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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27154 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

2002–2004 of 5.93% increase to 12.54% 

for 2005–2007. 

The reduction in the earlier years IMR 

(2002–2004) for Central Harlem made 

them ineligible for the FY 2009 Healthy 

Start Eliminating Disparities Open 

competition. To be eligible, the IMR for 

the service area had to be 1.5 times the 

national average for the period of 2002– 

2004 or 10.35. In FY 2010 there will be 

another Healthy Start Eliminating 

Disparities Open competition and 

grantees will be required to the use the 

most recently available IMR data (2004– 

2006 or 2005–2007) to compete. To be 

eligible for the competition, grantees 

will have to have an IMR that is 1.5 

times the national average for the 

project area for either 2004–2006 or 

2005–2007. Data supplied the New York 

City Bureau Statistics indicates that 

Central Harlem would be eligible for 

this competition because they have 

12.54% IMR for teen births for 2005– 

2007. 

The award of non-competitive 

supplemental funding will enable 

NMPP to provide much need services in 

Central Harlem. Given the current 

economic situation and the rising IMR 

rate in the project area, the loss of this 

experienced provider of health services 

would be devastating and would 

contribute to the rise in infant deaths in 

Central Harlem, NMPP is the primary 

provider of comprehensive communitybased perinatal services and the only 

Healthy Start site serving the project 

area. The project’s dedication and 

commitment to the residents of Harlem 

since 1999 could not be replaced 

another community based provider. 

FOR FURTHER INFORMATION CONTACT: John 

McGovern, Public Health Analyst, 

Division of Healthy Start and Perinatal 

Services, Maternal and Child Health 

Bureau, HRSA, Room 18–12, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

MD 20857; phone 301–443–5805; E-mail 

jmcgovern@hrsa.gov. 

Dated: May 29, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–13279 Filed 6–5–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel Competitive Revision—ARRA Funds. 

Date: June 11, 2009. 

Time: 1:45 p.m. to 3:45 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892. (Telephone 

Conference Call). 

Contact Person: Rebecca H Johnson, PhD, 

Scientific Review Administrator, Office of 

Scientific Review, National Institute of 

General Medical Sciences, National Institutes 

of Health, Natcher Building, Room 3AN18C, 

Bethesda, MD 20892. 301–594–2771. 

johnsonrh@nigms.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.701, ARRA 

Related Biomedical Research and Research 

Support Awards, National Institutes of 

Health, HHS) 

Dated: June 1, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13199 Filed 6–5–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel—Program Project. 

Date: July 10, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIH, Democracy II, 6701 Democracy 

Plaza II, 200, Bethesda, MD 20892, (Virtual 

Meeting). 

Contact Person: John K. Hayes, PhD, 

Scientific Review Officer, 6707 Democracy 

Boulevard, Suite 959, Bethesda, MD 20892, 

301–451–3398, hayesj@mail.nih.gov. 

Dated: June 1, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13282 Filed 6–5–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel. Animal Models of Infectious 

Diseases 1. 

Date: June 29–July 1, 2009. 

Time: 8 a.m. to 7 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Crowne Plaza—Silver Spring, 8777 

Georgia Avenue, Silver Spring, MD 20910. 

Contact Person: Tracy A. Shahan, PhD, 

MBA, Scientific Review Officer, Scientific 

Review Program, NIH/NIAID/DHHS, Room 

3121, 6700B Rockledge Drive, MSC 7616, 


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