35872 Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 

environmental assessment by August 

20, 2009. 

ADDRESSES: Submit written comments 

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. 

FOR FURTHER INFORMATION CONTACT: 

Blondell Anderson, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1304. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))), 

notice is given that a food additive 

petition (FAP 9A4778) has been filed by 

Ajinomoto Co., Inc., c/o Ajinomoto 

Corporate Services LLC, 1120 

Connecticut Ave. NW., suite 1010, 

Washington, DC 20036. The petition 

proposes to amend the food additive 

regulations in part 172 Food Additives 

Permitted For Direct Addition to Food 

for Human Consumption (21 CFR part 

172) to provide for the safe use of N-[N- 

[3-(3-hydroxy-4-methoxyphenyl) 

propyl-a-aspartyl]-L-phenylalanine 1- 

methyl ester, monohydrate (CAS Reg. 

No. 714229–20–6) for use as a nonnutritive sweetener in tabletop 

applications and powdered beverage 

mixes. 

The potential environmental impact 

of this petition is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see DATES and ADDRESSES) for public 

review and comment. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the agency finds 

that an environmental impact statement 

is not required, and this petition results 

in a regulation, the notice of availability 

of the agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 

Dated: July 10, 2009. 

Laura M. Tarantino, 

Director, Office of Food Additive Safety, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. E9–17250 Filed 7–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Health and Nutrition 

Examination Survey (NHANES) Stored 

Biologic Specimens: Guidelines for 

Proposals to Use Samples and 

Proposed Cost Schedule 

ACTION: Notice and request for 

comments. 

SUMMARY: The National Health and 

Nutrition Examination Survey 

(NHANES) is a program of periodic 

surveys conducted by the National 

Center for Health Statistics (NCHS) of 

the Centers for Disease Control and 

Prevention (CDC). Examination surveys 

conducted since 1960 by NCHS, have 

provided national estimates of health 

and nutritional status of the United 

States civilian non-institutionalized 

population. To add to the large amount 

of information collected for the purpose 

of describing the health of the 

population in the most recent survey, 

serum, urine and limited plasma 

samples were collected and stored for 

future research projects. Specimens are 

currently available from NHANES III 

(conducted from 1988–1994) and from 

NHANES 1999–2008. In 1999, NHANES 

became a continuous survey with data 

release every two years. Specimens are 

available from two year survey cycles 

after the demographic file has been 

released to the public. Participants in 

the survey that began in 1999 signed a 

separate consent document agreeing to 

specimen storage allowing their biologic 

specimens to be used for approved 

research projects. 

Specimens are stored in two 

Specimen Banks. Surplus samples that 

were initially used for laboratory assays 

included in the surveys, have since been 

stored at ¥70 °C and have been through 

at least two freeze-thaw cycles. They are 

stored at a commercial repository under 

contract to NCHS. In addition, on 

average, six vials of sera were also 

stored in vapor-phase liquid nitrogen at 

the CDC and ATSTR Specimen 

Packaging, Inventory and Repository 

(CASPIR) Repository in Lawrenceville, 

GA. These specimens have not 

undergone a freeze-thaw cycle. The 

CASPIR Repository is considered a longterm repository for the NHANES 

specimens. NCHS is making both of 

these collections available for research 

proposals. The research proposals that 

can use the surplused specimens will 

receive higher priority. Proposals that 

request the specimens in CASPIR need 

to justify the use of the unthawed 

specimens. 

The purpose of this notice is to 

request comments on this program and 

the proposed cost schedule. After 

consideration of comments submitted, 

CDC will finalize and publish the cost 

schedule and accept proposals for use of 

the NHANES stored biologic samples. 

Please go to http://www.cdc.gov/nchs/ 

nhanes/proposal_guidelines.htm for 

final proposal guidelines. 

All interested researchers are 

encouraged to submit proposals. No 

funding is provided as part of this 

solicitation. Samples will not be 

provided to those projects requiring 

funding until the project has received 

funds. Approved projects that do not 

obtain funding will be canceled. A more 

complete description of this program 

follows. 

DATES: 

• Comment Receipt Date: August 20, 

2009. 

• Invitation to Submit Proposals: Can 

be submitted on an ongoing basis 

• Scientific Review Date: Within two 

months of proposal submission. 

• Institutional Review Date: Within 

one month of final proposal acceptance. 

• Anticipated distribution of samples: 

one month after IRB approval. 

ADDRESSES: To send comments and to 

request information, contact: Dr. 

Geraldine McQuillan, Division of Health 

and Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, Room 

4204, Hyattsville, MD 20782, 

Phone: 301–458–4371, 

Fax: 301–458–4028, 

E-mail: gmm2@cdc.gov. 

Internet: http://www.cdc.gov/nchs/ 

about/major/nhanes/serum1b.htm. 

Authority: Sections 301,306 and 308 of the 

Public Health Service Act (42 U.S.C. 241, 

242k and 242M). 

SUPPLEMENTARY INFORMATION: 

The goals of NHANES are: (1) To 

estimate the number and percent of 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 35873 

persons in the U.S. population and 

designated subgroups with selected 

diseases and risk factors; (2) to monitor 

trends in the prevalence, awareness, 

treatment and control of selected 

diseases; (3) to monitor trends in risk 

behaviors and environmental exposures; 

(4) to analyze risk factors for selected 

diseases; (5) to study the relationship 

between diet, nutrition and health; (6) to 

explore emerging public health issues 

and new technologies; and, (7) to 

establish and maintain a national 

probability sample of baseline 

information on health and nutrition 

status. 

Specimens are available from the 

third National Health and Nutrition 

Examination Survey (NHANES III) and 

the continuous NHANES that started in 

1999. Approximately 30,000 individuals 

were examined in NHANES III which 

began in the fall of 1988, and ended in 

the fall of 1994. This survey can be 

analyzed in two phases. Phase 1 was 

conducted from October 1988 to 

October 1991 and Phase 2 began 

October 1991 and ended October 1994. 

Though participants consented to 

storing samples of their blood for future 

testing only research projects that 

include results that are judged not to 

have clinical significance for 

participants will be accepted. Clinical 

significance is defined by the following 

criteria: 

• The findings are valid and done by 

a CLIA-certified laboratory, and 

• The findings may have significant 

implications for the subjects’ health 

concerns, and 

• A course of action to ameliorate, or 

treat the concerns is readily available. 

There are approximately 368,473 serum 

samples available for research proposals 

using NHANES III samples. An aliquot 

of the samples will be reserved in 

perpetuity. See: http://www.cdc.gov/ 

nchs/about/major/nhanes/nh3data.htm 

for more information on NHANES III. 

Beginning in 1999, NHANES became 

a continuous, annual survey with 

examination of approximately 5,000 

individuals a year and data release 

every two years. Proposed research 

projects and samples requested must 

come from this two-year design (i.e. 

request must be for 1999–2000 samples 

or 2001–2002, etc.). Samples from a 

single year of the survey will not be 

provided for research projects, but 

multiple two-year cycles may be 

requested. There are approximately 

329,420 serum samples, 55,411 urine 

samples and 79,604 plasma samples 

available for research proposals. An 

aliquot of the samples will be reserved 

in perpetuity. For details of the 

sampling design see the Analytic 

Guidelines at: http://www.cdc.gov/nchs/ 

about/major/nhanes/nhanes2003–2004/ 

analytical_guidelines.htm. 

Starting in 1999 to 2008 survey 

participants were informed in the 

consent document for future laboratory 

analysis that they would not receive the 

results from these studies. Therefore, 

only research projects that propose 

laboratory results that do not have 

clinical significance (see definition of 

clinical relevance above) to an 

individual will be accepted by NCHS. 

Clinical significance of a laboratory test 

will be judged by the NHANES Medical 

Officer, but the researcher should 

address this in the research proposal. 

See http://www.cdc.gov/nchs/about/ 

major/nhanes/nhanes2007–2008/ 

current_nhanes_07_08.htm for a copy of 

the current consent document. 

All proposals for use of NHANES 

samples will be evaluated by a technical 

panel for scientific merit and by the 

NHANES Ethics Review Board (ERB) for 

any potential human subjects concerns. 

The NHANES ERB will review the 

proposal even if the investigator has 

received approval by their institutional 

review panel. 

To determine if this limited resource 

should be used in the proposed projects, 

a Technical Panel will evaluate the 

public health significance and scientific 

merit of the proposed research. 

Scientific merit will be judged as to the 

scientific, technical or medical 

significance of the research, the 

appropriateness and adequacy of the 

experimental approach, and the 

methodology proposed to reach the 

research goals. See ‘Criteria for 

Technical Evaluation of Proposals’ 

below. The proposal should outline how 

the results from the laboratory analysis 

will be used. Because NHANES is a 

complex, multistage probability sample 

of the national population, the 

appropriateness of the NHANES sample 

to address the goals of the proposal will 

be an important aspect of scientific 

merit. The survey oversamples the two 

largest race/ethnic minority groups, 

non-Hispanic blacks and Mexican 

Americans along with other subgroups 

of the population. Sampling weights are 

therefore used to make national 

estimates of frequencies. The use of 

weights, sampling frame and methods of 

assessment of variables included in the 

data are likely to affect the proposed 

research. The Technical Panel will 

review the analysis plan and evaluate 

whether the proposal is an appropriate 

use of the NHANES population. The 

Technical Panel will also assure that the 

proposed project does not go beyond 

either the general purpose for collecting 

the samples in the survey, or of the 

specific stated goals of the proposal. 

Investigators are encouraged to review 

the NHANES data, survey documents, 

manuals and questionnaires at: http:// 

www.cdc.gov/nchs/about/major/ 

nhanes/nhanes99–02.htm or for 

NHANES III: http://www.cdc.gov/nchs/ 

about/major/nhanes/nh3data.htm. 

Procedures for Proposals: All 

investigators (including CDC 

investigators) must submit a proposal 

for use of NHANES specimens. 

Proposals are limited to a maximum 

of 10 single-spaced typed pages, 

excluding figures and tables, using 10 

cpi type density. The cover of the 

proposal should include the name, 

address, and phone number and E-mail 

address of the principal investigator (PI) 

and the name of the institution where 

the laboratory analysis will be done. All 

proposals should be E-mailed to 

gmm2@cdc.gov. Proposals must include 

a cover page with the title of the 

proposal and the name, address, phone 

number and E-mail address of all 

investigators. Proposals from CDC 

investigators must also include 

investigators’ scientific ethic 

verification number. 

The following criteria will be used for 

technical evaluation of proposals: 

Proposals should include the 

following information: 

(1) Specific Aims: List the broad 

objectives; describe concisely and 

realistically what the research is 

intended to accomplish, and state the 

specific hypotheses to be tested. 

NHANES is designed to provide 

prevalence estimates of diseases or 

conditions that are expected to affect 

between 5–10 percent of the population. 

Research proposals that expect much 

lower prevalence estimates need to 

provide more detail on why specimens 

from NHANES are needed for the 

project and provide details on how 

these data will be analyzed. 

(2) Background and Public Health 

Significance: Describe the public health 

significance, scientific merit and 

practical utility of the assay. Briefly 

describe in 1–2 pages the background of 

the proposal, identifying gaps in 

knowledge that the project is intended 

to fill. State concisely the importance of 

the research in terms of the broad, longterm objectives and public health 

relevance including a discussion of how 

the results will affect public health 

policy or further scientific knowledge. 

The proposal should justify the need for 

specimens that are representative of the 

U.S. population. The proposer should 

convey how the results will be used and 

the relationship of the results to the data 

already collected in NHANES. The 


jlentini on DSKJ8SOYB1PROD with NOTICES
35874 Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 

proposer should include an analysis 

plan. The analyses ought to be 

consistent with the NHANES mission 

and the health status variables. 

(3) Research Design and Methods: 

Describe the research design and the 

procedures to be used. A detailed 

description of laboratory methods 

including validity and reliability must 

be included with references. The 

volume of specimen and number of 

samples requested must be specified. 

Adequate methods for handling and 

storage of samples must also be 

addressed. The laboratory must 

demonstrate expertise in the proposed 

laboratory test including the capability 

for handling the workload requested in 

the proposal. The proposal should also 

include a justification for determination 

of sample size or a power calculation. If 

the researcher is requesting a subsample of specimens, a detailed 

description and justification, must be 

given. The researcher must describe 

how this sub-sample will be re-weighted 

to provide national estimates. The 

program will evaluate the study design 

and analysis plan in the proposal to 

determine whether the project is 

consistent with the design of the 

NHANES survey. Sub-samples are less 

useful to the research community when 

the data are released in the public 

domain, so such requests will receive a 

lower priority for the specimens. 

Restricting a research proposal to 

demographic categories that are design 

variables for the survey is encouraged if 

laboratory testing must be restricted. 

(4) Clinical Significance or results: 

Since the consent document for 

specimen storage and continuing 

studies states that individual results 

will not be provided, the clinical 

significance of the proposed laboratory 

test should be addressed. The proposal 

should include a discussion of the 

potential clinical significance of the 

results and whether there is definitive 

evidence that results of the test would 

provide grounds for medical 

intervention even if many years have 

passed since the examination of the 

participant and collection of the sample. 

Any test with results that should be 

reported to a participant should be 

considered for inclusion in the 

concurrent survey, and is not 

appropriate for testing on the stored 

samples. 

(5) Qualification: Provide a brief 

description of the Principal 

Investigator’s expertise in the proposed 

area should be provided, including 

publications in this area within the last 

three years. A representative sample of 

earlier publications may be listed as 

long as this section does not exceed two 

pages. 

(6) Period of performance: Specify the 

project period. Substantial progress 

must be made in the first year, and the 

project should be completed in two 

years. If additional time is needed for 

the research project a detailed 

justification with a timeline should be 

included. The investigator should 

address his/her ability to comply with 

this timeline or request and justify 

additional time for the project. Return of 

the specimens will be requested if 

progress is not made in the project at the 

end of the second year. Refund of 

payment for the specimens will not be 

returned in this situation. At the end of 

the project period, any unused samples 

must be returned to the NHANES 

Specimen Bank or discarded. The NCHS 

Project Officer must be consulted about 

the disposition of the samples. 

(7) Funding: Include the source and 

status of the funding to perform the 

requested laboratory analysis should be 

included. Investigators will be 

responsible for the cost of processing 

and shipping the samples. The cost per 

specimen is $6.50. The basis for the cost 

structure is in the last section of this 

document. Reimbursement for the 

samples will be collected before the 

samples are released. 

Submission of Proposals: Proposals 

can be submitted in MS Word format by 

e-mail to: Dr. Geraldine McQuillan, 

Division of Health and Nutrition 

Examination Surveys, National Center 

for Health Statistics, Centers for Disease 

Control and Prevention, 3311 Toledo 

Road, Room 4204, Hyattsville, MD 

20782, Phone: 301–458–4371 Fax: 301– 

458–4028, e-mail: gmm2@cdc.gov. 

Approved Proposals: Approved 

projects will be provided specimens on 

receipt of a signed Materials Transfer 

Agreement (MTA) and a check (written 

to The Centers for Disease Control and 

Prevention) for the cost of the 

specimens. All laboratory results 

obtained from the samples will be sent 

back to NCHS to be linked to the 

sequence number that is the linking 

identifier on the public use files. All 

files will undergo disclosure review at 

NCHS. Within 90 days of the return of 

the data to NCHS these data may be 

released to the public. 

Agency Agreement: A formal signed 

agreement in the form of a Materials 

Transfer Agreement (MTA) with 

individuals who have projects approved 

will be completed before the release of 

the samples. This agreement will 

contain the conditions for use of the 

samples as stated in this document and 

as agreed upon by the investigators and 

CDC. 

Progress Reports: Brief progress 

reports will be submitted annually. This 

will be the basis for the NHANES ERB 

continuation reports that are required 

annually. 

Disposition of Results and Samples: 

No samples provided can be used for 

any purpose other than those 

specifically requested in the proposal 

and approved by the Technical Panel 

and the NHANES ERB. No sample can 

be shared with others, including other 

investigators, unless specified in the 

proposal and so approved. Any unused 

samples must be returned to the 

NHANES Specimen Bank or disposed of 

upon completion of the approved 

project. These results, once returned to 

NCHS, will be part of the public 

domain. The proposer will have 90 days 

for quality control review of the data 

before public release. 

Proposed Cost Schedule for Providing 

NHANES Specimens: A nominal 

processing fee of $8.50 is proposed for 

each sample received from the NHANES 

Specimen Bank. The costs include both 

the collection, storage and processing of 

the specimens along with the review of 

proposals and the preparation of the 

data files. These costs were based on an 

assumption that NCHS will receive and 

process eight proposals in a year, each 

requesting 5,000 samples as shown in 

the table below. 

The materials listed are for the 

recurring laboratory costs to dispense 

and prepare the samples during 

collection and for shipping; the 

computer software needed for the 

preparation of the data files and for the 

release of the data along with 

documentation on the NHANES Web 

page. Labor costs are based on a 

proposal administrator and computer 

programmers at NCHS to prepare the 

data files. The storage and pulling fees 

include the costs for the NHANES 

repository. 

Total costs Cost per 

vial 

Labor ............................................. $1.15 

Collection Storage ........................ 4.10 

Pulling specimens ......................... 1.04 

Shipping ........................................ 0.32 

Subtotal ......................................... 6.61 

CDC/FMO support (9%) ............... 0.59 

Subtotal ................................. 7.20 

NCHS support (18%) .................... 1.30 

Total ....................................... 8.50 

Comments are solicited on the 

proposed cost schedule. Comments are 

due by: August 20, 2009. 

Send Comments and Requests for 

Information to: Dr. Geraldine 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 35875 

McQuillan, Division of Health and 

Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, Room 

4204, Hyattsville, MD 20782, Phone: 

301–458–4371; Fax: 301–458–4028, email: gmm2@cdc.gov. 

Tanja Popovic, 

Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–17267 Filed 7–20–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0309] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Draft Guidance for Industry on 

Bracketing and Matrixing Designs for 

Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products (VICH GL45); 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 (#198) entitled ‘‘Draft Guidance 

for Industry on Bracketing and 

Matrixing Designs For Stability Testing 

of New Veterinary Drug Substances and 

Medicinal Products,’’ VICH GL45. 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 guidance is an annex 

to a VICH guidance entitled ‘‘Stability 

Testing of New Veterinary Drug 

Substances and Medicinal Products 

(Revision),’’ VICH GL3(R), that 

published in the Federal Register of 

November 23, 2007 (72 FR 65751). This 

draft VICH guidance document is 

intended to provide guidance on the 

application of reduced designs (i.e., 

bracketing and matrixing) for stability 

studies conducted in accordance with 

the principles outlined in VICH GL3(R). 

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 

written or electronic comments on the 

draft guidance by August 20, 2009. 

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. 

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. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Dennis Bensley, Center for Veterinary 

Medicine (HFV–140), Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–276–8268, email: dennis.bensley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (#198) 

entitled ‘‘Draft Guidance for Industry on 

Bracketing and Matrixing Designs for 

Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products,’’ VICH GL45. 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, 

European Medicines Evaluation Agency, 

European Federation of Animal Health, 

Committee on Veterinary Medicinal 

Products, the U.S. 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 Bracketing and 

Matrixing Designs for Stability Testing 

The VICH Steering Committee held a 

meeting on February 11, 2008, and 

agreed that the draft guidance document 

entitled ‘‘Draft Guidance for Industry on 

Bracketing and Matrixing Designs for 

Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products,’’ VICH GL45 should be made 

available for public comment. This draft 

VICH guidance document provides 

guidance on bracketing and matrixing 

study designs. Specific principles are 

defined in this guidance for situations 

in which bracketing or matrixing can be 

applied. This document is intended to 

address recommendations on the 

application of bracketing and matrixing 

to stability studies conducted in 

accordance with principles outlined in 

the VICH GL3(R), ‘‘Stability Testing of 

New Veterinary Drug Substances and 

Medicinal Products (Revision).’’ FDA 

and the VICH Expert Quality Working 

Group will consider comments about 

the draft guidance document. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 


jlentini on DSKJ8SOYB1PROD with NOTICES