Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices 19095 

FOR FURTHER INFORMATION CONTACT: 

Patricia Y. Love, Office of Combination 

Products (HFG–3), Food and Drug 

Administration, 15800 Crabbs Branch 

Way, Rockville, MD 20855, 301–427– 

1934. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance document entitled 

‘‘Technical Considerations for Pen, Jet, 

and Related Injectors Intended for Use 

with Drugs and Biological Products.’’ 

FDA is providing this draft guidance 

document to assist industry in 

developing technical and scientific 

information to support a marketing 

application for a pen, jet, or related 

injector device. The marketing 

application would typically be a 510(k) 

or a PMA application for the injector 

alone. For a combination product that 

includes the injector, the marketing 

application would typically be an NDA 

or a BLA. For purposes of this guidance, 

the term ‘‘injector’’ includes, but is not 

limited to, jet injectors, pen injectors, 

piston syringes, needle-free injectors, 

mechanically operated injectors, and 

injectors with computerized or 

electronic elements. 

II. Significance of Guidance 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on ‘‘Technical Considerations for Pen, 

Jet, and Related Injectors Intended for 

Use with Drugs and Biological 

Products.’’ 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. 

III. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

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 

of information in 21 CFR part 807 have 

been approved under OMB control 

number 0910–0120. The collections of 

information in 21 CFR part 814 have 

been approved under OMB control 

number 0910–0231. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information 21 CFR part 601 have been 

approved under OMB control number 

0910–0338. 

IV. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

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 the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/oc/combination/ or 

http://www.regulations.gov. 

Dated: April 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9519 Filed 4–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Healthy Start Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: General notice. 

BACKGROUND: This notice 

supplements the 2008 HRSA 

announcement (HRSA 09–130 and 09– 

131) of the availability of fiscal year 

(FY) 2009 funding for new and 

competing continuation applications for 

Healthy Start. Healthy Start, authorized 

under Section 330H of the Public Health 

Service Act, strengthens communities to 

effectively address the causes of infant 

mortality, low birth weight and other 

poor perinatal outcomes for women and 

infants. Recently, new guidance became 

available with regard to funding FY 

2009 Healthy Start programs. 

SUMMARY: Following the Senate 

Appropriations Committee’s 

recommendation, the Health Resources 

and Services Administration (HRSA) 

will give funding preference during the 

FY 2009 competition to current and 

former Healthy Start grantees with 

expiring or recently expired project 

periods. 

This new guidance continues 

guidance from Congress that began in 

FY 2002. During the FY 2001 Healthy 

Start Initiative: Eliminating Disparities 

in Perinatal Health Open Competition, 

several grantees were approved but 

unfunded. Subsequently, Congress 

noted that the phasing out of these 

grants would cause a major disruption 

in services for pregnant women and 

infants in communities with high infant 

mortality and poor perinatal outcomes. 

For FY 2002, Congress, under The 

Consolidated Appropriations Act of 

2002 (Pub. L. 107–116), Departments of 

Labor, Health and Human Services, and 

Education, and Related Agencies 

Appropriations Act, 2002, allocated 

additional funding for these grants but 

stipulated that these new funds were to 

be used to ‘‘give preference to current 

and former grantees with expiring or 

recently expired project periods, 

including grantees that did not receive 

funding but whose grant applications 

were approved but not funded during 

fiscal year 2001.’’ HRSA honored this 

request and funded the remaining 

approved unfunded grantee applicants 

in February 2002. 

This preference language has 

continued in each Healthy Start 

competition since 2002. With the 2005 

Healthy Start competition, Congress, 

through The Consolidated 

Appropriations Act (Pub. L. 108–447, 

HR 108–792), once again gave 

‘‘preference to current and former 

grantees with expiring or recently 

expired project periods.’’ In 2006, the 

Conference report HR 109–200, 

accompanying the Departments of 

Labor, Health and Human Services, 

Education, and Related Agencies 

Appropriation Act, 2006, (Pub. L. 109– 

149, HR 109–300) continued the 

preference language. This year’s FY 

2009 Senate Appropriations Committee 

report states that ‘‘The healthy start 

initiative was developed to respond to 

persistently high rates of infant 

mortality in this Nation. The initiative 

was expanded in fiscal year 1994 by a 

special projects program, which 

supported an additional seven urban 

and rural communities to implement 

infant mortality reduction strategies and 

interventions. The Children’s Health 

Act of 2000 fully authorized this 

initiative as an independent program. 

The Committee urges HRSA to give 

preference to current and former 

grantees with expiring or recently 

expired project periods.’’ (S. Rept. 110– 

410) 


pwalker on PROD1PC71 with NOTICES
19096 Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Maribeth Badura, Director, Division of 

Healthy Start and Perinatal Services, 

Maternal and Child Health Bureau, 

HRSA, Room 18–12, Parklawn Building, 

5600 Fishers Lane, Rockville, Maryland 

20857; telephone (301) 443–0543; 

e-mail MBadura@hrsa.gov. 

Dated: April 21, 2009. 

Marcia K. Brand, 

Deputy Administrator. 

[FR Doc. E9–9517 Filed 4–24–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0430] (formerly 

Docket No. 2007D–0166) 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Guidance for Industry on ‘‘Target 

Animal Safety for Veterinary 

Pharmaceutical Products,’’ VICH GL43; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

(#185) entitled ‘‘Target Animal Safety 

for Veterinary Pharmaceutical 

Products,’’ VICH GL43. The purpose of 

this harmonized guidance is to provide 

recommendations regarding target 

animal safety (TAS) evaluation for 

regulatory submission of an 

Investigational Veterinary 

Pharmaceutical Product (IVPP), which 

is appropriate for determining the safety 

of an IVPP in the target animal. The 

guidance includes recommendations on 

including identification of target organs, 

where possible, and confirmation of 

margin of safety, using the minimum 

number of animals appropriate for the 

studies. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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 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: 

Steven Vaughn, Center for Veterinary 

Medicine, (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 (VICH) 

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. Guidance on Target Animal Safety 

for Veterinary Pharmaceutical Products 

In the Federal Register of May 18, 

2007 (72 FR 28058), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Draft Guidance for Industry on 

Target Animal Safety for Veterinary 

Pharmaceutical Products,’’ which gave 

interested persons until June 18, 2007, 

to comment on the draft guidance. FDA 

received a few comments on the draft 

guidance and those comments as well as 

those received by other VICH member 

regulatory agencies were considered as 

the guidance was finalized. Based on 

the comments received, the VICH Expert 

Working Group on Target Animal Safety 

clarified the guidance’s 

recommendations regarding the 

development and conduct of TAS 

studies. In particular, the Expert 

Working Group revised the sections 

addressing necropsy and histopathology 

examinations and mammary gland 

studies to clarify the recommendations 

regarding these topics. At a meeting 

held in July 2008, the VICH Steering 

Committee endorsed the final guidance 

for industry, (VICH GL43). The guidance 

announced in this notice finalizes the 

draft guidance dated May 18, 2007. 

This guidance document is intended 

to cover TAS evaluation for any IVPP 

used in the following species: Bovine, 

ovine, caprine, feline, canine, porcine, 

equine, and poultry (chickens and 

turkeys). The recommendations in this 

guidance may not be appropriate for 

registration by national or regional 

authorities of products for use in minor 

species or minor uses. The guidance 

does not provide information for the 

design of TAS studies in other species, 

including aquatic animals. For other 

species and for minor uses, TAS studies 

should be designed following national 

or regional guidance. 

III. Significance of Guidance 

This guidance document, developed 

under the VICH process, has been 

revised to conform to FDA’s good 

guidance practices regulation (21 CFR 

10.115). For example, the document has 

been designated ‘‘guidance’’ rather than 


pwalker on PROD1PC71 with NOTICES