The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Draft Guidance for Industry; Availability, 43381-43383 [2017-19609]

Download as PDF Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices (Rehabilitation Act), as amended by the Workforce Innovation and Opportunity Act (WIOA, Pub. L. 113–128), and the corresponding regulations at 45 CFR part 1329, require centers for independent living (CILs) to submit annual performance reports to the Administrator of the Administration for Community Living (ACL) in order to receive continuation funding under the IL Parts B and C programs. The 704 reports are submitted annually by all Centers for Independent Living, designated State entities and Statewide Independent Living Councils receiving IL Parts B and C funds. The 704 Parts I and II reports are used by ACL to assess grantees’ compliance with title VII of the Act, with section 1329 of the Code of Federal Regulations, and with applicable provisions of the HHS regulations at 45 CFR part 75. The 704 Parts I and II reports serve as the primary basis for ACL’s monitoring activities in fulfillment of its responsibilities under sections 706 and 722 of the Act. The 704 Parts I and II reports also enable ACL to collect qualitative and quantitative data to track performance outcomes and efficiency measures of the IL programs with respect to the annual and long-term performance targets established in compliance with the GPRA Modernization Act of 2010 (GPRAMA) reporting requirements. The 704 Parts I and II reports are also used by ACL to design CIL and SILC training and technical assistance programs authorized by section 721 of the Act. Comments in Response to the 60-Day Federal Register Notice A 60-day notice was published in the Federal Register in Vol. 82, No. 35, pg. 11471 on February 23rd, 2017. A Notice of Correction was published in the Federal Register in Vol. 82, No. 42 pg. 12610 on March 6th, 2017, announcing that ACL had made changes to the submission instructions, the public comments closing date was incorrect, the public comments email box was incorrect, and the core services were misstated in the original Federal Register posting ACL received comments from 50 (Fifty) organizations that provided 221 (Two Hundred and Twenty-One) individual comments about the proposed information collection. ACL reviewed all of the comments. The majority of the comments that ACL received expressed concerns over inclusion of sexual orientation and gender identity questions in the reporting instrument and asked that those questions be removed; the separate demographics and services provided to individuals with significant disabilities, and the 43381 need for clarification on the definitions and instructions as well as revisions to the IL core services and additional services sections of the updated reporting instrument. Further deliberation is needed to ensure that we appropriately address all of the concerns. This work will inform a redesign of the proposed information collection forms prior to the expiration of the extension. Annual Burden Estimates A copy of the existing Centers for Independent Living (CILs), designated State entities (DSEs) and Statewide Independent Living Councils (SILCs) Annual Performance Reports (704 Parts I and II reports can be found on ACL’s Web site at: https://www.acl.gov/aboutacl/public-input. The 704 Report’s estimated hour burden per respondent each for the Part I (IL Part B) and Part II (IL Part C) in 2017 remains unchanged at 35 hours from 2014 because the current data collection instrument is the same as the one approved in 2014. The total estimated hour burden also remains the same because the number of respondents, 412, has not changed since the 2014 approval. The aggregate total hour burden for 412 Parts I and II 704 Report is estimated at 14,385, as follows: Report Number of DSEs and SILCs (Part B) Frequency of responses per year Average burden hours per response Total annual burden hours 704 Report, Part I ............................................................................................ 55 1 35 1,925 Report Number of IL Centers (Part C) Frequency of responses per year Average burden hours per response Total annual burden hours 704 Report, Part II ........................................................................................... 356 1 35 12,460 Estimated Total Annual Burden Hours: 14,385. Dated: September 11, 2017. Mary Lazare, Principal Deputy Administrator. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–2462] [FR Doc. 2017–19560 Filed 9–14–17; 8:45 am] BILLING CODE 4154–01–P The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Draft Guidance for Industry; Availability mstockstill on DSK30JT082PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. 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 SUMMARY: VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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: E:\FR\FM\15SEN1.SGM 15SEN1 43382 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 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’’). mstockstill on DSK30JT082PROD with NOTICES 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 VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 ‘‘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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 selfaddressed 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, dorothy.bailey@fda.hhs.gov. 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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 https://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 E:\FR\FM\15SEN1.SGM 15SEN1 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 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 https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–4792] Regulatory Considerations for Microneedling Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Regulatory Considerations for Microneedling Devices—Draft Guidance for Industry and Food and Drug Administration Staff.’’ This draft guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comment 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: mstockstill on DSK30JT082PROD with NOTICES SUMMARY: 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, VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 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–4792 for ‘‘Regulatory Considerations for Microneedling Devices—Draft Guidance for Industry and Food and Drug Administration Staff.’’ 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 43383 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Regulatory Considerations for Microneedling Devices—Draft Guidance for Industry and Food and Drug Administration Staff’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Peter Yang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1551, Silver Spring, MD 20993–0002, 301–796–6477. SUPPLEMENTARY INFORMATION: I. Background ‘‘Microneedling products’’ is a generic term that encompasses instruments with common technological features that include an array of needles, ‘‘microprotrusion’’ tips, or pins, which can be E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43381-43383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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, dorothy.bailey@fda.hhs.gov.

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 https://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 https://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
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