Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Notices 20405 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–372(S), CMS–R– 

306, CMS–10180 and CMS–R–199] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this 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 function; 

(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. 

1. Type of Information Collection 

Request: Reinstatement without change 

of a currently approved collection; Title 

of Information Collection: Annual 

Report on Home and Community Based 

Services Waivers and Supporting 

Regulations in 42 CFR 440.180 and 

441.300–310; Use: CMS is asking the 

States to report financial and statistical 

information concerning the numbers of 

Medicaid beneficiaries receiving waiver 

services, the type of services provided 

and the costs of those services. The 

information is usually taken from State 

Medicaid agency data processing 

systems. This data is summarized and 

may be submitted to CMS through the 

372 web-based form. The report is used 

by CMS to compare actual data in the 

approved waiver estimates and, in 

conjunction with the waiver compliance 

review reports, the information 

provided is compared to that in the 

Medicaid Statistical Information System 

(CMS–R–284, OCN 0938–0345) report 

and Federal financial participation 

claimed on a State’s Quarterly 

Expenditure Report (CMS–64, OCN 

0938–0067), to determine whether to 

continue the State’s home and 

community-based services waiver. 

States’ estimates of cost and utilization 

for renewal purposes are based upon the 

data compiled in the CMS Form 372(S) 

reports. There have been no changes to 

the PRA package that is associated with 

the 60-day notice that published on 

January 24, 2012 (77 FR 3477); Form 

Number: CMS–372(S) (OCN 0938– 

0272); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

49; Total Annual Responses: 305; Total 

Annual Hours: 13,115. (For policy 

questions regarding this collection 

contact Ralph Lollar at 410–786–0777. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Condition of Participation—Use of 

Restraint and Seclusion in Psychiatric 

Residential Treatment Facilities 

Providing Psychiatric Services to 

Individuals Under Age 21 and 

Supporting Regulations at 42 CFR 

483.350–483.376; Use: Psychiatric 

Residential Treatment Facilities are 

required to report deaths, serious 

injuries and attempted suicides to the 

State Medicaid Agency and the 

Protection and Advocacy Organization. 

They are also required to provide 

residents the restraint and seclusion 

policy in writing, and to document in 

the residents’ records all activities 

involving the use of restraint and 

seclusion. There have been no changes 

to the PRA package that is associated 

with the 60-day notice that published 

on January 13, 2012 (77 FR 2067); Form 

Number: CMS–R–306 (OCN 0938–0833); 

Frequency: Once and Occasionally; 

Affected Public: Private Sector (Business 

or other for-profits); Number of 

Respondents: 376; Total Annual 

Responses: 329,500; Total Annual 

Hours: 501,750. (For policy questions 

regarding this collection contact Jean 

Close at 410–786–2804 or Melissa 

Musotto at 410–786–6962. For all other 

issues call 410–786–1326.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Children’s 

Health Insurance Program (CHIP) Report 

on Payables and Receivables; Use: 

Collection of CHIP data and the 

calculation of the CHIP Incurred But 

Not Reported (IBNR) estimate are 

pertinent to CMS’ financial audit. The 

CFO auditors have reported the lack of 

an estimate for CHIP IBNR payables and 

receivables as a reportable condition in 

the FY 2005 audit of CMS’s financial 

statements. It is essential that CMS 

collect the necessary data from State 

agencies in FY 2006, so that CMS 

continues to receive an unqualified 

audit opinion on its financial 

statements. Program expenditures for 

the CHIP have increased since its 

inception; as such, CHIP receivables and 

payables may materially impact the 

financial statements. The CHIP Report 

on Payables and Receivables will 

provide the information needed to 

calculate the CHIP IBNR; Form Number: 

CMS–10180 (OMB#: 0938–0988); 

Frequency: Reporting—Annually; 

Affected Public: State, Local or Tribal 

governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 392. (For policy 

questions regarding this collection 

contact Michele Myers at 410–786– 

7911. For all other issues call 410–786– 

1326.) 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid Report 

on Payables and Receivables; Use: The 

Chief Financial Officers (CFO) Act of 

1990, as amended by the Government 

Management Reform Act (GMRA) of 

1994, requires government agencies to 

produce auditable financial statements. 

Because the Centers for Medicare & 

Medicaid Services (CMS) fulfills its 

mission through its contractors and the 

States, these entities are the primary 

source of information for the financial 

statements. There are three basic 

categories of data: Expenses, payables, 

and receivables. The CMS–64 is used to 

collect data on Medicaid expenses. The 

CMS–R–199 collects Medicaid payable 

and receivable accounting data from the 

States. Form Number: CMS–R–199 

(OMB#: 0938–0697); Frequency: 

Reporting—Annually; Affected Public: 

State, Local or Tribal governments; 

Number of Respondents: 56; Total 

Annual Responses: 56; Total Annual 

Hours: 336. (For policy questions 

regarding this collection contact 

Michele Myers at 410–786–7911. For all 

other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on May 4, 2012. 


emcdonald on DSK29S0YB1PROD with NOTICES
20406 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Notices 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 

395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: March 28, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–8011 Filed 4–3–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0288] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Draft Guidance for Industry on 

Statistical Evaluation of Stability Data, 

VICH GL51; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry (#219) entitled ‘‘Draft Guidance 

for Industry on Statistical Evaluation of 

Stability Data, VICH GL51.’’ 

This draft guidance has been 

developed for veterinary use by the 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH). 

This draft VICH guidance document is 

intended to provide recommendations 

on how to use stability data generated 

in accordance with the principles 

detailed in the VICH guidance entitled 

‘‘Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products, GL3(R)’’ to propose a retest 

period or shelf life in a registration 

application. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 4, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Mai 

Huynh, Center for Veterinary Medicine, 

(HFV–142), Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–276–8273, 

Mai.huynh@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (#219) 

entitled, ‘‘Draft Guidance for Industry 

on Statistical Evaluation of Stability 

Data, VICH GL51.’’ In recent years, 

many important initiatives have been 

undertaken by regulatory authorities 

and industry associations to promote 

the international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 

Requirements for Approval of 

Pharmaceuticals for Human Use for 

several years to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission, the 

European Medicines Evaluation Agency, 

the European Federation of Animal 

Health, the Committee on Veterinary 

Medicinal Products, FDA, the U.S. 

Department of Agriculture, the Animal 

Health Institute, the Japanese Veterinary 

Pharmaceutical Association, the 

Japanese Association of Veterinary 

Biologics, and the Japanese Ministry of 

Agriculture, Forestry, and Fisheries. 

Four observers are eligible to 

participate in the VICH Steering 

Committee: One representative from the 

government of Australia/New Zealand, 

one representative from the industry in 

Australia/New Zealand, one 

representative from the government of 

Canada, and one representative from the 

industry of Canada. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation for Animal Health (IFAH). 

An IFAH representative also 

participates in the VICH Steering 

Committee meetings. 

II. Draft Guidance on Statistical 

Evaluation of Stability Data 

The VICH Steering Committee held a 

meeting on November 14, 2011, and 

agreed that the draft guidance document 

entitled ‘‘Draft Guidance for Industry on 

Statistical Evaluation of Stability Data, 

VICH GL51’’ should be made available 

for public comment. This draft VICH 

guidance document is intended to 

provide recommendations on how to 

use stability data generated in 

accordance with the principles detailed 

in the VICH guidance entitled, 

‘‘Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products, GL3(R)’’ to propose a retest 

period or shelf life in a registration 

application. This draft guidance 

describes when and how extrapolation 

can be considered when proposing a 

retest period for a drug substance or a 

shelf life for a veterinary medicinal 

product that extends beyond the period 

covered by available data from the 

stability study under the long-term 

storage condition. 

This draft guidance addresses the 

evaluation of stability data that should 

be submitted in registration applications 

for new molecular entities and 

associated veterinary medicinal 

products. The draft guidance provides 

recommendations on establishing retest 

periods and shelf lives for drug 

substances and veterinary medicinal 

products intended for storage at or 

below ‘‘room temperature.’’ It covers 

stability studies using single- or multifactor designs and full or reduced 

designs. 

FDA and the VICH Expert Working 

Group will consider comments about 

the draft guidance document. 


emcdonald on DSK29S0YB1PROD with NOTICES