83 FR 10732 - Proprietary Names for New Animal Drugs; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 48 (March 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 48 (March 12, 2018)
| Page Range | 10732-10733 | |
| FR Document | 2018-04885 |
[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)] [Notices] [Pages 10732-10733] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04885] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0626] Proprietary Names for New Animal Drugs; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' This draft guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This draft guidance proposes a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how new animal drug sponsors can request that CVM evaluate a proposed proprietary name. DATES: Submit either electronic or written comments on the draft guidance by May 11, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: 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 [[Page 10733]] 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-2018-D-0626 for ``Proprietary Names for New Animal Drugs.'' 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, 7500 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: Tom Modric, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5853, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' CVM evaluates proprietary names as a part of the new animal drug approval process. Selecting a proprietary name is a critical element in the design and development of drug product labeling because end users may rely, in part, on the proprietary name to identify which product, among thousands of available products, is intended for a given animal. 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 ``Proprietary Names for New Animal Drugs.'' 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 is not a significant regulatory action 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 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 part 514 have been approved under OMB control numbers 0910-0032 and 0910-0699; 21 CFR part 511 have been approved under OMB control number 0910-0117. 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: March 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04885 Filed 3-9-18; 8:45 am] BILLING CODE 4164-01-P
![10732 Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices
‘‘current,’’ the transitional pass-through that allows Medicare contractors to DEPARTMENT OF HEALTH AND
payment began on the first date the ensure that the provider/supplier is not HUMAN SERVICES
hospital OPPS was implemented (before sanctioned from the Medicare and/or
enactment of Benefits Improvement and Medicaid program(s), or debarred, Food and Drug Administration
Protections Act (BIPA) (Pub. L. 106– suspended or excluded from any other [Docket No. FDA–2018–D–0626]
554), on December 21, 2000). Federal agency or program. Form
Transitional pass-through payments are Number: CMS–855I (OMB control Proprietary Names for New Animal
also required for certain ‘‘new’’ drugs, number: 0938—NEW); Frequency: On Drugs; Draft Guidance for Industry;
devices and biological agents that were Occasion; Affected Public: State, Local, Availability
not being paid for as a hospital or Tribal Governments, Private Sector
outpatient department (OPD) service as AGENCY: Food and Drug Administration,
(not-for-profit institutions); Number of HHS.
of December 31, 1996, and whose cost Respondents: 513,872; Total Annual
is ‘‘not insignificant’’ in relation to the ACTION: Notice of availability.
Responses: 1,370,078; Total Annual
outpatient perspective payment system SUMMARY: The Food and Drug
Hours: 1,000,167. (For policy questions
(OPPS) payment for the procedures or Administration (FDA or Agency) is
services associated with the new drug, regarding this collection contact
Kimberly McPhillips at 410–786–5374). announcing the availability of a draft
device, or biological. Under the statute, guidance for industry #240 entitled
transitional pass-through payments can 5. Type of Information Collection ‘‘Proprietary Names for New Animal
be made for at least 2 years but not more Request: Revision of a currently Drugs.’’ This draft guidance provides
than 3 years. We have qualified approved collection; Title of recommendations to help new animal
thousands for transitional pass-through Information Collection: Outcome and drug sponsors develop proprietary
payments through our application Assessment Information Set (OASIS) names for new animal drugs that do not
process. However, to keep pace with OASIS–C2/ICD–10; Use: This request is contribute to medication errors,
emerging new technologies and make for OMB approval to modify the negatively impact safe use of the drug,
them accessible to Medicare Outcome and Assessment Information or misbrand the drug. This draft
beneficiaries in a timely manner as the Set (OASIS) that home health agencies guidance proposes a framework for
law intended, it is necessary that we (HHAs) are required to collect in order evaluating proposed proprietary names
continue to collect appropriate to participate in the Medicare program. before submitting them for review by
information from interested parties such The current version of the OASIS, the Center for Veterinary Medicine
as hospitals and pharmaceutical OASIS–C2 (0938–1279) data item set (CVM or we). It also explains how new
companies that bring to our attention was approved by the Office of animal drug sponsors can request that
specific new drugs, biologicals and CVM evaluate a proposed proprietary
Management and Budget (OMB) on
radiopharmaceuticals to be evaluated name.
December 9, 2016 and implemented on
for transitional pass-through status.
January 1, 2017. We are seeking OMB DATES: Submit either electronic or
Form Number: CMS–10008 (OMB
approval for the proposed revised written comments on the draft guidance
control number: 0938–0802); Frequency: by May 11, 2018 to ensure that the
Yearly; Affected Public: Private sector OASIS item set, referred to hereafter as
OASIS–D, scheduled for Agency considers your comment on this
(Business or other for-profit draft guidance before it begins work on
institutions); Number of Respondents: implementation on January 1, 2019. The
OASIS D is being modified to: Include the final version of the guidance.
30; Total Annual Responses: 30; Total
changes pursuant to the Improving ADDRESSES: You may submit comments
Annual Hours: 480. (For policy
questions regarding this collection Medicare Post-Acute Care on any guidance at any time as follows:
contact Raymond Bulls at 410–786– Transformation Act of 2014 (the Electronic Submissions
7267). IMPACT Act); accommodate data
Submit electronic comments in the
4. Type of Information Collection element removals to reduce burden; and following way:
Request: New collection (Request for improve formatting throughout the • Federal eRulemaking Portal:
new OMB control number); Title of document. Form Number: CMS–10545 https://www.regulations.gov. Follow the
Information Collection: Medicare (OMB control number: 0938–1279); instructions for submitting comments.
Enrollment Application for Physician Frequency: Occasionally; Affected Comments submitted electronically,
and Non-Physician Practitioners; Use: Public: Private Sector (Business or other including attachments, to https://
The application is used by Medicare for-profit and Not-for-profit www.regulations.gov will be posted to
contractors to collect data to ensure that institutions); Number of Respondents: the docket unchanged. Because your
the applicant has the necessary 12,149; Total Annual Responses: comment will be made public, you are
credentials to provide the health care 18,161,942; Total Annual Hours: solely responsible for ensuring that your
services for which they intend to bill 9,943,141. (For policy questions comment does not include any
Medicare, including information that regarding this collection contact Joan confidential information that you or a
allows the Medicare contractor to Proctor at 410–786–0949.) third party may not wish to be posted,
correctly price, process and pay the such as medical information, your or
applicant’s claims. This application Dated: March 7, 2018.
anyone else’s Social Security number, or
collects information to ensure that only William N. Parham, III, confidential business information, such
legitimate physicians, non-physician Director, Paperwork Reduction Staff, Office as a manufacturing process. Please note
amozie on DSK30RV082PROD with NOTICES
practitioners, and other eligible of Strategic Operations and Regulatory that if you include your name, contact
professionals are enrolled in the Affairs. information, or other information that
Medicare program. It is meant to be the [FR Doc. 2018–04893 Filed 3–9–18; 8:45 am] identifies you in the body of your
first line defense to protect our BILLING CODE 4120–01–P comments, that information will be
beneficiaries from illegitimate providers posted on https://www.regulations.gov.
and to protect the Medicare Trust Fund • If you want to submit a comment
against fraud. It also gathers information with confidential information that you
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![Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices 10733
do not wish to be made available to the Docket: For access to the docket to subject to review by the Office of
public, submit the comment as a read background documents or the Management and Budget (OMB) under
written/paper submission and in the electronic and written/paper comments the Paperwork Reduction Act of 1995
manner detailed (see ‘‘Written/Paper received, go to https:// (44 U.S.C. 3501–3520). The collections
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the of information in 21 CFR part 514 have
docket number, found in brackets in the been approved under OMB control
Written/Paper Submissions heading of this document, into the numbers 0910–0032 and 0910–0699; 21
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts CFR part 511 have been approved under
follows: and/or go to the Dockets Management OMB control number 0910–0117.
• Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061,
IV. Electronic Access
written/paper submissions): Dockets Rockville, MD 20852.
Management Staff (HFA–305), Food and You may submit comments on any Persons with access to the internet
Drug Administration, 5630 Fishers guidance at any time (see 21 CFR may obtain the draft guidance at either
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). http://www.fda.gov/AnimalVeterinary/
• For written/paper comments Submit written requests for single GuidanceComplianceEnforcement/
submitted to the Dockets Management copies of the guidance to the Policy and GuidanceforIndustry/default.htm or
Staff, FDA will post your comment, as Regulations Staff (HFV–6), Center for https://www.regulations.gov.
well as any attachments, except for Veterinary Medicine, Food and Drug Dated: March 6, 2018.
information submitted, marked and Administration, 7500 Standish Pl., Leslie Kux,
identified, as confidential, if submitted Rockville, MD 20855. Send one self-
Associate Commissioner for Policy.
as detailed in ‘‘Instructions.’’ addressed adhesive label to assist that
[FR Doc. 2018–04885 Filed 3–9–18; 8:45 am]
office in processing your requests. See
Instructions: All submissions received BILLING CODE 4164–01–P
the SUPPLEMENTARY INFORMATION section
must include the Docket No. FDA–
for electronic access to the draft
2018–D–0626 for ‘‘Proprietary Names
guidance document.
for New Animal Drugs.’’ Received DEPARTMENT OF HEALTH AND
FOR FURTHER INFORMATION CONTACT: Tom
comments will be placed in the docket HUMAN SERVICES
and, except for those submitted as Modric, Center for Veterinary Medicine
‘‘Confidential Submissions,’’ publicly (HFV–216), Food and Drug Health Resources and Service
viewable at https://www.regulations.gov Administration, 7519 Standish Pl., Administration
or at the Dockets Management Staff Rockville, MD 20855, 240–402–5853,
between 9 a.m. and 4 p.m., Monday tomislav.modric@fda.hhs.gov. Bright Futures Periodicity Schedule
through Friday. SUPPLEMENTARY INFORMATION: Updates
• Confidential Submissions—To I. Background AGENCY: Health Resources and Service
submit a comment with confidential FDA is announcing the availability of Administration (HRSA), Department of
information that you do not wish to be a draft guidance for industry #240 Health and Human Services (HHS).
made publicly available, submit your entitled ‘‘Proprietary Names for New ACTION: Notice.
comments only as a written/paper Animal Drugs.’’ CVM evaluates
submission. You should submit two SUMMARY: Effective December 21, 2017,
proprietary names as a part of the new HRSA updated the HRSA-supported
copies total. One copy will include the animal drug approval process. Selecting
information you claim to be confidential guidelines for infants, children, and
a proprietary name is a critical element adolescents for purposes of health
with a heading or cover note that states in the design and development of drug
‘‘THIS DOCUMENT CONTAINS insurance coverage for preventive
product labeling because end users may services, as set out in the Bright Futures
CONFIDENTIAL INFORMATION.’’ The rely, in part, on the proprietary name to
Agency will review this copy, including Periodicity Schedule. This notice serves
identify which product, among as an announcement of the decision to
the claimed confidential information, in thousands of available products, is
its consideration of comments. The update these guidelines as listed below.
intended for a given animal. Please see https://mchb.hrsa.gov/
second copy, which will have the
claimed confidential information II. Significance of Guidance maternal-child-health-topics/child-
redacted/blacked out, will be available This level 1 draft guidance is being health/bright-futures.html for additional
for public viewing and posted on issued consistent with FDA’s good information.
https://www.regulations.gov. Submit guidance practices regulation (21 CFR FOR FURTHER INFORMATION CONTACT:
both copies to the Dockets Management 10.115). The draft guidance, when Bethany D. Miller, LCSW–C, M.Ed.,
Staff. If you do not wish your name and finalized, will represent the current HRSA/Maternal and Child Health
contact information to be made publicly thinking of FDA on ‘‘Proprietary Names Bureau by calling (301) 495–5156 or
available, you can provide this for New Animal Drugs.’’ It does not emailing BMiller@hrsa.gov.
information on the cover sheet and not establish any rights for any person and SUPPLEMENTARY INFORMATION: The Bright
in the body of your comments and you is not binding on FDA or the public. Futures program has been funded by
must identify this information as You can use an alternative approach if HRSA since 1990. A primary focus of
‘‘confidential.’’ Any information marked it satisfies the requirements of the this program is for the funding recipient
as ‘‘confidential’’ will not be disclosed applicable statutes and regulations. This to maintain and update the Bright
except in accordance with 21 CFR 10.20 is not a significant regulatory action Futures Guidelines for Health
amozie on DSK30RV082PROD with NOTICES
and other applicable disclosure law. For subject to Executive Order 12866. Supervision of Infants, Children and
more information about FDA’s posting Adolescents, a set of materials and tools
of comments to public dockets, see 80 III. Paperwork Reduction Act of 1995 that provide theory-based and evidence-
FR 56469, September 18, 2015, or access This draft guidance refers to driven guidance for all preventive care
the information at: https://www.gpo.gov/ previously approved collections of screenings and well-child visits. One
fdsys/pkg/FR-2015-09-18/pdf/2015- information found in FDA regulations. component of these tools is the Bright
23389.pdf. These collections of information are Futures Periodicity Schedule, a chart
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Document Created: 2018-11-01 08:51:24
Document Modified: 2018-11-01 08:51:24
| 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 May 11, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Tom Modric, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5853, [email protected] | |
| FR Citation | 83 FR 10732 |
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