Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability, 59705-59706 [2011-24739]

Download as PDF 59705 Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices SUD does not prominently and conspicuously bear the name of the manufacturer, the manufacturer who reprocesses the SUD for reuse may identify itself using a detachable label that is intended to be affixed to the patient record. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 No. of respondents FD&C Act Section 502(u) ................................................................................... 1. There Dated: September 22, 2011. David Dorsey, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2011–24788 Filed 9–26–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0108] Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.’’ This 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 This guidance is a revision of the draft guidance entitled ‘‘Draft Interim Guidance Document for Waivers of and Reductions in User Fees,’’ issued July 16, 1993. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES 10 Total annual responses 100 1,000 Average burden per response Total hours 0.1 100 are no capital costs or operating and maintenance costs associated with this collection of information. The requirements of section 502(u) of the FD&C Act impose a minimal burden on industry. This section of the FD&C Act only requires the manufacturer, packer, or distributor of a device to include their name and address on the labeling of a device. This information is readily available to the establishment and easily supplied. From its registration and premarket submission database, FDA estimates that there are 10 establishments that distribute approximately 1,000 reprocessed SUDs. Each response is anticipated to take 0.1 hours resulting in a total burden to industry of 100 hours. AGENCY: No. of responses per respondent VerDate Mar<15>2010 16:35 Sep 26, 2011 Jkt 223001 Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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, MD 20993–0002; or the Office of Communication, Outreach, and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one selfaddressed 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 this 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. FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., 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: DATES: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.’’ This 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) (21 U.S.C. 379g and 379h, respectively). This guidance describes the types of waivers and PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 guidance also provides clarification on related issues such as user fee exemptions for orphan drugs. In the Federal Register of March 14, 2011 (76 FR 13629), FDA announced the availability of a revised draft guidance entitled ‘‘User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.’’ The notice gave interested persons the opportunity to comment by June 13, 2011. We received no comments on the revised draft guidance; however, we have made minor editorial changes and a small clarification to the guidance document. 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 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 This guidance contains information collection provisions that 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 guidance were approved under OMB control number 0910–0639. The guidance also refers to collections of information for filling out and submitting Form FDA 3397 (Prescription Drug User Fee Coversheet), previously approved under OMB control number 0910–0297, and collections of information associated with new drug applications or biologics license applications approved under OMB control numbers 0910–0001 and 0910–0338, respectively. E:\FR\FM\27SEN1.SGM 27SEN1 59706 Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm, or at https:// www.regulations.gov. Dated: September 21, 2001. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–24739 Filed 9–26–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Healthy Communities Study: How Communities Shape Children’s Health (HCS) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National SUMMARY: Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 17, 2011, Pages 35452– 3 and allowed 60 days for public comment. Three (3) comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Healthy Communities Study: How Communities Shape Children’s Health (HCS). Type of Information Collection Request: New. Need and Use of Information Collection: The HCS will address the need for a cross-cutting national study of community programs and policies and their relationship to childhood obesity. The HCS is an observational study of communities conducted over five years that aims to (1) Determine the associations between community programs/policies and Body Mass Index (BMI), diet, and physical activity in children; and (2) identify the community, family, and child factors that modify or mediate the associations between community programs/policies and BMI, diet, and physical activity in children. A total of 279 communities and over 23,000 children and their parents will be part of the HCS over the five-year study. A HCS community is defined as a high school catchment area and the age range of children is 3–15 years upon entry into the study. The study examines quantitative and qualitative information obtained from community-based initiatives; community characteristics (e.g., school environment); measurements of children’s physical activity levels and dietary practices; and children’s and parents’ BMIs. Results from the Healthy Communities Study may influence the future development and funding of policies and programs to reduce childhood obesity. Furthermore, HCS results will be published in scientific journals and will be used for the development of future research initiatives targeting childhood obesity. Frequency of Response: Varies by participant type from once to 2.74 times. Affected Public: Families or households; businesses, other for-profit, and nonprofit. Type of Respondents: Parents, children, community key informants (who have knowledge about community programs/policies related to healthy nutrition, physical activity, and healthy weight of children), food service personnel, physical education instructors, state health department employees, and physicians or medical secretaries. The annual reporting burden is as follows: Estimated number of respondents: 247,619; Estimated Number of Responses per Respondent: 1.1; Average (Annual) Burden Hours per Response: 0.12; and Estimated Total Burden Hours Requested: 33,144. The annualized cost to respondents is estimated at $434,789. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated number of respondents * Estimated number of responses per respondent Parents/Caregivers (screening) ....................................................................... Parents/Caregivers .......................................................................................... Second Parents/Caregivers ............................................................................. Parents/Caregivers who refuse to participate ................................................. Children ............................................................................................................ Key Informants (screening) ............................................................................. Key Informants ................................................................................................. Food Service Personnel .................................................................................. Physical Education Instructors ........................................................................ State Health Department employees .............................................................. Physicians/medical secretaries ........................................................................ 169,650 20,358 10,179 2,410 20,358 4,820 3,615 964 964 50 14,251 1 1.46 1 1 1.46 1 2.74 1 1 1 1 0.17 1.14 0.12 0.17 0.78 0.08 0.85 0.42 0.25 0.30 0.17 9,614 11,295 407 137 7,728 129 2,806 135 80 5 808 Total .......................................................................................................... 247,619 ........................ ........................ 33,144 mstockstill on DSK4VPTVN1PROD with NOTICES Type of respondents Average burden hours per response Estimated total annual burden hours requested * * Estimated for first three years of the five-year study. Request for Comments: Written comments and/or suggestions from the public and affected agencies should VerDate Mar<15>2010 16:35 Sep 26, 2011 Jkt 223001 address one or more of the following points: (1) Evaluate whether the proposed collection of information is PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 necessary for the proper performance of the function of the agency, including whether the information will have E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59705-59706]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24739]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0108]


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 guidance for industry entitled ``User Fee Waivers, 
Reductions, and Refunds for Drug and Biological Products.'' This 
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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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, MD 20993-0002; or the Office of 
Communication, Outreach, and Development (HFM-40), Center for Biologics 
Evaluation and Research, 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. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on this 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.

FOR FURTHER INFORMATION CONTACT:
Michael Jones, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., 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 guidance for industry 
entitled ``User Fee Waivers, Reductions, and Refunds for Drug and 
Biological Products.'' This 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) (21 U.S.C. 379g and 379h, respectively). 
This 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 guidance also provides clarification on 
related issues such as user fee exemptions for orphan drugs.
    In the Federal Register of March 14, 2011 (76 FR 13629), FDA 
announced the availability of a revised draft guidance entitled ``User 
Fee Waivers, Reductions, and Refunds for Drug and Biological 
Products.'' The notice gave interested persons the opportunity to 
comment by June 13, 2011. We received no comments on the revised draft 
guidance; however, we have made minor editorial changes and a small 
clarification to the guidance document.
    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 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

    This guidance contains information collection provisions that 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 guidance were approved under OMB 
control number 0910-0639. The guidance also refers to collections of 
information for filling out and submitting Form FDA 3397 (Prescription 
Drug User Fee Coversheet), previously approved under OMB control number 
0910-0297, and collections of information associated with new drug 
applications or biologics license applications approved under OMB 
control numbers 0910-0001 and 0910-0338, respectively.

[[Page 59706]]

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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or at https://www.regulations.gov.

    Dated: September 21, 2001.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24739 Filed 9-26-11; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.