–E ‘‘Preventing Sex Trafficking and (*An estimated 15 Tribes have or will
Programs Quarterly Financial Report’’ Strengthening Families Act’’ added a have approved title IV–E plans within
OMB No.: 0970–0205 requirement that title IV–E grantees the next 3-year period.)

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Form CB–496: Title IV–E Programs Quarterly Financial Report .................... 67 4 21 5,628

Estimated Total Annual Burden publication. Written comments and DEPARTMENT OF HEALTH AND
Hours: 5,628. recommendations for the proposed HUMAN SERVICES
Additional Information: information collection should be sent
Copies of the proposed collection may directly to the following: Office of Food and Drug Administration
be obtained by writing to the Management and Budget, Paperwork [Docket No. FDA–2000–D–0067]
Administration for Children and Reduction Project, Email:
Families, Office of Planning, Research OIRA_SUBMISSION@OMB.EOP.GOV, Medical Device Patient Labeling;
and Evaluation, 370 L’Enfant Attn: Desk Officer for the Request for Comments; Public
Promenade SW., Washington, DC 20447, Administration for Children and Workshop
Attn: ACF Reports Clearance Officer. All Families. AGENCY: Food and Drug Administration,
requests should be identified by the title HHS.
of the information collection. Email Robert Sargis,
address: infocollection@acf.hhs.gov. Reports Clearance Officer. ACTION: Notice of public workshop;
asabaliauskas on DSK5VPTVN1PROD with NOTICES

request for comments.
OMB Comment: [FR Doc. 2015–17793 Filed 7–20–15; 8:45 am]
OMB is required to make a decision BILLING CODE 4184–01–P SUMMARY: The Food and Drug
concerning the collection of information Administration is announcing the
between 30 and 60 days after following public workshop entitled
publication of this document in the ‘‘Medical Device Patient Labeling’’. The
Federal Register. Therefore, a comment purpose of the public workshop is to
is best assured of having its full effect discuss issues associated with the
if OMB receives it within 30 days of development and use of medical device

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Document Created: 2018-02-23 09:23:15
Document Modified: 2018-02-23 09:23:15

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 September 21, 2015.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		80 FR 43091

80 FR 43091 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 139 (July 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services