10924 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 

States 

Estimated state 

median income for 

a four-person 

family1

60 Percent of estimated state median income for a 

four-person 

family 2 3

Missouri ........................................................................................................................................................ 66,939 40,163 

Montana ....................................................................................................................................................... 62,353 37,412 

Nebraska ...................................................................................................................................................... 69,854 41,912 

Nevada ......................................................................................................................................................... 68,646 41,188 

New Hampshire ........................................................................................................................................... 88,625 53,175 

New Jersey .................................................................................................................................................. 97,326 58,396 

New Mexico ................................................................................................................................................. 53,041 31,825 

New York ..................................................................................................................................................... 78,061 46,837 

North Carolina .............................................................................................................................................. 64,591 38,755 

North Dakota ................................................................................................................................................ 67,183 40,310 

Ohio ............................................................................................................................................................. 71,063 42,638 

Oklahoma ..................................................................................................................................................... 57,247 34,348 

Oregon ......................................................................................................................................................... 67,605 40,563 

Pennsylvania ................................................................................................................................................ 75,161 45,097 

Rhode Island ................................................................................................................................................ 83,241 49,945 

South Carolina ............................................................................................................................................. 61,494 36,896 

South Dakota ............................................................................................................................................... 64,930 38,958 

Tennessee ................................................................................................................................................... 61,581 36,949 

Texas ........................................................................................................................................................... 62,358 37,415 

Utah ............................................................................................................................................................. 65,460 39,276 

Vermont ....................................................................................................................................................... 73,550 44,130 

Virginia ......................................................................................................................................................... 81,919 49,151 

Washington .................................................................................................................................................. 77,676 46,606 

West Virginia ................................................................................................................................................ 56,430 33,858 

Wisconsin ..................................................................................................................................................... 75,111 45,067 

Wyoming ...................................................................................................................................................... 72,788 43,673 

Note: FFY 2010 covers the period of October 1, 2009, through September 30, 2010. The estimated median income for a four-person family living in the United States for this period is $72,336. These estimates become effective for LIHEAP at any time between the date of this publication 

and October 1, 2009, or the beginning of a LIHEAP grantee’s fiscal year, whichever is later. 1Prepared by the U.S. Census Bureau, U.S. Department of Commerce (Census Bureau), from an average of data from the 2005, 2006 and 

2007 American Community Surveys (ACSs). These estimates, like those derived from any survey, are subject to two types of errors: (1) Nonsampling Error, which consists of random errors that increase the variability of the data and non-random errors that consistently direct the data 

into a specific direction; and (2) Sampling Error, which consists of the error that arises from the use of probability sampling to create the sample. 2These figures were calculated by the U.S. Department of Health and Human Services, Administration for Children and Families, Office of 

Community Services, Division of Energy Assistance (DEA) by multiplying the estimated State median income for a four-person family for each 

State by 60 percent. 3To adjust for different sizes of family, 45 CFR 96.85 calls for multiplying 60 percent of a State’s estimated median income for a four-person 

family by the following percentages: 52 percent for one person, 68 percent for two persons, 84 percent for three persons, 100 percent for four 

persons, 116 percent for five persons, and 132 percent for six persons. For each additional family member above six persons, 45 CFR 96.85 

calls for adding 3 percentage points to the percentage for a six-person family (132 percent) and multiply the new percentage by 60 percent of a 

State’s estimated median income for a four-person family. 

[FR Doc. E9–5412 Filed 3–12–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0633] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Postmarketing 

Adverse Drug Experience Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 13, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0230. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Postmarketing Adverse Drug 

Experience Reporting (OMB Control 

Number 0910–0230—Extension) 

Sections 201, 502, 505, and 701 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 321, 352, 355, and 

371) require that marketed drugs be safe 

and effective. In order to know whether 

drugs that are not safe and effective are 

on the market, FDA must be promptly 

informed of adverse experiences 

occasioned by the use of marketed 

drugs. In order to help ensure this, FDA 

issued regulations at §§ 310.305 and 

314.80 (21 CFR 310.305 and 314.80) to 

impose reporting and recordkeeping 

requirements on the drug industry that 

would enable FDA to take the action 


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Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 10925 

necessary to protect the public health 

from adverse drug experiences. 

All applicants who have received 

marketing approval of drug products are 

required to report to FDA serious, 

unexpected adverse drug experiences, 

as well as followup reports when 

needed (§ 314.80(c)(1)). This includes 

reports of all foreign or domestic 

adverse experiences as well as those 

based on information from applicable 

scientific literature and certain reports 

from postmarketing studies. Section 

314.80(c)(1)(iii) pertains to such reports 

submitted by non-applicants. Under 

§ 314.80(c)(2), applicants must provide 

periodic reports of adverse drug 

experiences. A periodic report includes, 

for the reporting interval, reports of 

serious, expected adverse drug 

experiences and all nonserious adverse 

drug experiences and an index of these 

reports, a narrative summary and 

analysis of adverse drug experiences 

and a history of actions taken because 

of adverse drug experiences. Under 

§ 314.80(i), applicants must keep 

records of all adverse drug experience 

reports known to the applicant for 10 

years. 

For marketed prescription drug 

products without approved new drug 

applications or abbreviated new drug 

applications, manufacturers, packers, 

and distributors are required to report to 

FDA serious, unexpected adverse drug 

experiences as well as followup reports 

when needed (§ 310.305(c)). Section 

310.305(c)(5) pertains to the submission 

of followup reports to reports forwarded 

by FDA. Under § 310.305(f), each 

manufacturer, packer, and distributor 

shall maintain for 10 years records of all 

adverse drug experiences required to be 

reported. 

The primary purpose of FDA’s 

adverse drug experience reporting 

system is to provide a signal for 

potentially serious safety problems with 

marketed drugs. Although premarket 

testing discloses a general safety profile 

of a new drug’s comparatively common 

adverse effects, the larger and more 

diverse patient populations exposed to 

the marketed drug provide the 

opportunity to collect information on 

rare, latent, and long-term effects. 

Signals are obtained from a variety of 

sources, including reports from patients, 

treating physicians, foreign regulatory 

agencies, and clinical investigators. 

Information derived from the adverse 

drug experience reporting system 

contributes directly to increased public 

health protection because the 

information enables FDA to make 

important changes to the product’s 

labeling (such as adding a new 

warning), decisions about risk 

evaluation and mitigation strategies or 

the need for postmarket studies or 

clinical trials, and when necessary, to 

initiate removal of a drug from the 

market. 

Respondents to this collection of 

information are manufacturers, packers, 

distributors, and applicants. 

In the Federal Register of December 

16, 2008 (73 FR 76358), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

on the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

310.305(c)(5) 1 1 1 1 1 

314.80(c)(1)(iii) 5 1 5 1 5 

314.80(c)(2) 642 17.88 11,478 60 688,680 

Total 688,686 

1The reporting burden for §§ 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) was reported under OMB control no. 0910– 

0291. The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency per 

Recordkeeping 

Total Annual 

Records Hours per Record Total Hours 

310.305(f) 25 1 25 16 400 

314.80(i) 642 623 400,000 16 6,400,000 

Total 7,088,680 

1There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually. 


sroberts on PROD1PC70 with NOTICES
10926 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 

Dated: March 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5494 Filed 3–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA–2009–N–0667] 

[FDA 225–07–8006] 

Memorandum of Understanding With 

Baylor College of Medicine, The 

University of Texas M.D. Anderson 

Cancer Center, Rice University, 

University of Houston, The University 

of Texas Health Science Center at 

Houston, Texas A&M Health Science 

Center, The University of Texas 

Medical Branch at Galveston, and The 

Methodist Hospital Research Institute 

for the FDA-ANH Nanotechnology 

Initiative 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) with The 

Alliance for NanoHealth (ANH), a 

collaboration among: Baylor College of 

Medicine, The University of Texas M.D. 

Anderson Cancer Center, Rice 

University, University of Houston, The 

University of Texas Health Science 

Center at Houston, Texas A&M Health 

Science Center, The University of Texas 

Medical Branch at Galveston, and The 

Methodist Hospital Research Institute. 

This MOU identifies the terms of 

collaboration between FDA and ANH in 

the area of nanotechnology. Specifically, 

this MOU establishes the FDA-ANH 

Nanotechnology Initiative (FANTI), a 

public-private partnership dedicated to 

the identification of scientific and 

translational gaps in moving 

nanoengineered medical products from 

the preclinical stages of development 

through clinical stages and then to 

commercialization, all with immediate 

benefit to public health. The activities 

are aligned with the mutual interests 

and respective missions of the Parties, 

including the FDA’s Critical Path 

Initiative which seeks to modernize the 

product development and regulatory 

sciences needed to reduce uncertainties 

about product performance throughout 

the product life cycle. Thus, a key goal 

for the Parties is to improve the safety 

and efficacy of nanoengineered products 

and speed their delivery to the patients 

who need them and the consumers who 

use them. 

DATES: The agreement became effective 

February 11, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Wendy R. Sanhai, Office of the 

Commissioner (HZ–1), Food and Drug 

Administration, 5600 Fishers Lane, 

suite 6A–08, Rockville, MD 20857, 301– 

827–7867. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: March 4, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

BILLING CODE 4160–01–S 


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