81 FR 76360 - Animal Drug User Fees and Fee Waivers and Reductions; Draft Revised Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 212 (November 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 212 (November 2, 2016)
| Page Range | 76360-76361 | |
| FR Document | 2016-26406 |
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)] [Notices] [Pages 76360-76361] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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, [email protected]. 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 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://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
![76360 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
prepare and submit. The guidance also and nonfatal cardiovascular events, based on 5 CFR 1320.3(c)(2), which
recommends that other labeling changes primarily strokes and myocardial states that the public disclosure of
(e.g., the addition of adverse event data) infarctions. Control of high blood information originally supplied by the
should be minimized and provided in pressure should be part of Federal government to the recipient for
separate supplements, and that the comprehensive cardiovascular risk the purpose of disclosure to the public
revision of labeling to conform to management, including, as appropriate, is not included within the definition of
§§ 201.56 and 201.57 may require lipid control, diabetes management, collection of information.
substantial revision to the ADVERSE antithrombotic therapy, smoking In the Federal Register of February
REACTIONS or other labeling sections. cessation, exercise, and limited sodium 22, 2016 (81 FR 8726), we published a
3. Section VI.C of the guidance states intake. Many patients will require more 60-day notice requesting public
that applicants are encouraged to than one drug to achieve blood pressure comment on the proposed extension of
include the following statement in goals.’’ this collection of information. No
promotional materials for the drug. The inclusion of this statement in the comments were received.
‘‘[DRUGNAME] reduces blood promotional materials for the drug We estimate the burden of this
pressure, which reduces the risk of fatal would be exempt from OMB review collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Hours
Number of responses Total
Activity annual per
respondents per hours
responses response
respondent
Submission to Docket No. FDA–2008–D–0150 .................. 1 1 1 10 10
Cardiovascular Outcome Claim Supplement Submission ... 1 1 1 20 20
Total .............................................................................. ........................ ........................ ........................ ........................ 30
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 27, 2016. submit either electronic or written Written/Paper Submissions
Leslie Kux, comments on the draft revised guidance Submit written/paper submissions as
Associate Commissioner for Policy. by January 3, 2017. follows:
[FR Doc. 2016–26399 Filed 11–1–16; 8:45 am]
ADDRESSES: You may submit comments • Mail/Hand delivery/Courier (for
BILLING CODE 4164–01–P
as follows: written/paper submissions): Division of
Dockets Management (HFA–305), Food
Electronic Submissions and Drug Administration, 5630 Fishers
DEPARTMENT OF HEALTH AND Lane, Rm. 1061, Rockville, MD 20852.
HUMAN SERVICES Submit electronic comments in the
• For written/paper comments
following way:
Food and Drug Administration submitted to the Division of Dockets
• Federal eRulemaking Portal: http:// Management, FDA will post your
[Docket No. FDA–2004–D–0369] www.regulations.gov. Follow the comment, as well as any attachments,
instructions for submitting comments. except for information submitted,
Animal Drug User Fees and Fee Comments submitted electronically, marked and identified, as confidential,
Waivers and Reductions; Draft Revised including attachments, to http:// if submitted as detailed in
Guidance for Industry; Availability www.regulations.gov will be posted to ‘‘Instructions.’’
AGENCY: Food and Drug Administration, the docket unchanged. Because your Instructions: All submissions received
HHS. comment will be made public, you are must include the Docket No. FDA–
ACTION: Notice of availability. solely responsible for ensuring that your 2004–D–0369 for ‘‘Animal Drug User
comment does not include any Fees and Fee Waivers and Reductions.’’
SUMMARY: The Food and Drug confidential information that you or a Received comments will be placed in
Administration (FDA or Agency) is third party may not wish to be posted, the docket and, except for those
announcing the availability of a draft such as medical information, your or submitted as ‘‘Confidential
revised guidance for industry (GFI) #170 anyone else’s Social Security number, or Submissions,’’ publicly viewable at
entitled ‘‘Animal Drug User Fees and confidential business information, such http://www.regulations.gov or at the
Fee Waivers and Reductions.’’ This draft Division of Dockets Management
as a manufacturing process. Please note
revised guidance document describes between 9 a.m. and 4 p.m., Monday
that if you include your name, contact
the types of fees the Food and Drug through Friday.
information, or other information that
Administration (FDA or the Agency) is
identifies you in the body of your • Confidential Submissions—To
authorized to collect under the Animal submit a comment with confidential
Drug User Fee Act of 2003 (ADUFA), as comments, that information will be
information that you do not wish to be
amended, and how to request waivers posted on http://www.regulations.gov.
made publicly available, submit your
sradovich on DSK3GMQ082PROD with NOTICES
and reductions from these fees. • If you want to submit a comment comments only as a written/paper
DATES: Although you can comment on with confidential information that you submission. You should submit two
any guidance at any time (see 21 CFR do not wish to be made available to the copies total. One copy will include the
10.115(g)(5)), to ensure that the Agency public, submit the comment as a information you claim to be confidential
considers your comment on this draft written/paper submission and in the with a heading or cover note that states
revised guidance before it begins work manner detailed (see ‘‘Written/Paper ‘‘THIS DOCUMENT CONTAINS
on the final version of the guidance, Submissions’’ and ‘‘Instructions’’). CONFIDENTIAL INFORMATION.’’ The
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![Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 76361
Agency will review this copy, including waivers, and makes additional clarifying DATES: Fax written comments on the
the claimed confidential information, in changes. collection of information by December
its consideration of comments. The 2, 2016.
II. Significance of Guidance
second copy, which will have the ADDRESSES: To ensure that comments on
claimed confidential information This level 1 draft revised guidance is the information collection are received,
redacted/blacked out, will be available being issued consistent with FDA’s good OMB recommends that written
for public viewing and posted on http:// guidance practices regulation (21 CFR comments be faxed to the Office of
www.regulations.gov. Submit both 10.115). The draft revised guidance, Information and Regulatory Affairs,
copies to the Division of Dockets when finalized, will represent the OMB, Attn: FDA Desk Officer, FAX:
Management. If you do not wish your current thinking of FDA on ‘‘Animal 202–395–7285, or emailed to oira_
name and contact information to be Drug User Fees and Fee Waivers and submission@omb.eop.gov. All
made publicly available, you can Reductions.’’ It does not establish any comments should be identified with the
provide this information on the cover rights for any person and is not binding OMB control number 0910–0302. Also
sheet and not in the body of your on FDA or the public. You can use an include the FDA docket number found
comments and you must identify this alternative approach if it satisfies the in brackets in the heading of this
information as ‘‘confidential.’’ Any requirements of the applicable statutes document.
information marked as ‘‘confidential’’ and regulations.
FOR FURTHER INFORMATION CONTACT: FDA
will not be disclosed except in III. Paperwork Reduction Act of 1995 PRA Staff, Office of Operations, Food
accordance with 21 CFR 10.20 and other and Drug Administration, Three White
applicable disclosure law. For more This draft revised guidance refers to
previously approved collections of Flint North, 10A63, 11601 Landsdown
information about FDA’s posting of St., North Bethesda, MD 20852,
comments to public dockets, see 80 FR information that are subject to review by
the Office of Management and Budget PRAStaff@fda.hhs.gov.
56469, September 18, 2015, or access SUPPLEMENTARY INFORMATION: In
the information at: http://www.fda.gov/ (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The compliance with 44 U.S.C. 3507, FDA
regulatoryinformation/dockets/ has submitted the following proposed
default.htm. collections of information referred to in
the guidance entitled ‘‘Animal Drug collection of information to OMB for
Docket: For access to the docket to review and clearance.
read background documents or the User Fees and Fee Waivers and
electronic and written/paper comments Reductions’’ have been approved under Human Tissue Intended for
received, go to http:// OMB control number 0910–0540. Transplantation—21 CFR Part 1270
www.regulations.gov and insert the IV. Electronic Access OMB Control Number 0910–0302—
docket number, found in brackets in the Persons with access to the Internet Extension
heading of this document, into the may obtain the draft revised guidance at Under section 361 of the Public
‘‘Search’’ box and follow the prompts either http://www.fda.gov/ Health Services Act (42 U.S.C. 264),
and/or go to the Division of Dockets AnimalVeterinary/ FDA issued regulations under part 1270
Management, 5630 Fishers Lane, Rm. GuidanceComplianceEnforcement/ (21 CFR part 1270) to prevent the
1061, Rockville, MD 20852. GuidanceforIndustry/default.htm or transmission of human
Submit written requests for single
http://www.regulations.gov. immunodeficiency virus, hepatitis B,
copies of the guidance to the Policy and
Dated: October 27, 2016. and hepatitis C through the use of
Regulations Staff (HFV–6), Center for
Leslie Kux, human tissue for transplantation. The
Veterinary Medicine, Food and Drug
regulations provide for inspection by
Administration, 7519 Standish Pl., Associate Commissioner for Policy.
FDA of persons and tissue
Rockville, MD 20855. Send one self- [FR Doc. 2016–26406 Filed 11–1–16; 8:45 am]
establishments engaged in the recovery,
addressed adhesive label to assist that BILLING CODE 4164–01–P screening, testing, processing, storage,
office in processing your requests. See or distribution of human tissue. These
the SUPPLEMENTARY INFORMATION section facilities are required to meet provisions
for electronic access to the draft revised DEPARTMENT OF HEALTH AND intended to ensure appropriate
guidance document. HUMAN SERVICES screening and testing of human tissue
FOR FURTHER INFORMATION CONTACT: donors and to ensure that records are
Diane Heinz, Center for Veterinary Food and Drug Administration
kept documenting that the appropriate
Medicine (HFV–6), Food and Drug [Docket No. FDA–2013–N–0797] screening and testing have been
Administration, 7519 Standish Pl., completed.
Rockville, MD 20855, 240–402–5692, Agency Information Collection Section 1270.31(a) through (d)
diane.heinz@fda.hhs.gov. Activities; Proposed Collection; requires written procedures to be
SUPPLEMENTARY INFORMATION:
Comment Request; Human Tissue prepared and followed for the following
Intended for Transplantation steps: (1) All significant steps in the
I. Background infectious disease testing process under
AGENCY: Food and Drug Administration,
FDA is announcing the availability of HHS. § 1270.21; (2) all significant steps for
a draft revised GFI #170 entitled ACTION: Notice. obtaining, reviewing, and assessing the
‘‘Animal Drug User Fees and Fee relevant medical records of the donor as
Waivers and Reductions.’’ This draft SUMMARY: The Food and Drug prescribed in § 1270.21; (3) designating
sradovich on DSK3GMQ082PROD with NOTICES
revised guidance document describes Administration (FDA or we) is and identifying quarantined tissue; and
the types of fees FDA is authorized to announcing that a proposed collection (4) for prevention of infectious disease
collect under ADUFA and how to of information has been submitted to the contamination or cross-contamination
request waivers and reductions from Office of Management and Budget by tissue during processing. Section
these fees. It clarifies the criteria for (OMB) for review and clearance under 1270.31(a) and (b) also requires
Barrier to Innovation waivers, clarifies the Paperwork Reduction Act of 1995 recording and justification of any
the procedures for Small Business (the PRA). deviation from the written procedures.
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Document Created: 2016-11-02 01:40:52
Document Modified: 2016-11-02 01:40:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| Contact | Diane Heinz, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5692, [email protected] | |
| FR Citation | 81 FR 76360 |
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