54388 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 

impact of Head Start Programs. The 

September 28–29, 2005 meeting 

provides an opportunity for the 

Advisory Committee to provide advice 

on the analysis plans for the study 

following the June 2005 release on the 

first impact findings. 

DATES: September 28 (9 a.m.–4 p.m.) 

and 29 (9 a.m.–12:30 p.m.), 2005. 

Place: Bethesda Park Clarion Hotel, 

8400 Wisconsin Avenue, Bethesda, MD 

20814; Phone: (301) 654–1000; Fax: 

(301) 654–0751. 

SUPPLEMENTARY INFORMATION: This 

meeting is open to the public and is 

barrier free. Meeting records will also be 

open to the public and will be kept at 

the Aerospace Building, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447. The Administration for Children 

and Families also intends to make 

material related to this meeting 

available on the Office of Planning, 

Research and Evaluation Web site 

(http://www.acf.hhs.gov/programs/opre/ 

index.html). An interpreter for the deaf 

and hearing impaired will be available 

upon advance request by calling Xtria at 

703–821–6182. 

FOR FURTHER INFORMATION CONTACT: 

Maria Woolverton at 202–205–4039 for 

substantive information. Contact ACF 

Office of Public Affairs at 202–401–9215 

for press inquiries. Contact Xtria at 703–

821–6182 for logistical information. 

Dated: September 7, 2005. 

Naomi Goldstein, 

Director, Office of Planning, Research and 

Evaluation, ACF. 

[FR Doc. 05–18257 Filed 9–13–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0353] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Pharmaceutical 

Development Study 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. 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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a proposed Pharmaceutical 

Development Study. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 14, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Karen L. Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘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 provide a 60-day notice in 

the Federal Register before submitting 

the collection to OMB for approval. To 

comply with this requirement, FDA is 

publishing notice of the proposed 

collection of information set forth in 

this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Pharmaceutical Development Study 

FDA’s Office of Pharmaceutical 

Science (OPS) of the Center for Drug 

Evaluation and Research is proposing 

collaboration under a Cooperative 

Research and Development Agreement 

(CRADA) with Conformia Software, Inc. 

of Redwood City, CA (hereafter referred 

to as ‘‘CRADA Partner’’), to collect 

information using focus group 

discussions with firms to determine 

what factors may influence 

pharmaceutical development. These 

factors include development 

information bottlenecks, pilot plant 

information management, 

manufacturing science, information 

retrieval, quality systems and preclinical development challenges. 

The FDA has introduced three new 

initiatives to help manufacturers 

develop higher quality drugs faster and 

cheaper. These initiatives include, but 

are not limited to, the following: 

• Challenge and Opportunity on the 

Critical Path to New Medical Products 

(commonly referred to as the ‘‘Critical 

Path Initiative’’) 

• Pharmaceutical cGMPs for the 21st 

Century—A Risk Based Approach 

• International Conference on 

Harmonization (ICH) Steering 

Committee Guidelines—Pharmaceutical 

Development, ICH Q8 (Defining the 

Design Space) 

The proposed study is designed to 

augment and support these initiatives 

by providing practical industry 

experiences and feedback to help FDA 

refine these initiatives. The scope of the 

proposed collaboration is aligned with 

FDA’s ‘‘Critical Path’’ of development-- 

specifically, the area between selection 

of drug candidates and commercial 

manufacturing. 

Gathering information through this 

collaboration represents an opportunity 

for FDA to gain insights into current 

industry practices and provide the 

opportunity to better understand the 

specific factors that contribute to drug 

development difficulties. There is a 

perceived reluctance by industry to 

share information with regulatory 

bodies (outside of the formal review 

processes). Therefore, obtaining 

necessary and timely information 

through this collaboration will help the 

Critical Path Initiative progress. 

The information collected will be 

used to create a clearer picture of 

current development bottlenecks, 

identify current state practices, 

highlight potential improvements in 

production, and provide feedback to 

FDA on the impact of current regulatory 

guidance. 

Use of information: The three groups 

who will be involved with the study 

may benefit by the collection of this 

information as follows: 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 54389 

• Industry—Participants will 

compare current drug development 

practices and processes identified in the 

study with current FDA guidance. 

Companies will be able to gain a better 

understanding of the steps needed to 

achieve the operational goals introduced 

through the Critical Path, ICH-Q8, and 

Pharmaceutical cGMPs for the 21st 

Century. 

• FDA—In its Critical Path initiative, 

FDA has called for better tools and 

techniques to be developed to help 

facilitate and improve productivity. The 

information gained will provide a better 

understanding of what steps will be 

needed to achieve this goal: To help 

companies reduce time spent in 

pharmaceutical development and speed 

the adoption of new technologies aimed 

at producing higher quality products at 

reduced costs. 

• CRADA Partner—In collaboration 

with FDA, the CRADA partner will use 

research findings to better understand 

informational requirements of 

companies in the area of pharmaceutical 

development, particularly as they relate 

to accomplishing the goals of the three 

FDA initiatives described previously. 

This includes tools that may be utilized 

within the company environment to 

reduce bottlenecks and enhance 

communication of key pharmaceutical 

information, as well as tools that may 

assist FDA in the review of 

pharmaceutical development 

submissions. 

Thus the study will assist all three 

party’s understanding of the 

requirements to address the current 

state in dealing with pharmaceutical 

development challenges. 

Confidentiality of Respondents: The 

CRADA Partner will provide an 

‘‘Informed Consent’’ form to all 

companies that participate in the study. 

This form highlights and assures all 

participants that company-specific 

responses (or responses unique to a 

specific company) will not, under any 

circumstances, be divulged to other 

participants or the FDA without the 

company’s prior consent. The CRADA 

Partner will also provide a Confidential 

Disclosure Agreement (CDA) to all 

participants assuring them 

confidentiality of disclosed information 

and adherence to the Privacy Act. 

Participation in the study: The 

CRADA Partner will post on its Web site 

an invitation for industry to participate 

in the study. It will also fax the 

invitation to 20 of the top 

pharmaceutical companies and 20 of the 

top biotech companies. The invitation 

will be sent to the offices of regulatory 

affairs, research and development, and 

information management. The FDA will 

also post the CRADA abstract on its Web 

site along with instructions on how to 

participate in the study. Within each 

company separate, small focus groups 

will be formed for the three offices. 

Company management in consultation 

with the CRADA Partner will determine 

the actual makeup of the focus groups, 

but the objective is to have a crossfunctional representation of experienced 

employees from each office. 

Method of study: The CRADA Partner 

will conduct a preliminary phase of the 

study with individual representatives of 

nine firms (through dialogue with the 

Vice President (VP) of Development), 

who volunteer for participation in the 

study. VP of Development and the 

CRADA Partner will determine the 

specific representation from each 

company jointly, but the objective will 

be to include representatives from the 

office of regulatory affairs, research and 

development, and information 

technology. The results of these 

preliminary interviews will be used to 

refine the full study agenda, which will 

be used to conduct focus group 

discussions from 25 companies. Both 

the preliminary phase and the final 

study agenda will include review and 

comment by FDA technical and 

regulatory experts and CRADA Partner 

personnel. 

The CRADA Partner will summarize 

interview findings for the full study and 

will remove references to specific firms, 

or information that could be used to 

identify specific firms, before sharing 

information with FDA. Follow-on 

questions will be identified by 

consultation between FDA and CRADA 

Partner personnel and these questions 

will be addressed in subsequent focus 

group interviews. Although companies 

are strongly encouraged to participate in 

these follow-on interviews, they may 

discontinue participation at any time. 

As an incentive for companies to 

participate in the study, the CRADA 

Partner will prepare a confidential 

report which contrasts practices in each 

company in comparison with aggregated 

information from other companies. At 

all times, the identity of a participating 

firm will be limited to the company 

itself and to the CRADA Partner. This 

blinded methodology is an industry 

standard methodology for other areas of 

current state best practices research. 

FDA personnel in collaboration will 

review final results with the CRADA 

Partner to determine appropriate next 

steps. These next steps may include 

training sessions with industry to 

increase industry awareness of 

pharmaceutical development practices 

and opportunities for improving these 

in conjunction with FDA’s 

manufacturing and related 

industrialization initiatives; industry 

workshops to discuss and explore 

findings of the study; a publication or 

publications summarizing the study 

results; additional studies to further 

expand FDA’s understanding of 

particular aspects of pharmaceutical 

development that may benefit from 

regulatory reform and steamlining; and 

adjustments to FDA’s regulatory strategy 

to help remove unnecessary or 

unintended burdens on industry. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses Hours per Response Total Hours 

25 1 25 20 500 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

54390 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 

Dated: September 7, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18163 Filed 9–13–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0349] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Food and Drug 

Administration Survey of Current 

Manufacturing Practices in the Food 

Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish a notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a proposed survey of current 

manufacturing practices in the food 

industry. The purpose of the proposed 

survey is to improve FDA’s 

understanding of current food industry 

manufacturing practices. The 

information will be used to assess what 

impact, if any, new manufacturing 

requirements would make on the food 

industry. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 14, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘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 provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

FDA Survey of Current Manufacturing 

Practices in the Food Industry 

The authority for FDA to collect the 

information derives from the FDA 

Commissioner’s authority, as specified 

in section 903(d)(2) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

393(d)(2)). 

FDA’s regulations in part 110 of Title 

21 of the Code of Federal Regulations 

(21 CFR part 110) describe the methods, 

equipment, facilities and controls for 

producing processed food, hereafter 

referred to as food CGMPs. As the 

minimum sanitary and processing 

requirements for producing safe and 

wholesome food, CGMPs are an 

important part of regulatory control of 

the nation’s food supply. FDA believes 

that it is necessary to revisit and 

modernize the food CGMPs. Since the 

food CGMPs were last revised in 1986, 

there have been significant changes in 

food production technology and 

important advances in the 

understanding of foodborne illnesses. 

Accordingly, the agency will rigorously 

assess the impacts of any modernization 

policies on food facilities. To assess the 

impacts of the modernization policy, 

information is needed to help 

understand baseline or current industry 

practice. At present, however, FDA 

lacks baseline information on the nature 

of current manufacturing practices that 

would serve as part of a regulatory 

impact analysis. 

FDA plans to conduct an Internet 

survey of all domestic FDA-registered 

facilities that primarily manufacture or 

process food and all foreign FDAregistered facilities that primarily 

manufacture or process food, which are 

located in those countries that are the 

largest food exporters to the United 

States: Japan, Canada, China, France, 

Italy and Mexico. The Internet survey 

will be supplemented by extended case 

study interviews with selected 

respondents from the survey. The 

survey and extended case studies will 

solicit detailed information about six 

key topics relevant to the food CGMPs 

modernization effort: employee training, 

sanitation and personal hygiene, 

allergen controls, process controls, postproduction processing, and 

recordkeeping. Additionally, FDA will 

collect information on establishment 

characteristics, such as facility size and 

industry, which are expected to 

correlate with the presence or absence 

of various manufacturing practices, such 

as electronic recordkeeping, ongoing 

employee training in food safety, and 

product-to-label conformance 

procedures. The case study interviews 

will provide qualitative, in-depth 

information about various factors that 

influence decisions to implement these 

types of manufacturing practices, as 

well as about the circumstances that 

underlie the cost and effectiveness of 

such programs. The survey will be sent 

to every FDA-registered facility in the 

United States, Japan, Canada, China, 

France, Italy and Mexico that primarily 

manufactures or processes food 

products and that included an e-mail 

address with their registration. 

Participation will be voluntary and the 

respondent identifiers that would 

permit an association of specific 

responses to specific respondents will 

not be accessible to FDA. 

The proposed Internet survey will 

collect the information from 

respondents electronically. With a 

custom-designed online survey system, 

responses will be entered directly into 

a computer database, eliminating the 

need for additional coding and data 

entry operations. Also, the system will 

ensure that conditional questions are 

asked in proper order, freeing the