82 FR 43381 - The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 178 (September 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 178 (September 15, 2017)
| Page Range | 43381-43383 | |
| FR Document | 2017-19609 |
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)] [Notices] [Pages 43381-43383] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19609] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-2462] The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: Submit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: [[Page 43382]] 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-2462 for ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' 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 Dockets Management Staff 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 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 guidance document. FOR FURTHER INFORMATION CONTACT: Dorothy Bailey, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0565, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) (Pub. L. 108-282) amended the FD&C Act to provide animal drug companies with incentives to develop new animal drugs for minor species and minor uses in major species, while still ensuring appropriate safeguards for animal and human health. One of the incentives established by the MUMS Act is the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, also referred to as ``the Index.'' The Index is available for new animal drugs intended for use in minor species; the Index is not available for drugs intended for minor use in major species (horses, cattle, pigs, turkeys, chickens, dogs, and cats). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of section 572 of the FD&C Act (21 U.S.C. 360ccc-1). We refer to the process of adding a new animal drug to the Index as ``indexing.'' Indexing represents a pathway for legally marketing unapproved new animal drugs for minor species. In the Federal Register of December 6, 2007, FDA published final regulations establishing administrative procedures and criteria for listing a new animal drug for use in a minor species in the Index (72 FR 69108). These regulations, which are codified at 21 CFR part 516, subpart C, are administered by the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) within FDA's Center for Veterinary Medicine (CVM). That office also maintains the Index, which is available to the public through FDA's Web site at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125452.htm. FDA is announcing the availability of a draft GIF #210 entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This draft guidance describes the process for adding a new animal drug to the Index. 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 current thinking of FDA on ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' 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. This guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are [[Page 43383]] 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 21 CFR 516.119 through 516.165 have been approved under OMB control number 0910-0620. IV. 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 https://www.regulations.gov. Dated: September 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-19609 Filed 9-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43381
(Rehabilitation Act), as amended by the reporting requirements. The 704 Parts I need for clarification on the definitions
Workforce Innovation and Opportunity and II reports are also used by ACL to and instructions as well as revisions to
Act (WIOA, Pub. L. 113–128), and the design CIL and SILC training and the IL core services and additional
corresponding regulations at 45 CFR technical assistance programs services sections of the updated
part 1329, require centers for authorized by section 721 of the Act. reporting instrument. Further
independent living (CILs) to submit deliberation is needed to ensure that we
Comments in Response to the 60-Day
annual performance reports to the appropriately address all of the
Federal Register Notice
Administrator of the Administration for concerns. This work will inform a
Community Living (ACL) in order to A 60-day notice was published in the redesign of the proposed information
receive continuation funding under the Federal Register in Vol. 82, No. 35, pg. collection forms prior to the expiration
IL Parts B and C programs. 11471 on February 23rd, 2017. A Notice of the extension.
The 704 reports are submitted of Correction was published in the
annually by all Centers for Independent Federal Register in Vol. 82, No. 42 pg. Annual Burden Estimates
Living, designated State entities and 12610 on March 6th, 2017, announcing A copy of the existing Centers for
Statewide Independent Living Councils that ACL had made changes to the
Independent Living (CILs), designated
receiving IL Parts B and C funds. The submission instructions, the public
State entities (DSEs) and Statewide
704 Parts I and II reports are used by comments closing date was incorrect,
Independent Living Councils (SILCs)
ACL to assess grantees’ compliance with the public comments email box was
Annual Performance Reports (704 Parts
title VII of the Act, with section 1329 of incorrect, and the core services were
I and II reports can be found on ACL’s
the Code of Federal Regulations, and misstated in the original Federal
Web site at: https://www.acl.gov/about-
with applicable provisions of the HHS Register posting ACL received
acl/public-input. The 704 Report’s
regulations at 45 CFR part 75. The 704 comments from 50 (Fifty) organizations
estimated hour burden per respondent
Parts I and II reports serve as the that provided 221 (Two Hundred and
each for the Part I (IL Part B) and Part
primary basis for ACL’s monitoring Twenty-One) individual comments
II (IL Part C) in 2017 remains unchanged
activities in fulfillment of its about the proposed information
at 35 hours from 2014 because the
responsibilities under sections 706 and collection. ACL reviewed all of the
current data collection instrument is the
722 of the Act. The 704 Parts I and II comments. The majority of the
same as the one approved in 2014.
reports also enable ACL to collect comments that ACL received expressed
qualitative and quantitative data to track concerns over inclusion of sexual The total estimated hour burden also
performance outcomes and efficiency orientation and gender identity remains the same because the number of
measures of the IL programs with questions in the reporting instrument respondents, 412, has not changed since
respect to the annual and long-term and asked that those questions be the 2014 approval.
performance targets established in removed; the separate demographics The aggregate total hour burden for
compliance with the GPRA and services provided to individuals 412 Parts I and II 704 Report is
Modernization Act of 2010 (GPRAMA) with significant disabilities, and the estimated at 14,385, as follows:
Number of Frequency of Average
DSEs and Total annual
Report responses burden hours
SILCs burden hours
per year per response
(Part B)
704 Report, Part I ............................................................................................ 55 1 35 1,925
Number of Frequency of Average Total annual
Report IL Centers responses burden hours burden hours
(Part C) per year per response
704 Report, Part II ........................................................................................... 356 1 35 12,460
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Unapproved New Animal Drugs for
Hours: 14,385. HUMAN SERVICES Minor Species.’’ This draft guidance
Dated: September 11, 2017.
describes the process for adding a new
Food and Drug Administration animal drug to the Index of Legally
Mary Lazare, Marketed Unapproved New Animal
[Docket No. FDA–2017–D–2462]
Principal Deputy Administrator. Drugs for Minor Species (the Index).
[FR Doc. 2017–19560 Filed 9–14–17; 8:45 am] The Index of Legally Marketed The Index consists of a list of legally
BILLING CODE 4154–01–P Unapproved New Animal Drugs for marketed unapproved new animal drugs
Minor Species; Draft Guidance for for minor species that meet the
Industry; Availability requirements of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
AGENCY: Food and Drug Administration,
DATES: Submit either electronic or
mstockstill on DSK30JT082PROD with NOTICES
HHS.
written comments on the draft guidance
ACTION: Notice of availability. by November 14, 2017 to ensure that the
SUMMARY: The Food and Drug Agency considers your comments on
Administration (FDA or Agency) is this draft guidance before it begins work
announcing the availability of draft on the final version of the guidance.
guidance for industry (GIF) #210 ADDRESSES: You may submit comments
entitled ‘‘The Index of Legally Marketed on any guidance at any time as follows:
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![Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43383
subject to review by the Office of including attachments, to https:// claimed confidential information
Management and Budget (OMB) under www.regulations.gov will be posted to redacted/blacked out, will be available
the Paperwork Reduction Act of 1995 the docket unchanged. Because your for public viewing and posted on
(44 U.S.C. 3501–3520). The collections comment will be made public, you are https://www.regulations.gov. Submit
of information in 21 CFR 516.119 solely responsible for ensuring that your both copies to the Dockets Management
through 516.165 have been approved comment does not include any Staff. If you do not wish your name and
under OMB control number 0910–0620. confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
IV. Electronic Access such as medical information, your or information on the cover sheet and not
Persons with access to the internet anyone else’s Social Security number, or in the body of your comments and you
may obtain the draft guidance at either confidential business information, such must identify this information as
http://www.fda.gov/AnimalVeterinary/ as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
GuidanceComplianceEnforcement/ that if you include your name, contact as ‘‘confidential’’ will not be disclosed
GuidanceforIndustry/default.htm or information, or other information that except in accordance with 21 CFR 10.20
https://www.regulations.gov. identifies you in the body of your and other applicable disclosure law. For
Dated: September 11, 2017. comments, that information will be more information about FDA’s posting
posted on https://www.regulations.gov. of comments to public dockets, see 80
Anna K. Abram,
• If you want to submit a comment FR 56469, September 18, 2015, or access
Deputy Commissioner for Policy, Planning, with confidential information that you
Legislation, and Analysis. the information at: https://www.gpo.gov/
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
[FR Doc. 2017–19609 Filed 9–14–17; 8:45 am] public, submit the comment as a 23389.pdf.
BILLING CODE 4164–01–P written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Written/Paper Submissions received, go to https://
www.regulations.gov and insert the
Submit written/paper submissions as
Food and Drug Administration docket number, found in brackets in the
follows:
heading of this document, into the
[Docket No. FDA–2017–D–4792] • Mail/Hand delivery/Courier (for
‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets
Regulatory Considerations for and/or go to the Dockets Management
Management Staff (HFA–305), Food and
Microneedling Devices; Draft Guidance Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers
for Industry and Food and Drug Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
Administration Staff; Availability • For written/paper comments You may submit comments on any
submitted to the Dockets Management guidance at any time (see 21 CFR
AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as 10.115(g)(5)). An electronic copy of the
HHS. well as any attachments, except for guidance document is available for
ACTION: Notice of availability. information submitted, marked and download from the internet. See the
SUPPLEMENTARY INFORMATION section for
identified, as confidential, if submitted
SUMMARY: The Food and Drug information on electronic access to the
as detailed in ‘‘Instructions.’’
Administration (FDA or Agency) is Instructions: All submissions received guidance. Submit written requests for a
announcing the availability of the draft must include the Docket No. FDA– single hard copy of the draft guidance
guidance entitled ‘‘Regulatory 2017–D–4792 for ‘‘Regulatory document entitled ‘‘Regulatory
Considerations for Microneedling Considerations for Microneedling Considerations for Microneedling
Devices—Draft Guidance for Industry Devices—Draft Guidance for Industry Devices—Draft Guidance for Industry
and Food and Drug Administration and Food and Drug Administration and Food and Drug Administration
Staff.’’ This draft guidance is being Staff.’’ Received comments will be Staff’’ to the Office of the Center
issued to assist industry in placed in the docket and, except for Director, Guidance and Policy
understanding when a microneedling those submitted as ‘‘Confidential Development, Center for Devices and
product is a device as defined in the Submissions,’’ publicly viewable at Radiological Health, Food and Drug
Federal Food, Drug, and Cosmetic Act https://www.regulations.gov or at the Administration, 10903 New Hampshire
(the FD&C Act). This draft guidance is Dockets Management Staff between 9 Ave., Bldg. 66, Rm. 5431, Silver Spring,
not final nor is it in effect at this time. a.m. and 4 p.m., Monday through MD 20993–0002. Send one self-
DATES: Submit either electronic or Friday. addressed adhesive label to assist that
written comments on the draft guidance • Confidential Submissions—To office in processing your request.
by November 14, 2017 to ensure that the submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
Agency considers your comment on this information that you do not wish to be Peter Yang, Center for Devices and
draft guidance before it begins work on made publicly available, submit your Radiological Health, Food and Drug
the final version of the guidance. comments only as a written/paper Administration, 10903 New Hampshire
ADDRESSES: You may submit comments submission. You should submit two Ave., Bldg. 66, Rm. 1551, Silver Spring,
on any guidance at any time as follows: copies total. One copy will include the MD 20993–0002, 301–796–6477.
information you claim to be confidential SUPPLEMENTARY INFORMATION:
mstockstill on DSK30JT082PROD with NOTICES
Electronic Submissions with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS I. Background
following way: CONFIDENTIAL INFORMATION.’’ The ‘‘Microneedling products’’ is a generic
• Federal eRulemaking Portal: Agency will review this copy, including term that encompasses instruments with
https://www.regulations.gov. Follow the the claimed confidential information, in common technological features that
instructions for submitting comments. its consideration of comments. The include an array of needles, ‘‘micro-
Comments submitted electronically, second copy, which will have the protrusion’’ tips, or pins, which can be
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Document Created: 2017-09-15 00:18:29
Document Modified: 2017-09-15 00:18:29
| 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 | Submit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Dorothy Bailey, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0565, [email protected] | |
| FR Citation | 82 FR 43381 |
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