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Draft Guidance for Industry on 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availability of a draft guidance for 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on the draft guidance by May 30, 2011.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draft guidance to http:// 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, 

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13630 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

MD 20993–0002 or the Office of 

Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit electronic comments on the 

revised 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Michael Jones, Office of Regulatory 

Policy, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Bldg. 51, rm. 6216, Silver 

Spring, MD 20993–0002, 301–796–3602, 

or Stephen Ripley, Center for Biologics 

Evaluation and Research, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 for 

applicants planning to request waivers 

or reductions in user fees assessed 

under sections 735 and 736 of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act). This revised draft 

guidance describes the types of waivers 

and reductions permitted under the user 

fee provisions of the FD&C Act, and the 

procedures for submitting requests for 

waivers or reductions and requests for 

reconsideration and appeal. The revised 

draft guidance also provides 

clarification on related issues such as 

user fee exemptions for orphan drugs. 

After comments are received and 

considered, FDA intends to promptly 

issue a final guidance. 

This revised 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 user fee waivers and 

reductions for drug products. 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 

Under the Paperwork Reduction Act 

of 1995 (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 that 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 for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with this draft 

guidance, FDA invites comments on the 

following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

The draft guidance describes how to 

submit requests for waivers, reductions, 

and refunds of certain user fees. It also 

includes recommendations for 

submitting information for requests for 

reconsideration of denials of waiver or 

reduction requests, and for requests for 

appeals. We estimate that the total 

annual number of waiver requests 

submitted for all of these categories will 

be 90, submitted by 75 different 

sponsors. We estimate that the average 

burden hours for preparation of a 

submission will total 16 hours. Because 

FDA may request additional information 

from the applicant during the review 

period, we have also included in this 

estimate time to prepare any additional 

information. 

The reconsideration and appeal 

requests are not addressed in the FD&C 

Act but are discussed in the draft 

guidance. We estimate that we will 

receive three requests for 

reconsideration annually, and that the 

total average burden hours for a 

reconsideration request will be 24 

hours. We estimate that we will receive 

one request annually for an appeal of a 

user fee waiver determination, and that 

the time needed to prepare an appeal 

would be approximately 12 hours. 

Reconsideration requests are sent to the 

Associate Director for Policy at the 

Center for Drug Evaluation and Research 

(CDER), and requests for appeals are 

sent to the User Fee Appeals Officer at 

FDA, with a copy to the Associate 

Director for Policy at CDER. We have 

also included in this estimate both the 

time needed to prepare the request for 

appeal and the time needed to create 

and send a copy of the request for an 

appeal to the Associate Director for 

Policy at CDER. 

The burden for filling out and 

submitting Form FDA 3397 

(Prescription Drug User Fee Coversheet) 

has not been included in the burden 

analysis, because that information 

collection is already approved by OMB 

under OMB control number 0910–0297. 

The collections of information 

associated with a new drug application 

or biologics license application have 

been approved under OMB control 

numbers 0910–0001 and 0910–0338, 

respectively. 

We have included in the burden 

estimate the preparation and submission 

of application fee waivers for small 

businesses, because small businesses 

requesting a waiver must submit 

documentation to FDA on the number of 

their employees and must include the 

information that the application is the 

first human drug application, within the 

meaning of the FD&C Act, to be 

submitted to the Agency for approval. 

Because the Small Business 

Administration (SBA) makes the size 

determinations for FDA, small 

businesses must also submit 

information to the SBA. The submission 

of information to SBA is already 

approved by OMB under OMB control 

number 3245–0101. FDA estimates the 

burden of this collection of information 

as follows: 

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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13631 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Total number 

of waiver 

requests 

annually 

Annual 

frequency per 

response 

Number of 

sponsors/ 

applicants 

Total average 

burden hours Total hours 

Federal Food, Drug, and Cosmetic Act Section 736 .......... 90 1.2 75 16 1,440 

Reconsideration Requests ................................................... 3 1 3 24 72 

Appeal Requests .................................................................. 1 1 1 12 12 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,524 

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

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

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/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://www.fda.

gov.BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

guidances/default.htm, or http:// 

www.regulations.gov. 

Dated: March 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5737 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–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

026 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 026’’ (Recognition List 

Number: 026), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit written or electronic 

comments concerning this document at 

any time. See section VII of this 

document for the effective date of the 

recognition of standards announced in 

this document. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 026’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Silver Spring, MD 20993. Send two selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 301–847–8149. Submit 

written comments concerning this 

document, or recommendations for 

additional standards for recognition, to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). Submit 

electronic comments by e-mail: 

standards@cdrh.fda.gov. This document 

may also be accessed on FDA’s Internet 

site at http://www.fda.gov/ 

MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. See section 

VI of this document for electronic access 

to the searchable database for the 

current list of FDA recognized 

consensus standards, including 

Recognition List Number: 026 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3632, Silver Spring, 

MD 20993, 301–796–6574. 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 360d). Amended 

section 514 allows FDA to recognize 

consensus standards developed by 

international and national organizations 

for use in satisfying portions of device 

premarket review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how FDA would 

implement its standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, are identified in 

Table 1 as follows: 

TABLE 1—PREVIOUS PUBLICATIONS OF

STANDARD RECOGNITION LISTS

February 25, 1998 (63 FR 9561). 

October 16, 1998 (63 FR 55617). 

July 12, 1999 (64 FR 37546). 

November 15, 2000 (65 FR 69022). 

May 7, 2001 (66 FR 23032). 

January 14, 2002 (67 FR 1774). 

October 2, 2002 (67 FR 61893). 

April 28, 2003 (68 FR 22391). 

March 8, 2004 (69 FR 10712). 

June 18, 2004 (69 FR 34176). 

October 4, 2004 (69 FR 59240). 

May 27, 2005 (70 FR 30756). 

November 8, 2005 (70 FR 67713). 

March 31, 2006 (71 FR 16313). 

June 23, 2006 (71 FR 36121). 

November 3, 2006 (71 FR 64718). 

May 21, 2007 (72 FR 28500). 

September 12, 2007 (72 FR 52142). 

December 19, 2007 (72 FR 71924). 

September 9, 2008 (73 FR 52358). 

March, 18, 2009 (74 FR 11586). 

September 8, 2009 (74 FR 46203). 

May 5, 2010 (75 FR 24711). 

June 10, 2010 (75 FR 32943). 

October 4, 2010 (75 FR 61148). 

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