Federal Register / Vol. 74, No. 109 / Tuesday, June 9, 2009 / Notices 27325 

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; and (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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

National Survey of Residential Care 

Facilities (NSRCF), (OMB No. 0920– 

0780)—Revision— 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.’’ 

In 2008, NCHS sought approval for a 

pretest and full survey of The National 

Survey of Residential Care Facilities 

(NSRCF). OMB approved only the 

pretest which has been completed. 

NCHS now seeks approval to collect the 

full survey. The survey is designed to 

complement data collected by other 

federal surveys and to fill a significant 

data gap about a major portion of the 

long-term care population. Data from 

NSRCF will provide information on 

residential care facilities that 

policymakers, providers, and 

researchers can use to address a wide 

array of policy and research questions. 

The survey will utilize a computerassisted personal interviewing (CAPI) 

system to collect information about 

facility and resident characteristics. 

This computerized system speeds the 

flow of data and makes it possible to 

release information on a timelier basis 

and easier for respondents to participate 

in the survey. The CAPI system may 

also enhance data quality. Clearance for 

two years is requested. 

A stratified random sample of 

residential care facilities across four 

strata (small, medium, large and very 

large) will be selected to participate in 

NSRCF. Within each facility a random 

sample of residents will be selected. To 

be eligible a facility must be licensed, 

registered, listed, certified, or otherwise 

regulated by the State; provide room 

and board with at least two meals a day; 

provide around-the-clock on-site 

supervision; help with activities of daily 

living (e.g., bathing, eating, or dressing) 

or medication supervision; serve 

primarily an adult population; and have 

at least four beds. 

The facility questionnaire will collect 

data about facility characteristics (e.g., 

size, age, types of rooms), services 

offered, characteristics of the resident 

population, facility policies and 

services, charges for services, and 

background of the director. The resident 

questionnaire collects information on 

resident demographics, current living 

arrangements within the facility, 

involvement in activities, use of 

services, charges for care, health status, 

and cognitive and physical functioning. 

For the national survey, approximately 

2,250 facilities will be surveyed for an 

annual average of 1,125 facilities. 

Information on an average of 4 residents 

will be collected from an annual average 

of 1,125 facility staff. Residents 

themselves will not be interviewed. 

Users of NSRCF data 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; and 

associations, such as the American 

Association of Homes and Services for 

the Aging, National Center for Assisted 

Living, American Seniors Housing 

Association, Assisted Living Federation 

of America; universities; foundations; 

and other private sector organizations. 

There is no cost to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Name of form Number of 

respondents 

Number of 

responses/ 

respondent 

Average 

burden/ 

response 

(in hours) 

Response 

burden 

in hours 

Facility Director ..................................... Facility Screener .................................. 1125 1 10/60 188 

Facility Director ..................................... Resident Selection ............................... 1125 1 10/60 188 

Facility Director ..................................... Pre-Interview Worksheet ...................... 1125 1 15/60 281 

Facility Director ..................................... Facility Questionnaire ........................... 1125 1 1.25 1,406 

Facility Director or Staff Member .......... Resident Questionnaire ........................ 1125 4 20/60 1,500 

Total ............................................... ............................................................... ...................... ...................... ...................... 3,563 

Dated: June 3, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Office of 

the Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–13409 Filed 6–8–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0148] (formerly 

Docket No. 2007D–0493) 

International Conference on 

Harmonisation; Guidance on Q8(R1) 

Pharmaceutical Development; Addition 

of Annex; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Q8(R1) Pharmaceutical Development.’’ 

The guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The ICH Q8(R1) guidance includes the 

previously published parent guidance 

entitled ‘‘Q8 Pharmaceutical 

Development’’ (Q8 parent guidance) (71 

FR 29344; May 22, 2006) and a newly 

added annex. The annex provides 

27326 Federal Register / Vol. 74, No. 109 / Tuesday, June 9, 2009 / Notices 

further clarification of key concepts 

outlined in the Q8 parent guidance and 

describes the principles of quality by 

design (QbD). The annex is intended to 

show how concepts and tools (e.g., 

design space) outlined in the Q8 parent 

guidance could be put into practice by 

the applicant for all dosage forms. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send two self-addressed 

adhesive labels to assist the office in 

processing your requests. Submit 

written comments on the guidance to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Moheb Nasr, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 2630, 

Silver Spring, MD 20993–0002, 

301–796–1900; or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–25), Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200, Rockville, MD 

20852–1448, 301–827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of January 10, 

2008 (73 FR 1890), FDA published a 

notice announcing the availability of a 

draft guidance entitled ‘‘Q8(R1) 

Pharmaceutical Development Revision 

1.’’ The notice gave interested persons 

an opportunity to submit comments by 

April 9, 2008. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the guidance was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in 

November 2008. Revisions were made 

in response to comments received by 

the three ICH regions to better express 

the original intent of the draft. 

The annex added to the Q8 parent 

guidance provides further clarification 

of key concepts outlined in the Q8 

parent guidance and describes the 

principles of QbD. The annex is not 

intended to establish new standards or 

increase regulatory expectations. It is 

intended to show how concepts and 

tools (e.g., design space) outlined in the 

Q8 parent guidance could be put into 

practice by the applicant for all dosage 

forms. Following the addition of the 

annex to the Q8 parent guidance, ICH 

recoded the parent guidance Q8(R1). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written comments on the 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http://www.fda.

gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm. 

Dated: May 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13374 Filed 6–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Psychopharmacologic Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration