65494 Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 

a recall plan, as provided in 21 CFR 

7.59, have been approved under OMB 

control number 0910–0249. Therefore, 

FDA is not calculating a new paperwork 

burden for recall plans. 

Preventative Control Program 

When properly designed and 

maintained by the establishment’s 

personnel, a preventive control program 

is a valuable program for managing the 

safety of food products. A common 

preventive control program used by the 

fresh-cut industry is a HACCP system. A 

HACCP system allows managers to 

assess the inherent risks and identify 

hazards attributable to a product or a 

process, and then determine the 

necessary steps to control the hazards. 

Monitoring and verification steps, 

which include recordkeeping, are 

included in the HACCP system to 

ensure that potential risks are 

controlled. We use HACCP as an 

example of a preventive control program 

that a firm may choose based on the 

recommendations in the guidance to 

estimate the burden of developing, 

implementing, and reviewing a 

preventive control program. 

FDA estimated the paperwork burden 

of developing and implementing a 

HACCP plan based on a plan with two 

CCPs. The number of CCPs may vary 

depending on how the processor 

chooses to identify the CCPs for a 

particular operation. Developing a 

HACCP plan is a one-time activity that 

is estimated to take 100 hours based on 

a trained HACCP team working on the 

plan full time. The HACCP team 

identifies the CCPs and measures 

needed to control them, and then 

identifies the approach needed to verify 

the effectiveness of the controls. During 

this plan development period, the firm 

chooses the records to be kept and 

information and observations to be 

recorded. This is a one-time process 

during the first year. 

In 2007, we previously estimated that, 

of the estimated 250 fresh-cut 

processors, approximately 50 percent of 

the firms already have HACCP plans in 

place. We therefore assumed that the 

remaining fresh-cut processors (125 

existing firms plus the 10 new firms), 

would voluntarily develop a HACCP 

plan, and estimated that 135 processors 

would spend 13,500 hours (135 × 100) 

to develop their individual HACCP 

plans. Accordingly, we only need to 

estimate the burden of this one-time 

activity on the 10 new businesses 

expected to enter the industry annually 

in the next 3 years. We estimate that the 

10 new firms will spend 100 hours each 

to develop their individual HACCP 

plans, for a total of 1,000 hours (10 × 

100). This burden estimate is shown in 

row 4 of table 1 of this document. 

After the HACCP plan is developed, 

the frequency for recordkeeping for 

implementing or maintaining daily 

records is estimated to be 510 records 

per year. (This is based on a firm 

choosing to maintain daily records for 2 

CCPs for one 8-hour shift per day for 

each of the estimated 255 operational 

days per year.) The total time to record 

observations for the CCPs was estimated 

to take 4 minutes or 0.067 hours per 

record. Therefore, the total annual 

records kept by 145 firms (the 135 firms 

plus the 10 new businesses expected to 

enter the industry) is 73,950 (510 × 145), 

and the total hours required are 4,955 

(73,950 records × 0.067 hours per record 

= 4,954.65, rounded to 4,955). This 

annual burden is shown in row 5 of 

table 1 of this document. 

After the HACCP plan has been 

developed and implemented, we 

recommend that the plan is reviewed 

regularly to ensure that it is working 

properly. Fresh-cut processors are 

estimated to review their HACCP plans 

four times per year (once per quarter). 

Assuming that it takes each of the 145 

firms 4 hours per review each quarter, 

the total burden of this activity, for 

firms that choose to review their plans 

annually, is 2,320 (145 × 4 × 4) hours 

per year. This annual burden is shown 

in row 6 of table 1 of this document. 

Dated: October 18, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26829 Filed 10–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Award of Three Single-Source 

Expansion Supplements to The 

University of Colorado Health Sciences 

Center in Aurora, CO, The University of 

Massachusetts (Institute for 

Community Inclusion) in Boston, MA, 

and The University of Minnesota (The 

Research and Training Center) in 

Minneapolis, MN 

AGENCY: Administration on 

Developmental Disabilities, ACF, HHS. 

ACTION: Notice. 

CFDA Number: 93.631. 

Statutory Authority: This award will 

be made pursuant to Section 161 of the 

Developmental Disabilities Assistance 

and Bill of Rights Act of 2000 (42 U.S.C. 

15081–15083). 

Amount of Award: $200,000 per 

award. 

Project Period: 9/30/2010–9/29/2012. 

SUMMARY: This notice announces that 

the Administration for Children and 

Families (ACF), Administration on 

Developmental Disabilities (ADD) has 

awarded three single-source expansion 

supplements for data collection, 

analyses, and reporting. 

The following projects will be funded: 

The University of Colorado Health 

Sciences Center, Aurora, CO. This 

cooperative agreement will allow for 

data collection, analysis and reporting 

on spending and services for 

individuals with intellectual and 

developmental disabilities, including 

disaggregation of data related to specific 

demographic groups. The project will 

analyze and report on trends in 

utilization of and spending for 

institutional services and home and 

community-based services. Project staff 

will also participate in collaborative 

efforts with ADD and other data 

collection projects to review and report 

on unmet needs in data collection, 

analyses, and reporting activities that 

would promote the self-determination, 

independence, productivity, and 

integration and inclusion of people with 

intellectual and developmental 

disabilities in all facets of community 

life. 

The University of Massachusetts 

(Institute for Community Inclusion), 

Boston, MA. This cooperative agreement 

will provide for data collection and 

analyses related to the effectiveness of 

State agencies in promoting community 

integrated employment for individuals 

with intellectual and developmental 

disabilities. The project will collect 

data, analyze, and report on the 

employment and economic status of 

individuals with intellectual and 

developmental disabilities including 

disaggregation of data related to specific 

demographic groups. The project will 

also make recommendations related to 

the standardization of data and 

reporting of employment outcomes. 

Project staff will also participate in 

collaborative efforts with ADD and other 

data collection projects to review and 

report on unmet needs in data 

collection, analyses, and reporting 

activities that would promote the selfdetermination, independence, 

productivity, and integration and 

inclusion of people with intellectual 

and developmental disabilities in all 

facets of community life. 

The University of Minnesota (The 

Research and Training Center), 

Minneapolis, MN. This cooperative 

agreement will provide for data 

collection, analyses, and reporting of 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 65495 

national and State statistics on public 

and private residential services for 

individuals with intellectual and 

developmental disabilities, including 

disaggregation of data related to specific 

demographic groups. The project will 

conduct analyses that describe the 

movement of individuals with 

intellectual and developmental 

disabilities from institutional to 

community settings. Project staff will 

also participate in collaborative efforts 

with ADD and other data collection 

projects to review and report on unmet 

needs in data collection, analyses, and 

reporting activities that would promote 

the self-determination, independence, 

productivity, and integration and 

inclusion of people with intellectual 

and developmental disabilities in all 

facets of community life. 

Contact for Further Information: 

Ophelia McLain, Supervisory Program 

Specialist, Administration on 

Developmental Disabilities, 370 

L’Enfant Promenade, SW., Mail Stop: 

HHH–405D, Washington, DC 20447. 

Telephone: 202–690–7025 E-mail: 

ophelia.mclain@acf.hhs.gov. 

Dated: October 14, 2010. 

Sharon Lewis, 

Commissioner, Administration on 

Developmental Disabilities. 

[FR Doc. 2010–26933 Filed 10–22–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental and 

Craniofacial Research; Interagency 

Pain Research Coordinating 

Committee; Call for Nominations 

The Department of Health and Human 

Services has created the Interagency 

Pain Research Coordinating Committee 

and is seeking nominations for this 

committee. As specified in Public Law 

111–148 (‘‘Patient Protection and 

Affordable Care Act’’) the Committee 

will: (a) Develop a summary of advances 

in pain care research supported or 

conducted by the Federal agencies 

relevant to the diagnosis, prevention, 

and treatment of pain and diseases and 

disorders associated with pain; (b) 

identify critical gaps in basic and 

clinical research on the symptoms and 

causes of pain; (c) make 

recommendations to ensure that the 

activities of the National Institutes of 

Health and other Federal agencies are 

free of unnecessary duplication of effort; 

(d) make recommendations on how best 

to disseminate information on pain care; 

and (e) make recommendations on how 

to expand partnerships between public 

entities and private entities to expand 

collaborative, cross-cutting research. 

Membership on the committee will 

include six (6) non-Federal members 

from among scientists, physicians, and 

other health professionals and six (6) 

non-Federal members of the general 

public who are representatives of 

leading research, advocacy, and service 

organizations for individuals with painrelated conditions. Members will serve 

overlapping three year terms. It is 

anticipated that the committee will meet 

at least once a year. 

The Department strives to ensure that 

the membership of HHS Federal 

advisory committees is fairly balanced 

in terms of points of view represented 

and the committee’s function. Every 

effort is made to ensure that the views 

of women, all ethnic and racial groups, 

and people with disabilities are 

represented on HHS Federal advisory 

committees and, therefore, the 

Department encourages nominations of 

qualified candidates from these groups. 

The Department also encourages 

geographic diversity in the composition 

of the Committee. Appointment to this 

Committee shall be made without 

discrimination on the basis of age, race, 

ethnicity, gender, sexual orientation, 

disability, and cultural, religious, or 

socioeconomic status. 

Nominations are due by COB 

November 26, 2010, and should be sent 

to Amy Adams, PhD, NIDCR/NIH, 31 

Center Drive, Room 5B55, MSC–2190, 

Bethesda MD 20892–2190, 

adamsamy@mail.nih.gov by either 

USPS mail or e-mail. Nominations 

should include contact information and 

a current curriculum vitae or resume. 

Dated: October 18, 2010. 

Amy Adams, 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health. 

[FR Doc. 2010–26937 Filed 10–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0529] 

Draft Guidance for Industry on 

Qualification Process for Drug 

Development Tools; 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 entitled ‘‘Qualification Process 

for Drug Development Tools.’’ This draft 

guidance describes the qualification 

process for drug development tools 

(DDTs) intended for potential use, over 

time, in multiple drug development 

programs. The draft guidance provides a 

framework for interactions between the 

Center for Drug Evaluation and Research 

(CDER) and DDT sponsors to support 

work towards qualification of an 

identified DDT and creates a mechanism 

for formal review of data by CDER to 

qualify the DDT and ensure that the 

evaluation is comprehensive and 

reliable. 

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 January 24, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft 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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 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 to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Shaniece Gathers, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4555, 

Silver Spring, MD 20993–0002, 301– 

796–2600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Qualification Process for Drug 

Development Tools.’’ In March 2006, 

FDA issued the ‘‘Critical Path 

Opportunities Report’’ and the ‘‘Critical 

Path Opportunities List.’’ In these 

reports, FDA described six key areas 

along the critical path to improved 

therapies, and a list of specific 

opportunities for advancement within 

these topic areas. The opportunities 

report noted that a new product 


emcdonald on DSK2BSOYB1PROD with NOTICES