13626 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency of 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

801.150(a)(2) ..................................................................... 57 1 57 0 .50 29 

801.410(e) and (f) .............................................................. 30 924,100 27,723,000 0 .0008 22,178 

801.421(d) .......................................................................... 10,000 160 1,600,000 0 .25 400,000 

Total ............................................................................ ........................ ........................ ........................ .......................... 422,207 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The medical device labeling 

regulations also refer to previously 

approved collections of information 

found in FDA regulations. The 

collections of information under 

§ 800.12(d) and 801.437(i) have been 

approved under OMB control number 

0910–0183; the collections of 

information under § 800.12(e) have been 

approved under OMB control number 

0910–0231; and the collections of 

information under § 801.435(g) have 

been approved under OMB control 

number 0910–0073. 

Further, FDA concludes that labeling 

statements under §§ 801.63, 

801.405(b)(2) and (b)(3), 801.420(c)(2) 

and (c)(3), 801.430(c) and (e)(1), 

801.433, 801.437(d) through (g), and 

809.30(d)(2), (d)(3), and (e) do not 

constitute a ‘‘collection of information’’ 

under the PRA. Rather, these labeling 

statements are ‘‘public disclosure’’ of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of ‘‘disclosure to the public’’ 

(5 CFR 1320.3(c)(2)). 

Reporting 

These estimates are based on FDA’s 

registration and listing database for 

medical device establishments and 

FDA’s knowledge of and experience 

with device labeling. 

Recordkeeping 

These estimates are based on FDA’s 

registration and listing database for 

medical device establishments, Agency 

communications with industry, and 

FDA’s knowledge of and experience 

with device labeling. 

The medical device labeling 

regulations also refer to previously 

approved collections of information. 

The collections of information under 

§§ 800.12(d) and 801.437(i) have been 

approved under OMB control number 

0910–0183; and the collections of 

information under § 800.12(e) have been 

approved under OMB control number 

0910–0231. 

The information collection 

requirements under §§ 801.63, 

801.405(b)(2) and (b)(3), 801.420(c)(2) 

and (c)(3), 801.430(c) and (e)(1), 

801.433, 801.437(d) through (g), and 

809.30(d)(2), (d)(3), (e) are not 

considered information collection 

because the public information is 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public (5 

CFR 1320.3(c)(2)). 

Dated: March 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5739 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0129] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Comparing 

Nutrition Knowledge, Attitude, and 

Behavior Among English-Dominant 

Hispanics, Spanish-Dominant 

Hispanics, and Other Consumers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a study entitled ‘‘Comparing Nutrition 

Knowledge, Attitude, and Behavior 

Among English-Dominant Hispanics, 

Spanish-dominant Hispanics, and Other 

Consumers.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 13, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13627 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Comparing Nutrition Knowledge, 

Attitude, and Behavior Among EnglishDominant Hispanics, SpanishDominant Hispanics, and Other 

Consumers—(OMB Control Number 

0910–NEW) 

I. Background 

Recent estimates suggest that 

Hispanics (defined as those who 

identify themselves as of Hispanic or 

Latino origin) are the largest and fastest 

growing minority group in the nation; 

the proportion of the U.S. population 

that was Hispanic was 14 percent in 

2005 and is projected to increase to 29 

percent in 2050 (Ref. 1). 

Data from the Centers for Disease 

Control and Prevention (CDC) indicate 

that, in 2005 and 2006, 34.3 percent and 

32.7 percent of the U.S. adult 

population are obese and overweight, 

respectively (Ref. 1). According to CDC, 

Hispanics had 21 percent higher obesity 

prevalence than Whites in 2008 (Ref. 2). 

CDC data also indicate variations in 

prevalence of obesity among adults of 

different race-gender groups; for 

example, during 2006 through 2008, 

non-Hispanic Blacks had the greatest 

prevalence of obesity (35.7 percent), 

followed by Hispanics (28.7 percent), 

and non-Hispanic Whites (23.7 percent); 

non-Hispanic Black women had the 

greatest prevalence (39.2 percent), 

followed by non-Hispanic Black men 

(31.6 percent), Hispanic women (29.4 

percent), Hispanic men (27.8 percent), 

non-Hispanic White men (25.4 percent), 

and non-Hispanic White women (21.8 

percent) (Ref. 2). 

While some Hispanics living in the 

United States use the English language 

exclusively or more often than Spanish 

(English-dominant Hispanics), other 

U.S. Hispanics predominantly use the 

Spanish language in their daily lives 

(Spanish-dominant Hispanics) (Ref. 4). 

Since most U.S. food labels are in 

English, Spanish-dominant Hispanics’ 

understanding and use of food labels 

may differ from that of Englishdominant Hispanics and of nonHispanics who use English exclusively. 

In addition, both English-dominant 

Hispanics and Spanish-dominant 

Hispanics may have different 

awareness, perceptions, and behaviors 

than English-speaking non-Hispanics on 

issues of health, nutrition, and food 

consumption (Refs. 5 through 9). 

Existing research suggests that, in 

addition to language and other 

demographic differences, acculturation 

is an important factor associated with 

individual differences in dietary and 

public health related perceptions, 

attitudes, and behaviors among 

Hispanics. Acculturation is defined as 

the change in behavior and values by 

immigrants when they come in contact 

with a new group, nation, or culture 

(Ref. 10). Immigrants may possess 

different degrees of acculturation 

depending on the time of migration and 

other factors, such as the dominant 

culture of the neighborhoods where they 

live and work and type of education 

received (Refs. 11 and 12). Hence, 

variation in the degree of acculturation 

can lead to differences in lifestyle and 

behaviors, including behaviors related 

to dietary choices and to use and 

understanding of nutrition information 

on food labels, because of English 

proficiency and degree of assimilation 

into the values, lifestyles, and diets 

prevalent in this country. The existing 

research has shown the influence of 

acculturation on Hispanics’ perceptions, 

attitudes, and behaviors relating to 

public health factors including dietary 

practices, nutrition, the health practices 

of pregnant women, obesity, coronary 

heart disease, Type 2 diabetes, alcohol 

consumption, and smoking behavior (for 

example, Refs. 11 and 13 through 22). 

FDA needs an understanding of how 

different population groups perceive 

and behave in terms of food label 

understanding and use, nutrition, and 

health to inform possible measures that 

the Agency may take to help consumers 

make informed dietary choices. FDA is 

aware of no consumer research on a 

nationwide level of the impact of 

language and acculturation on 

Hispanics’ dietary choices and label use. 

This study is intended to provide 

answers to research questions such as 

whether and how much Spanishdominant Hispanics, English-dominant 

Hispanics, and English-speaking nonHispanics differ in their knowledge, 

attitude, and behavior toward food label 

use, nutrition, and health among three 

population groups and the role that 

demographic and other factors may play 

in any differences. 

The proposed study will use a Webbased survey to collect information from 

2,400 adult members in online 

consumer panels maintained by a 

contractor. The study plans to randomly 

select 800 members into each of three 

groups: Spanish-dominant Hispanics, 

English-dominant Hispanics, and 

English-speaking non-Hispanics. Either 

an English or a Spanish questionnaire 

will be used, as appropriate. The study 

plans to include topics such as: (1) 

Nutrition and health; (2) use and 

understanding of food labels and 

labeling information; (3) degree of 

capacity to understand and use health 

information; and (4) levels of 

acculturation among Hispanic 

respondents as measured by a Hispanic 

acculturation scale that is widely used 

in social science research (Ref. 23). To 

help understand the data, the study will 

also collect information on participants’ 

background, including, but not limited 

to, health status and demographic 

characteristics, such as age, gender, 

education, and income. 

The study is part of the Agency’s 

continuing effort to enable consumers to 

make informed dietary choices and 

construct healthful diets. The results of 

the study will not be used to develop 

population estimates. The results of the 

study will be used for informing 

possible measures that the Agency may 

take to help consumers make informed 

dietary choices. 

To help design and refine the 

questionnaire, we plan to conduct 

cognitive interviews by screening 72 

adult panelists in order to obtain 9 

participants in the interviews. Each 

screening is expected to take 5 minutes 

(0.083 hour) and each cognitive 

interview is expected to take 0.5 hour. 

The total for cognitive interview 

activities is 11 hours (6 hours + 5 

hours). Subsequently, we plan to 

conduct two waves of pretests of the 

questionnaire before it is administered 

in the study. We expect that 960 

invitations, each taking 2 minutes (0.033 

hour), will need to be sent to adult 

members of the online consumer panels 

to have 180 of them complete a 15- 

minute (0.25 hour) pretest. The total for 

the pretest activities is 77 hours (32 

hours + 45 hours). For the survey, we 

estimate that 19,200 invitations, each 

taking 2 minutes (0.033 hour) to 

complete, will need to be sent to adult 

members of the online consumer panels 

to have 2400 of them complete a 15- 

minute (0.25 hour) questionnaire. The 

total for the survey activities is 1,234 

hours (634 hours + 600 hours). Thus, 

the total estimated burden is 1,322 

hours. FDA’s burden estimate is based 

on prior experience with research that is 

similar to this proposed study. 

FDA estimates the burden of this 

collection of information as follows: 

mstockstill on DSKH9S0YB1PROD with NOTICES

13628 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Cognitive interview screener ................................................ 72 1 72 0.083 6 

Cognitive interview ............................................................... 9 1 9 0.5 5 

Pretest invitation .................................................................. 960 1 960 0.033 32 

Pretest .................................................................................. 180 1 180 0.25 45 

Survey invitation ................................................................... 19,200 1 19,200 0.033 634 

Survey .................................................................................. 2,400 1 2,400 0.25 600 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,322 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

II. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday. (FDA has verified the 

Web site addresses, but is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. CDC, ‘‘Prevalence of Overweight, 

Obesity, and Extreme Obesity Among 

Adults: United States, Trends 1976–80 

Through 2005–2006,’’ available at http:// 

www.cdc.gov/nchs/data/hestat/

overweight/overweight_adult.pdf, 

December 2008. 

2. CDC, ‘‘Differences in Prevalence of 

Obesity Among Black, White, and 

Hispanic Adults—United States, 2006– 

2008, ‘‘Morbidity and Mortality Weekly 

Report, 58(27): 740–744, available at 

http://www.cdc.gov/mmwr/preview/

mmwrhtml/mm5827a2.htm, July 17, 

2009. 

3. Passel, J.S. and C. D’Vera, ‘‘U.S. 

Population Projections: 2005–2050,’’ 

Pew Research Center, Washington, DC, 

available at http://pewhispanic.org/ 

files/reports/85.pdf, February 11, 2008. 

4. CDC, ‘‘Health Disparities 

Experienced by Hispanics—United 

States,’’ Morbidity and Mortality Weekly 

Report, 53(40): 935–7, available at 

http://www.cdc.gov/mmwr/preview/

mmwrhtml/mm5340a1.htm, October 15, 

2004. 

5. National Heart, Lung and Blood 

Institute, ‘‘Epidemiologic Research in 

Hispanic Populations: Opportunities, 

Barriers and Solutions,’’ available at 

http://www.nhlbi.nih.gov/meetings/

workshops/hispanic.htm, December 3, 

2003. 

6. Lopez, M.H. and P. Taylor, ‘‘Latinos 

and the 2010 Census: The Foreign Born 

Are Most Positive,’’ Pew Research 

Center, Washington, DC, available at 

http://pewhispanic.org/files/reports/

121.pdf, April 10, 2010. 

7. Information Resources, INC., 

‘‘Times & Trends: Hispanic 

Consumers—Capturing CPG Market 

Potential,’’ available at http:// 

www.symphonyiri.com/portals/0/

articlePdfs/TT_April_2008_Hispanic_

Consumers.pdf, April 2008. 

8. Yang, S., M.G. Leff, D. McTague, et 

al., ‘‘Multistate Surveillance for FoodHandling, Preparation, and 

Consumption Behaviors Associated 

With Foodborne Diseases: 1995 and 

1996 Behavioral Risk Factor 

Surveillance Systems Food-Safety 

Questions,’’ Morbidity and Mortality 

Weekly Report, 47(SS–4): 33–54, 

available at http://www.cdc.gov/mmwr/

preview/mmwrhtml/00054714.htm, 

September 11, 1998. 

9. Lin, C.-T. J. and S.T. Yen, 

‘‘Knowledge of Dietary Fats Among U.S. 

Consumers,’’ Journal of the American 

Dietetic Association, 110(4): 613–8, 

April 2010. 

10. Marin, G., F. Sabogal, B.V. Marin, 

et al., ‘‘Development of a Short 

Acculturation Scale for Hispanics,’’ 

Hispanic Journal of Behavioral 

Sciences, 9(2): 183–205, 1987. 

11. Satia-About, J., R.E. Patterson, 

M.L. Neuhouser, et al., ‘‘Dietary 

Acculturation: Applications to Nutrition 

Research and Dietetics,’’ Journal of the 

American Dietetic Association, 102(8): 

1105–1118, August 2002. 

12. Lin, H., O.I. Bermudez, and K.L. 

Tucker, ‘‘Dietary Patterns of Hispanic 

Elders Are Associated With 

Acculturation and Obesity,’’ Journal of 

Nutrition, 133: 3651–3657, 2003. 

13. Otero-Sabogal, R., F. Sabogal, E.J. 

Pe ́rez-Stable, et al., ‘‘Dietary Practices, 

Alcohol Consumption, and Smoking 

Behavior: Ethnic, Sex, and 

Acculturation Differences,’’ Journal of 

National Cancer Institute Monograph, 

18: 73–82, 1995. 

14. Lara, M., C. Gamboa, M.I. 

Kahramanian, et al., ‘‘Acculturation and 

Latino Health in the United States: A 

Review of the Literature and Its 

Sociopolitical Context,’’ Annual Review 

of Public Health 26: 367–397. 2005. 

15. Winkleby, M.A., S.P. Fortmann, 

and B. Rockhill, ‘‘Health-Related Risk 

Factors in a Sample of Hispanics and 

Whites Matched on Sociodemographic 

Characteristics: The Stanford Five-City 

Project.’’ American Journal of 

Epidemiology, 137(12): 1365–75, June 

15, 1993. 

16. Byrd, T.L, H. Balcazar, and R.A. 

Hummer,’’ Acculturation and BreastFeeding Intention and Practice in 

Hispanic Women on the U.S.-Mexico 

Border,’’ Ethnicity & Disease 11(1): 72– 

79, 2001. 

17. Cobas, J.A., H. Balcazar, M.B. 

Benin, et al., ‘‘Acculturation and LowBirthweight Infants Among Latino 

Women: a Reanalysis of the Hispanic 

Health and Nutrition Examination 

Survey Data With Structural Equation 

Models,’’ American Journal of Public 

Health, 86(3): 394–96, 1996. 

18. Dixon, L.B., J. Sundquist, and M. 

Winkleby, ‘‘Differences in Energy, 

Nutrient, and Food Intakes in a US 

Sample of Mexican-American Women 

and Men: Findings from the Third 

National Health and Nutrition 

Examination Survey,’’ 1988–1994, 

American Journal of Epidemiology, 

152(6): 548–57, 2000. 

19. Khan, L.K., J. Sobal, and R. 

Martorell, ‘‘Acculturation, 

Socioeconomic Status, and Obesity in 

Mexican Americans, Cuban Americans, 

and Puerto Ricans,’’ International 

Journal of Obesity, 21(2): 91–96, 1997. 

20. Markides, K.S., D.J. Lee, and L.A. 

Ray, ‘‘Acculturation and Hypertension 

in Mexican Americans. Ethnicity & 

Disease,’’ 3:70–74, 1993. 

21. Stern, M.P., C. Gonzalez, B.D. 

Mitchell, et al., ‘‘Genetic and 

Environmental Determinants of Type II 

Diabetes in Mexico City and San 

Antonio. Diabetes,’’ 41(4): 484–92, 1992. 

22. Sundquist, J., and M.A. Winkleby, 

‘‘Cardiovascular Risk Factors in Mexican 

American Adults: a Transcultural 

Analysis of National Health and 

Nutrition Examination Survey III, 1988– 

1994,’’ American Journal of Public 

Health, 89(5): 723–30, 1999. 

23. Thomson, M.D., and L. HoffmanGoetz, ‘‘Defining and Measuring 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13629 

Acculturation: A Systematic Review of 

Public Health Studies With Hispanic 

Population in the United States,’’ Social 

Science & Medicine, 69: 983–991, 2009. 

Dated: March 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5736 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0112] 

Draft Guidance for Industry on 

Chemistry, Manufacturing, and 

Controls Information—FermentationDerived Intermediates, Drug 

Substances, and Related Drug 

Products for Veterinary Medicinal Use; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry #216 entitled ‘‘Chemistry, 

Manufacturing, and Controls (CMC) 

Information—Fermentation-Derived 

Intermediates, Drug Substances, and 

Related Drug Products for Veterinary 

Medicinal Use’’. The purpose of this 

document is to provide 

recommendations on what 

documentation to submit to support the 

CMC information for fermentationderived intermediates, drug substances, 

and related drug products for veterinary 

medicinal use. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 30, 2011. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine (CVM), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft 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: 

Michael J. Popek, Center for Veterinary 

Medicine (HFV–144), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8269, email: michael.popek@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #216 

entitled ‘‘Chemistry, Manufacturing, and 

Controls (CMC) Information— 

Fermentation-Derived Intermediates, 

Drug Substances, and Related Drug 

Products for Veterinary Medicinal Use.’’ 

This draft guidance provides 

recommendations on what 

documentation to submit to support the 

CMC information for fermentationderived intermediates, drug substances, 

and related drug products for veterinary 

medicinal use. This information is filed 

to CVM in a new animal drug 

application (NADA), conditional NADA, 

investigational new animal drug file, 

abbreviated NADA, generic 

investigational new animal drug file, 

drug master file, or veterinary master 

file. 

II. Significance of Guidance 

This level 1 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 this topic. 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 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 

this draft guidance have been approved 

under OMB control number 0910–0032 

(expiration date April 30, 2011). 

IV. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: March 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5816 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0108] 

Revised Draft Guidance for Industry on 

User Fee Waivers, Reductions, and 

Refunds for Drug and Biological 

Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised draft guidance 

for industry entitled ‘‘User Fee Waivers, 

Reductions, and Refunds for Drug and 

Biological Products.’’ This revised draft 

guidance provides recommendations to 

applicants considering whether to 

request a waiver or reduction in user 

fees. This guidance is a revision of the 

draft guidance entitled ‘‘Draft Interim 

Guidance Document for Waivers of and 

Reductions in User Fees,’’ issued July 

16, 1993. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 13, 2011. 

Submit written comments on the 

proposed collection of information by 

May 13, 2011. 

ADDRESSES: Submit written requests for 

single copies of the revised 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, 

mstockstill on DSKH9S0YB1PROD with NOTICES