21752 Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices 

ESTIMATED STATE MEDIAN INCOME FOR A FOUR-PERSON FAMILY, BY STATE, FOR FEDERAL FISCAL YEAR (FFY) 2012, 

FOR USE IN THE LOW INCOME HOME ENERGY ASSISTANCE PROGRAM (LIHEAP)—Continued 

States 

Estimated State 

median income for 

four-person 

families1

60 percent of estimated State median income for 

four-person 

families 2 3

Pennsylvania ................................................................................................................................................ 78,287 46,972 

Rhode Island ................................................................................................................................................ 87,669 52,601 

South Carolina ............................................................................................................................................. 64,228 38,537 

South Dakota ............................................................................................................................................... 68,064 40,838 

Tennessee ................................................................................................................................................... 63,480 38,088 

Texas ........................................................................................................................................................... 65,508 39,305 

Utah ............................................................................................................................................................. 70,322 42,193 

Vermont ....................................................................................................................................................... 74,877 44,926 

Virginia ......................................................................................................................................................... 85,546 51,328 

Washington .................................................................................................................................................. 81,788 49,073 

West Virginia ................................................................................................................................................ 58,739 35,243 

Wisconsin ..................................................................................................................................................... 77,946 46,768 

Wyoming ...................................................................................................................................................... 75,998 45,599 

Note: FFY 2012 covers the period of October 1, 2011, through September 30, 2012. The estimated median income for four-person families living in the United States for this period is $74,985. These estimates become effective for LIHEAP at any time between the date of this publication 

and October 1, 2011, 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 three-year estimates from the 2007, 2008 and 

2009 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. 2011–8993 Filed 4–15–11; 8:45 am] 

BILLING CODE 4184–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0214] 

Guidance for Industry on How To Write 

a Request for Designation; 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 ‘‘How to Write a Request for 

Designation (RFD).’’ This guidance is 

intended to clarify the type of 

information the Office of Combination 

Products (OCP) recommends that a 

sponsor include in a Request for 

Designation (RFD). This final guidance 

supersedes the previous RFD guidance 

document issued August 2005. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Office of Combination Products, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5129, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kristina Lauritsen, Office of 

Combination Products, Food and Drug 

Administration, Bldg. 32, rm. 5132, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–8936. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘How to 

Write a Request for Designation (RFD).’’ 

This guidance addresses 21 CFR 3.7 and 

is intended to clarify the type of 

information OCP recommends that a 

sponsor include in an RFD. The goal of 

this guidance is to help a sponsor 

understand what information FDA 

needs to determine the regulatory 

identity or classification of a product as 

a drug, device, biological product, or 

combination product, and to assign the 

product to the appropriate Agency 

component for review and regulation. 

This final guidance supersedes the 

previously issued RFD guidance 

document which was published on 

FDA’s Web site on August 2005. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on how to write an 

RFD. 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. Paperwork Reduction Act of 1995 

This 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 of information in 

21 CFR part 3 have been approved 

under OMB control number 0910–0523. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices 21753 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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/ 

RegulatoryInformation/Guidances/ 

ucm122047.htm or http:// 

www.regulations.gov. 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9261 Filed 4–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0240] 

Site Tours Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Tobacco Products (CTP) is announcing 

a notice for participation in its Site 

Tours Program. This program is 

intended to give CTP staff an 

opportunity to visit facilities involved 

in the growing, processing, or 

manufacturing of tobacco or tobacco 

products. These visits are intended to 

provide CTP staff with the opportunity 

to gain a better understanding of the 

tobacco industry and its operations. The 

purpose of this notice is to alert parties 

interested in participating in the Site 

Tours Program to submit requests to 

CTP. 

DATES: Interested parties should submit 

either an electronic or written request 

for participation by June 17, 2011. The 

request should include a description of 

your facility, including as applicable, a 

list of all tobacco products processed 

and/or manufactured there. Please 

specify the physical address(es) of the 

site(s) for which you are submitting a 

request along with a proposed 1-day 

tour agenda. 

ADDRESSES: If your facility is interested 

in offering a site visit, you should 

submit a request to participate in the 

program either electronically to http:// 

www.regulations.gov or in writing to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Lucinda Miner, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 877–287–1373, 

e-mail: lucinda.miner@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Pub. L. 111–31; 123 Stat. 

1776) was signed into law, amending 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) and giving FDA 

authority to regulate tobacco product 

manufacturing, distribution, and 

marketing. This includes, among other 

things, the authority to issue regulations 

related to health warnings, tobacco 

product standards, good manufacturing 

practices, as well as tobacco product 

constituents, ingredients, and additives. 

CTP is instituting the Site Tours 

Program to provide its scientific and 

regulatory staff the opportunity to gain 

a better understanding of the tobacco 

industry and its operations, including 

tobacco product manufacturing and 

aspects of tobacco growing, processing, 

and storage that may affect the physical 

and chemical properties of tobacco. 

Although FDA generally does not 

regulate tobacco farms and tobacco 

warehouses, the Agency believes that 

gaining a better understanding of the 

operations performed at these facilities 

may be helpful. The goals of the Site 

Tours Program are to: (1) Provide CTP 

firsthand exposure to industry’s 

manufacturing processes; (2) learn about 

control measures used by tobacco 

product manufacturers to ensure 

product consistency; (3) understand the 

processing of different forms of tobacco 

and the manufacturing processes used 

for various types of tobacco products 

and their influences on product 

constituents; and (4) understand how 

growing conditions, curing, storage, and 

manufacturing processes might 

influence the levels of tobacco or 

tobacco smoke constituents. 

II. Description of Site Tours Program 

In the Site Tours Program, small 

groups of CTP staff plan to observe the 

operations of tobacco growers, tobacco 

warehouses, and manufacturing 

facilities of cigarette, roll-your-own, and 

smokeless tobacco companies. Please 

note that the Site Tours Program is not 

intended to include official FDA 

inspections of facilities to determine 

compliance with the FD&C Act; rather, 

the program is meant to educate CTP 

staff and improve their understanding of 

the tobacco industry and its operations. 

III. Site Selection 

CTP plans to select one or more of 

each of the following types of facilities: 

A large cigarette manufacturing facility, 

a small cigarette manufacturing facility, 

a smokeless tobacco manufacturing 

facility, a burley tobacco farm, a fluecured tobacco farm, a tobacco rolling 

paper facility, and a tobacco warehouse. 

All travel expenses associated with the 

site tours will be the responsibility of 

CTP. Final site selections will be based 

on the availability of CTP funds and 

resources for the relevant fiscal year, as 

well as the following factors: 

(1) Compliance status of the requesting 

facility and affiliated firm, if applicable; 

(2) whether the requesting facility is in 

arrears for user fees; (3) whether the 

requesting facility or affiliated firm, if 

applicable, has a significant request or 

marketing application or submission 

pending with FDA; and (4) whether the 

requesting facility will be engaged in 

active manufacturing or processing 

during the proposed time of the visit. 

IV. Requests for Participation 

Requests are to be identified with the 

docket number found in brackets in the 

heading of this document. Requests 

received by the Agency are available for 

public examination in the Division of 

Dockets Management (see ADDRESSES) 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9260 Filed 4–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Noncompetitive Program Extension 

Supplemental Awards 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 


erowe on DSK5CLS3C1PROD with NOTICES