Animal Drug User Fees and Fee Waivers and Reductions; Draft Revised Guidance for Industry; Availability, 76360-76361 [2016-26406]

Download as PDF 76360 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices prepare and submit. The guidance also recommends that other labeling changes (e.g., the addition of adverse event data) should be minimized and provided in separate supplements, and that the revision of labeling to conform to §§ 201.56 and 201.57 may require substantial revision to the ADVERSE REACTIONS or other labeling sections. 3. Section VI.C of the guidance states that applicants are encouraged to include the following statement in promotional materials for the drug. ‘‘[DRUGNAME] reduces blood pressure, which reduces the risk of fatal based on 5 CFR 1320.3(c)(2), which states that the public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within the definition of collection of information. In the Federal Register of February 22, 2016 (81 FR 8726), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We estimate the burden of this collection of information as follows: and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.’’ The inclusion of this statement in the promotional materials for the drug would be exempt from OMB review TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Activity Total annual responses Hours per response Total hours Submission to Docket No. FDA–2008–D–0150 .................. Cardiovascular Outcome Claim Supplement Submission ... 1 1 1 1 1 1 10 20 10 20 Total .............................................................................. ........................ ........................ ........................ ........................ 30 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 27, 2016. Leslie Kux, Associate Commissioner for Policy. submit either electronic or written comments on the draft revised guidance by January 3, 2017. [FR Doc. 2016–26399 Filed 11–1–16; 8:45 am] ADDRESSES: BILLING CODE 4164–01–P as follows: Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–D–0369] Animal Drug User Fees and Fee Waivers and Reductions; Draft Revised Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #170 entitled ‘‘Animal Drug User Fees and Fee Waivers and Reductions.’’ This draft revised guidance document describes the types of fees the Food and Drug Administration (FDA or the Agency) is authorized to collect under the Animal Drug User Fee Act of 2003 (ADUFA), as amended, and how to request waivers and reductions from these fees. 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 revised guidance before it begins work on the final version of the guidance, sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:18 Nov 01, 2016 Jkt 241001 You may submit comments Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2004–D–0369 for ‘‘Animal Drug User Fees and Fee Waivers and Reductions.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The E:\FR\FM\02NON1.SGM 02NON1 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, 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 revised guidance document. FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5692, diane.heinz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: sradovich on DSK3GMQ082PROD with NOTICES I. Background FDA is announcing the availability of a draft revised GFI #170 entitled ‘‘Animal Drug User Fees and Fee Waivers and Reductions.’’ This draft revised guidance document describes the types of fees FDA is authorized to collect under ADUFA and how to request waivers and reductions from these fees. It clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business VerDate Sep<11>2014 17:18 Nov 01, 2016 Jkt 241001 waivers, and makes additional clarifying changes. II. Significance of Guidance This level 1 draft revised guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft revised guidance, when finalized, will represent the current thinking of FDA on ‘‘Animal Drug User Fees and Fee Waivers and Reductions.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft revised guidance refers to previously approved collections of information 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 referred to in the guidance entitled ‘‘Animal Drug User Fees and Fee Waivers and Reductions’’ have been approved under OMB control number 0910–0540. IV. Electronic Access Persons with access to the Internet may obtain the draft revised guidance at either https://www.fda.gov/ AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: October 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–26406 Filed 11–1–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0797] Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 76361 Fax written comments on the collection of information by December 2, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0302. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. DATES: Human Tissue Intended for Transplantation—21 CFR Part 1270 OMB Control Number 0910–0302— Extension Under section 361 of the Public Health Services Act (42 U.S.C. 264), FDA issued regulations under part 1270 (21 CFR part 1270) to prevent the transmission of human immunodeficiency virus, hepatitis B, and hepatitis C through the use of human tissue for transplantation. The regulations provide for inspection by FDA of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue. These facilities are required to meet provisions intended to ensure appropriate screening and testing of human tissue donors and to ensure that records are kept documenting that the appropriate screening and testing have been completed. Section 1270.31(a) through (d) requires written procedures to be prepared and followed for the following steps: (1) All significant steps in the infectious disease testing process under § 1270.21; (2) all significant steps for obtaining, reviewing, and assessing the relevant medical records of the donor as prescribed in § 1270.21; (3) designating and identifying quarantined tissue; and (4) for prevention of infectious disease contamination or cross-contamination by tissue during processing. Section 1270.31(a) and (b) also requires recording and justification of any deviation from the written procedures. E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76360-76361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26406]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0369]


Animal Drug User Fees and Fee Waivers and Reductions; Draft 
Revised Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft revised guidance for industry (GFI) #170 
entitled ``Animal Drug User Fees and Fee Waivers and Reductions.'' This 
draft revised guidance document describes the types of fees the Food 
and Drug Administration (FDA or the Agency) is authorized to collect 
under the Animal Drug User Fee Act of 2003 (ADUFA), as amended, and how 
to request waivers and reductions from these fees.

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 revised guidance before it begins work on the final version of 
the guidance, submit either electronic or written comments on the draft 
revised guidance by January 3, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-D-0369 for ``Animal Drug User Fees and Fee Waivers and 
Reductions.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The

[[Page 76361]]

Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft revised guidance document.

FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary 
Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5692, diane.heinz@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft revised GFI #170 
entitled ``Animal Drug User Fees and Fee Waivers and Reductions.'' This 
draft revised guidance document describes the types of fees FDA is 
authorized to collect under ADUFA and how to request waivers and 
reductions from these fees. It clarifies the criteria for Barrier to 
Innovation waivers, clarifies the procedures for Small Business 
waivers, and makes additional clarifying changes.

II. Significance of Guidance

    This level 1 draft revised guidance is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The draft 
revised guidance, when finalized, will represent the current thinking 
of FDA on ``Animal Drug User Fees and Fee Waivers and Reductions.'' It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft revised guidance refers to previously approved 
collections of information 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 referred to in 
the guidance entitled ``Animal Drug User Fees and Fee Waivers and 
Reductions'' have been approved under OMB control number 0910-0540.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft revised 
guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26406 Filed 11-1-16; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.