27152 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

preventing or treating viral infections 

are claimed in the patents issued for this 

invention. 

Applications: 

• Prophylactic and/or therapeutic 

treatment for HIV infection. 

• Topical microbicide treatment to 

protect against HIV infection. 

• Imaging of HIV infected cells in 

tissues. 

Advantages: 

• High neutralization efficiency due 

to unique bifunctional binding 

characteristics. 

• Potentially minimally immunogenic 

or toxic (human sequences and possibly 

low treatment doses). 

• Broad neutralizing activity. 

• Mechanism of action less 

susceptible to resistance. 

Development Status: 

• Reproducible production and scaleup of chimeric protein has been 

demonstrated. 

• Potent and broad neutralization of 

genetically diverse HIV–1 clinical 

isolates was demonstrated. 

Market: The race to develop effective 

antiviral strategies against HIV infection 

is ongoing. The problems exhibited by 

conventional drugs (i.e. toxicity and 

resistance) have triggered the pursuit of 

alternative approaches to HIV/AIDS 

prevention and treatment. One of the 

new approaches is the development of 

neutralizing antibodies against the HIV 

envelope proteins. This approach has 

not yet yielded any commercially viable 

treatment. It is believed that the 

approach presented in the subject 

invention will circumvent many of the 

shortcomings of the existing drugs and 

other pursued approaches. If this 

approach is successful the commercial 

rewards will be huge because of the 

global magnitude of HIV epidemics. 

Inventor: Edward A. Berger (NIAID). 

Publication: B Dey, CS Del Castillo, 

EA Berger. Neutralization of human 

immunodeficiency virus type 1 by 

sCD4–17b, a single-chain chimeric 

protein, based on sequential interaction 

of gp120 with CD4 and coreceptor. J 

Virol. 2003 March;77(5):2859–2865. 

Patent Status: 

HHS Reference No. E–039–1999/0— 

• U.S. Patent No. 7,115,262, issued 03 

October 2006. 

• U.S. Application No. 11/535,957, 

filed 27 September 2006, published 18 

October 2007 as 20070243208. 

• Australian Patent No. 765218, 

issued 30 July 2003. 

• Applications pending in Canada, 

France, Germany, Great Britain, Italy, 

Japan, Spain. 

Licensing Status: Available for 

licensing. 

Licensing Contacts: Uri Reichman, 

Ph.D, MBA; 301–435–4616; 

ur7a@nih.gov; RC Tang, JD, LLM; 301– 

435–5031; tangrc@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID Office of Technology 

Development is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize ‘‘A Novel Chimeric 

Protein for Prevention and Treatment of 

HIV Infection.’’ Please contact Rick 

Williams at 301–402–0960 for more 

information. 

Dated: June 1, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–13284 Filed 6–5–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0217] 

Guidance for Industry on Medication 

Guides—Adding a Toll-Free Number 

for Reporting Adverse Events; 

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 

entitled ‘‘Medication Guides—Adding a 

Toll-Free Number for Reporting Adverse 

Events.’’ Beginning July 1, 2009, 

manufacturers of prescription drug 

products approved under the Federal 

Food, Drug, and Cosmetic Act (the act) 

that are required to have a Medication 

Guide must add a verbatim statement to 

their Medication Guides containing 

FDA’s toll-free number for reporting 

side effects. These manufacturers are 

also required to report to FDA that they 

have complied with this requirement. 

This guidance explains what statement 

to add to Medication Guides, where to 

add it, and how to notify the agency that 

such a statement has been added. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this 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. 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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Clark, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–5400, Nancy.Clark@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Medication Guides—Adding a TollFree Number for Reporting Adverse 

Events.’’ On September 27, 2007, the 

President signed into law the Food and 

Drug Administration Amendments Act 

(FDAAA) (Public Law 110–85). Among 

other things, FDAAA reauthorized the 

Best Pharmaceuticals for Children Act 

(BPCA) (Public Law 107–109). When 

enacted in 2001, the BPCA directed 

FDA to issue a final rule requiring the 

labeling of each human drug product for 

which an application is approved under 

section 505 of the act (21 U.S.C. 355) to 

include: (1) A toll-free number 

maintained by FDA for the purpose of 

receiving reports of adverse events 

regarding drugs and (2) a statement that 

the number is to be used for reporting 

purposes only, not to receive medical 

advice. The BPCA stated that the final 

rule must reach the broadest consumer 

audience and minimize the cost to the 

pharmacy profession. As required, FDA 

issued a proposed rule entitled ‘‘TollFree Number for Reporting Adverse 

Events on Labeling for Human Drug 

Products’’ (69 FR 21778, April 22, 

2004), which would require, among 

other things, that a side effects 

statement be included in FDA-approved 

Medication Guides for drug products 

approved under section 505 of the act. 

FDA received 22 comments on this 

proposed rule and was in the process of 

analyzing the comments and conducting 

research on consumer comprehension of 

the side effects statement when FDAAA 

was enacted. Section 502(f) of FDAAA 

stated that ‘‘the proposed rule * * * 

entitled ‘Toll-Free Number for Reporting 

Adverse Events on Labeling for Human 

Drug Products’ * * * shall take effect 

on January 1, 2008,’’ unless FDA issues 

a final rule before that date. FDA did not 

issue a final rule by January 1, 2008, so 


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Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 27153 

as mandated by FDAAA, the provisions 

of the proposed rule went into effect on 

that date. 

FDAAA mandated one change to the 

proposed rule. Section 502(f)(2) of 

FDAAA stated that the toll-free number 

proposed rule shall not apply to overthe-counter (OTC) drugs marketed with 

an application approved under section 

505 of the act (application OTC drug 

products) if these application OTC drug 

products meet certain labeling 

requirements. Because the agency’s 

rulemaking process was ongoing on 

January 1, 2008, an interim final rule 

was issued on January 3, 2008 (73 FR 

402) that codified the provisions of the 

proposed rule as modified by FDAAA. 

The interim final rule stated that FDA 

anticipated that affected entities would 

need time to update labeling and 

systems to comply with the new 

requirements and that FDA intended to 

exercise its enforcement discretion and 

not take action to enforce the toll-free 

number requirements in the interim 

final rule until January 1, 2009. The 

interim final rule also stated that the 

agency planned to complete research 

begun on the proposed labeling 

statements and would issue a final rule 

taking into account the results of that 

research. In the Federal Register of 

October 28, 2008 (73 FR 63886), FDA 

issued a final rule with an effective date 

of November 28, 2008, and a 

compliance date of July 1, 2009. The 

agency is publishing this guidance to 

assist manufacturers in complying with 

the final rule. 

This level 1 guidance is being issued 

for immediate implementation 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

FDA has determined that prior public 

participation is not feasible or 

appropriate because the side effects 

statement is required by Congress and 

the compliance deadline for its 

inclusion in Medication Guides is July 

1, 2009 (21 CFR 10.115(g)(2)). If 

comments are received on this level 1 

guidance, FDA will review the 

comments and revise the guidance if 

appropriate. The guidance represents 

the agency’s current thinking on adding 

a toll-free number to Medication Guides 

and reporting this to the agency. 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. The Paperwork Reduction Act of 

1995 

The required side effects statement is 

not subject to the Office of Management 

and Budget (OMB) review under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501–3520) because it is 

‘‘originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public’’ and 

is not considered a collection of 

information under the PRA (5 CFR 

1320.3(c)(2)). The guidance on notifying 

FDA in the drug’s annual report that the 

side effects statement has been added to 

the drug’s Medication Guide is covered 

by previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR 314.70(d) (changes to an approved 

application to be described in an annual 

report) and 314.81(b)(2)(iii)(c) (a 

summary of labeling changes that have 

been made since the last annual report) 

have been approved under OMB control 

number 0910–0001 for human drugs. 

III. Comments 

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: June 1, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13273 Filed 6–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Maternal Child Health Bureau, Healthy 

Start Eliminating Disparities in 

Perinatal Health 

AGENCY: Health Resources and Services 

Administration (HRSA), U.S. 

Department of Health and Human 

Services. 

ACTION: Notice of Non-competitive 

Supplemental Funding to Northern 

Manhattan Perinatal Partnership. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

issuing non-competitive supplemental 

funding under the Maternal Child 

Health Bureau, Healthy Start 

Eliminating Disparities in Perinatal 

Health program to ensure that the 

Northern Manhattan Perinatal 

Partnership (NMPP), the primary 

provider of prenatal services in Central 

Harlem, can continue to provide much 

needed services to help stem the rise in 

and ultimately reduce the Infant 

Mortality Rate (IMR) in the affected 

service area. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: 

Northern Manhattan Perinatal 

Partnership. 

Amount of the Non-Competitive 

Supplemental Funding: $510, 417. 

Project Period: The original project 

period for this grant is through May 31, 

2009. 

Period of Supplemental Support: June 

1, 2009 through January 31, 2010. 

Authority: This activity is under the 

authority of the Public Health Service 

Act, Section 33OH. 

Catalogue of Federal Domestic 

Assistance Number: 93.926. 

Justication for Non-Competitive 

Supplemental Funding 

Northern Manhattan Perinatal 

Partnership (NMPP), known as Central 

Harlem Healthy Start, has historically 

been the primary provider of prenatal 

services in Central Harlem and has been 

highly effective in reducing the high 

rate of infant morality (IMR) in that 

project/service area. As a consequence 

of NMPP’s leadership and collaborated 

efforts with other providers in the 

community, the IMR has declined 

significantly in Central Harlem since the 

initiation of the project in 1990 when it 

was 27.7 infant deaths per 1,000 live 

births. By 2001, the IMR had dropped to 

13.1 infant deaths per 1,000 live births, 

54% less than the 1990 rate. The IMR 

in Central Harlem from 2002 to 2004 

showed a decline from the previous 

years; however, there were fluctuations 

in the rate of decline in the community. 

The IMR was at a low of 6.2% in 2002 

and increased to 7.3% in 2003, and then 

in 2004, decreased to 5.1%. The 

apparent trend in the following two 

years saw a steady increase to 7.4% for 

2005 and 11.2% for 2006. An additional 

indicator of this trend is the escalating 

IMR for teen births which saw an 

increase in the 3 year average from 


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