80 FR 69677 - Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 217 (November 10, 2015)

Page Range		69677-69679
FR Document		2015-28475

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Data Collection for the Residential Care Community and Adult Day Services Center Components of the National Study of Long-Term Care Providers. The purpose is to collect data for the residential care community and adult day services center components for the 2016 wave of the National Study of Long-Term Care Providers.

Federal Register, Volume 80 Issue 217 (Tuesday, November 10, 2015)

[Federal Register Volume 80, Number 217 (Tuesday, November 10, 2015)]
[Notices]
[Pages 69677-69679]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28475]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0943; Docket No. CDC-2015-0098]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on Data Collection 
for the Residential Care Community and Adult Day Services Center 
Components of the National Study of Long-Term Care Providers. The 
purpose is to collect data for the residential care community and adult 
day services center components for the 2016 wave of the National Study 
of Long-Term Care Providers.

DATES: Written comments must be received on or before January 11, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0098 by any of the following methods:

[[Page 69678]]

     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

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. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Residential Care Community and Adult Day Service Center Components 
of the National Study of Long-Term Care Providers (OMB Control No. 
0920-0943 Exp. Date: 07/31/2015)--Reinstatement with change--National 
Center for Health Statistics (NCHS), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 
242k), as amended, authorizes that the Secretary of Health and Human 
Services (DHHS), acting through NCHS, ``shall collect statistics on 
health resources . . . [and] utilization of health care, including 
extended care facilities, and other institutions.''
    NCHS seeks approval to collect data for the residential care 
community (RCC) and adult day services center (ADSC) survey components 
of the 3rd wave of the National Study of Long-Term Care Providers 
(NSLTCP). A two year clearance is requested.
    As background here are some details on the complete study design. 
The NSLTCP, a voluntary survey, is designed to (1) broaden NCHS' 
ongoing coverage of paid, regulated long-term care (LTC) providers; (2) 
merge with existing administrative data on LTC providers and service 
users (i.e., Centers for Medicare and Medicaid Services (CMS) data on 
nursing homes and residents, home health agencies and patients, and 
hospices and patients); (3) update data more frequently on LTC 
providers and service users for which nationally representative 
administrative data do not exist; and (4) enable comparisons across LTC 
sectors and timely monitoring of supply and use of these sectors over 
time.
    Data will be collected from two types of LTC providers in the 50 
states and the District of Columbia: 11,690 RCCs and 5,440 ADSCs in 
each wave. Data were collected in 2012 and 2014. The data to be 
collected beginning in 2016 include the basic characteristics, 
services, staffing, and practices of RCCs and ADSCs, and aggregate-
level distributions of the demographics, selected health conditions and 
health care utilization, physical functioning, and cognitive 
functioning of RCC residents and ADSC participants.
    Expected users of data from this collection effort include, but are 
not limited to CDC; other Department of Health and Human Services 
(DHHS) agencies, such as the Office of the Assistant Secretary for 
Planning and Evaluation and the Agency for Healthcare Research and 
Quality; associations, such as LeadingAge (formerly the American 
Association of Homes and Services for the Aging), National Center for 
Assisted Living, American Seniors Housing Association, Assisted Living 
Federation of America, and National Adult Day Services Association; 
universities; foundations; and other private sector organizations such 
as the Alzheimer's Association and the AARP Public Policy Institute.
    Expected burden from data collection is 30 minutes per respondent. 
We estimate that 5% of RCC and ADSC directors will be called for an 
additional 5 minutes of data retrieval when there are errors or 
omissions in their returned questionnaires. Two year clearance is 
requested to cover the collection of data. The burden for the 
collection is shown in Table 1 below. There is no cost to respondents 
other than their time to participate.

                                        Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per  response   Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
RCC Director/Designated Staff.  RCC                        5,846               1           30/60           2,923
                                 Questionnaire.

[[Page 69679]]

 
ADSC Director/Designated Staff  ADSC                       2,720               1           30/60           1,360
                                 Questionnaire.
RCC and ADSC Directors/         Data Retrieval..             429               1            5/60              36
 Designated Staff.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           4,319
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-28475 Filed 11-9-15; 8:45 am]
BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices 69677

suppliers likely to enter this market in four countries. Its business focuses on the proposed Order permits Mylan to
the near future. As there is no generic developing, manufacturing, and retain the right to sell acyclovir
version of Transderm Scop on the distributing generic, branded, and OTC ointment through a license from
market today, it is likely that the price pharmaceutical products. Mylan must Alvogen until thirty days after Mylan
for scopolamine transdermal patches accomplish the divestitures to Alvogen receives approval for the Perrigo ANDA,
would significantly decrease with the and relinquish its rights to these but for no longer than three years. This
onset of generic competition. Without a products no later than thirty days after provision is designed to permit Mylan
remedy, the proposed acquisition would the proposed acquisition is to remain an active market participant
eliminate the price reductions that consummated. pending the approval of Perrigo’s
would likely have accompanied Mylan’s The Commission’s goal in evaluating acyclovir ointment ANDA but also
independent entry into this market. possible purchasers of divested assets is ensures Mylan’s continued incentive to
to maintain the competitive develop and launch the Perrigo product.
II. Entry environment that existed prior to the The purpose of this analysis is to
Entry into each of these generic proposed acquisition. If the Commission facilitate public comment on the
pharmaceutical markets would not be determines that Alvogen is not an proposed Consent Agreement, and it is
timely, likely, or sufficient in acceptable acquirer, or that the manner not intended to constitute an official
magnitude, character, and scope to deter of the divestitures is not acceptable, the interpretation of the proposed Order or
or counteract the anticompetitive effects proposed Order requires Mylan to to modify its terms in any way.
of the proposed acquisition. The unwind the sale of rights to Alvogen
combination of drug development times By direction of the Commission.
and to divest the products to a
and regulatory requirements, including Commission-approved acquirer within Donald S. Clark,
approval by the United States Food and six months of the date the Order Secretary.
Drug Administration (‘‘FDA’’), is costly becomes final. The proposed Order [FR Doc. 2015–28522 Filed 11–9–15; 8:45 am]
and lengthy. further allows the Commission to BILLING CODE 6750–01–P

III. Effects appoint a trustee if Mylan fails to divest
the products as required.
The proposed acquisition likely The proposed Consent Agreement
would cause significant anticompetitive DEPARTMENT OF HEALTH AND
contains several provisions to help
harm to consumers by eliminating HUMAN SERVICES
ensure that the divestitures are
current or future competition between successful. The Order requires Mylan to Centers for Disease Control and
Mylan and Perrigo in these seven take all action to maintain the economic Prevention
concentrated markets. In each of these viability, marketability, and
markets, Mylan and Perrigo are two of competitiveness of the products to be [60Day–16–0943; Docket No. CDC–2015–
a limited number of current or likely divested until such time that they are 0098]
future suppliers in the United States. transferred to a Commission-approved
Market participants characterize each of acquirer. Mylan must provide Proposed Data Collections Submitted
the markets as a current or likely future transitional services to Alvogen to assist for Public Comment and
commodity market, in which the it in establishing independent Recommendations
number of generic suppliers has a direct manufacturing capabilities. These AGENCY: Centers for Disease Control and
impact on pricing. Customers and transitional services include technical Prevention (CDC), Department of Health
competitors have observed that the price assistance to manufacture the and Human Services (HHS).
of generic pharmaceutical products divestiture products in substantially the
decreases with new entry even after same manner and quality employed or ACTION: Notice with comment period.
several suppliers have entered the achieved by Mylan, and advice and SUMMARY: The Centers for Disease
market. Removal of an independent training from knowledgeable Mylan Control and Prevention (CDC), as part of
generic pharmaceutical supplier from employees. Mylan must also provide its continuing efforts to reduce public
the relevant markets in which Mylan Alvogen with a supply of the divested burden and maximize the utility of
and Perrigo currently compete likely products while Mylan transfers government information, invites the
would result in significantly higher manufacturing technology to Alvogen or general public and other Federal
prices post-acquisition. Similarly, the its designated manufacturer. The goal of agencies to take this opportunity to
elimination of a future independent the transitional services is to ensure that comment on proposed and/or
competitor would prevent the price Alvogen will be able to operate
continuing information collections, as
decreases that are likely to result from independent of Mylan in the
required by the Paperwork Reduction
the firm’s entry. Thus, absent a remedy, manufacture and sale of the divested
Act of 1995. This notice invites
the proposed acquisition will likely products. Nothing in the Consent
comment on Data Collection for the
cause U.S. consumers to pay Agreement, however, precludes Alvogen
Residential Care Community and Adult
significantly higher prices for these from sourcing active pharmaceutical
Day Services Center Components of the
generic drugs. ingredients or other divestiture product
National Study of Long-Term Care
inputs from Mylan on a negotiated
IV. The Consent Agreement Providers. The purpose is to collect data
basis.
The proposed Consent Agreement As Alvogen was unable to perform for the residential care community and
asabaliauskas on DSK5VPTVN1PROD with NOTICES

effectively remedies the proposed due diligence on the Perrigo products at adult day services center components
acquisition’s anticompetitive effects in issue, Mylan divested its own on- for the 2016 wave of the National Study
each relevant market. Under the market, generic acyclovir ointment of Long-Term Care Providers.
Consent Agreement, Mylan is required product rather than Perrigo’s product in DATES: Written comments must be
to divest to Alvogen its rights to the development. Because the competition received on or before January 11, 2016.
seven relevant products. Alvogen is an that is preserved by the proposed ADDRESSES: You may submit comments,
international pharmaceutical company, Consent Agreement will only occur identified by Docket No. CDC–2015–
with commercial operations in thirty- when the Perrigo product is launched, 0098 by any of the following methods:

VerDate Sep<11>2014 19:41 Nov 09, 2015 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\10NON1.SGM 10NON1

Document Created: 2018-03-01 11:25:04
Document Modified: 2018-03-01 11:25:04

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 with comment period.
Dates		Written comments must be received on or before January 11, 2016.
Contact		To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation		80 FR 69677

80 FR 69677 - Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 217 (November 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention