Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability, 13629-13631 [2011-5737]

Download as PDF Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 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CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0112] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information—FermentationDerived Intermediates, Drug Substances, and Related Drug Products for Veterinary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. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry #216 entitled ‘‘Chemistry, Manufacturing, and Controls (CMC) Information—Fermentation-Derived Intermediates, Drug Substances, and Related Drug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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 30, 2011.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 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. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 13629 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 https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://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. 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, SUMMARY: E:\FR\FM\14MRN1.SGM 14MRN1 13630 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices mstockstill on DSKH9S0YB1PROD with 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 https:// 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 VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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: E:\FR\FM\14MRN1.SGM 14MRN1 13631 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 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 .......... Reconsideration Requests ................................................... Appeal Requests .................................................................. 90 3 1 1.2 1 1 75 3 1 16 24 12 1,440 72 12 Total .............................................................................. ........................ ........................ ........................ ........................ 1,524 1 There 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 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 mstockstill on DSKH9S0YB1PROD with NOTICES Food and Drug Administration, HHS. ACTION: Notice. 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 SUMMARY: VerDate Mar<15>2010 16:20 Mar 11, 2011 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. DATES: 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 https://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. ADDRESSES: Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov.BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ guidances/default.htm, or https:// www.regulations.gov. AGENCY: 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. Jkt 223001 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. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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). E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13629-13631]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5737]

-----------------------------------------------------------------------

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,

[[Page 13630]]

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 https://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:

[[Page 13631]]

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Total number
of waiver Annual Number of Total average
requests frequency per sponsors/ burden hours Total hours
annually response applicants
----------------------------------------------------------------------------------------------------------------
Federal Food, Drug, and Cosmetic 90 1.2 75 16 1,440
Act Section 736................
Reconsideration Requests........ 3 1 3 24 72
Appeal Requests................. 1 1 1 12 12
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,524
----------------------------------------------------------------------------------------------------------------
\1\ There 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov.BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/guidances/default.htm, or
https://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

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