81 FR 23313 - Animal Drug User Fee Act; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 76 (April 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23313-23315 | |
| FR Document | 2016-09148 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23313-23315] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09148] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA). FDA invites public comment on the ADUFA program and suggestions regarding the features FDA should propose for the next ADUFA program. DATES: The meeting will be held on May 16, 2016, from 9 a.m. to 12 p.m. In order to be taken into consideration before the public meeting, submit either electronic or written comments to the docket by May 4, 2016. To permit the widest possible opportunity to obtain comments on all aspects of the public meeting, the docket will remain open for comment throughout the reauthorization of ADUFA, until December 1, 2017. In addition to being publicly viewable at http://www.regulations.gov, comments received by June 16, 2016, suggesting changes to the program, will also be published on http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The meeting will be held at the Food and Drug Administration, 7519 Standish Pl., 3rd floor, Rm. A, Rockville, MD 20855. 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-2011-N-0656 for the ``Animal Drug User Fee Act; Public Meeting.'' 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 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 [[Page 23314]] 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. FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6866, FAX: 240-276-9744, [email protected]. SUPPLEMENTARY INFORMATION: I. Introduction The authority for ADUFA expires September 30, 2018. Without new legislation, FDA will no longer have the authority to collect user fees to fund the new animal drug review process. Prior to beginning negotiations with the regulated industry on ADUFA reauthorization, section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-13 (d)(2)) requires FDA to: (1) Publish a notice in the Federal Register requesting public input on the reauthorization; (2) hold a public meeting at which the public may present its views on the reauthorization including specific suggestions for changes to the goals referred in section 740A(a) of FD&C Act; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's Web site. FDA is holding a public meeting to gather information on what FDA should consider including in the reauthorization of ADUFA. FDA is interested in responses from the public on the following two general questions and welcomes other pertinent information that stakeholders would like to share: 1. What is your assessment of the overall performance of the ADUFA program thus far? 2. What aspects of ADUFA should be retained, changed, or discontinued to further strengthen and improve the program? The following information is provided to help potential meeting participants better understand the history and evolution of ADUFA and its current status. II. Background The Animal Drug User Fee Act enacted in 2003 (Pub. L 108-130; hereinafter referred to as ``ADUFA I'') authorized FDA to collect user fees that were dedicated to expediting the review of animal drug applications in accordance with certain performance goals. The implementation of ADUFA I provided a significant funding increase for new animal drug application review process, and enabled FDA to increase the number of staff dedicated to the new animal drug application review process by 30 percent from 2003 through 2008. Under ADUFA I, the industry agreed to pay user fees that are available to FDA, in addition to appropriated funds, to spend on the new animal drug application review process. Moreover, FDA's authority to collect user fees is contingent on a certain level of spending from appropriated funds, as adjusted for inflation. As part of ADUFA I, FDA established review performance goals that have been phased in over a 5-year period. These performance goals set from FY 2004 to FY 2008 were intended to achieve progressive, yearly improvements in the time for review of new animal drug applications. By the 5th and final year of ADUFA ending on September 30, 2008, FDA agreed to review and act on 90 percent of the following submission types within the specified timeframes: New animal drug applications (NADAs) and reactivations of such applications within 180 days after submission date. Nonmanufacturing supplemental NADAs (that is supplemental NADAs for which safety or effectiveness data are required) and reactivations of such supplemental applications within 180 days after submission date. Manufacturing supplemental NADAs and reactivations of such supplemental applications within 120 days after submission date. Investigational new animal drug (INAD) study submissions within 180 days after submission date. INAD submissions consisting of protocols, that FDA and the sponsor consider to be an essential part of making the decision to approve or not approve a NADA or supplemental NADA, without substantial data, within 60 days after submission date. Administrative NADAs submitted after all scientific decisions have been made in the INAD process (that is, prior to submission of the animal drug application) within 60 days after submission date. In 2008, before ADUFA I expired, Congress passed the Animal Drug User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to as ``ADUFA II'') which included an extension of ADUFA for an additional 5 years (FY 2009 to FY 2013). ADUFA II performance goals were established based on ADUFA I FY 2008 review timeframes. In addition, FDA agreed to the following program enhancements to reduce review cycles and improve communications during reviews: Incorporating an ``end-review amendment'' process to amend pending submissions to achieve a complete review decision sooner and reduce the number of review cycles. Developing an electronic submission tool that allows industry to submit drug applications electronically. Participating with industry in public workshops on mutually agreed upon topics. Improving communications by enhancing the timeliness and predictability of foreign pre-approval inspections. In 2013, before ADUFA II expired, Congress passed the Animal Drug User Fee Amendments of 2013 (Pub. L. 113-14; hereinafter referred to as ``ADUFA III'') which included an extension of ADUFA for an additional 5 years (FY 2014 to FY 2018). ADUFA III is maintaining the ADUFA II performance goals regarding work queue procedures, timely meetings with industry, preapproval foreign inspections, and review of NADAs (including administrative NADAs), supplemental NADAs, INAD protocol submissions, and INAD study submissions. In addition, FDA agreed to the following program enhancements to further improve the review process: Discontinuing the end-review amendment procedures and replacing them with a shorter review time process for sponsors providing certain NADA and INAD submissions through the eSubmitter electronic submission tool. Implementing a new sentinel submission type and decreasing review time for certain labeling supplements. Decreasing the review time for microbial food safety hazard characterization submissions. Developing guidance for a two-phased Chemistry, Manufacturing, and Controls technical section submission and review process under the INAD file. [[Page 23315]] Permitting certain prior approval manufacturing supplements to be resubmitted as ``Supplement--Changes Being Effected in 30 days.'' Permitting comparability protocols to be submitted as protocols without substantial data in an INAD file. Developing a process where supporting information for pre- submission conferences and INAD protocols without data submissions can be submitted early. Exploring the feasibility of pursuing statutory revisions that may modify the current requirements that the use of multiple new animal drugs in the same medicated feed be subject to an approved application. Exploring the feasibility of pursuing statutory revisions that may expand the use of conditional approvals to other appropriate categories of new animal drug applications. FDA has published a number of reports that provide useful background on ADUFA I, ADUFA II, and ADUFA III. ADUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports and plans can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm. III. Meeting Information A. Meeting Format In general, the meeting format will include presentations by FDA followed by an open public comment period. Registered speakers for the open public comments will be grouped and scheduled in advance of the meeting based on their affiliation (scientific and academic experts/ veterinary professionals, representatives of consumer advocacy groups, and the regulated industry) and timing of registration. FDA presentations are planned from 9 a.m. until 10 a.m. The open public comment portion of the meeting for registered and scheduled speakers is planned to begin at 10 a.m. An opportunity for additional open public comments from meeting attendees will commence following the registered presentations, if time permits. FDA policy issues are beyond the scope of these reauthorization discussions. Accordingly, the presentations should focus on process enhancements and funding issues, not on policy issues. B. Meeting Questions Please consider the following questions for this meeting: 1. What is your assessment of the overall performance of the ADUFA III program thus far? 2. What aspects of ADUFA should be retained, changed, or discontinued to further strengthen and improve the program? C. Registration If you wish to attend and/or present at the meeting, please register by email to [email protected] by May 4, 2016. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email, and phone number. Also, please self-identify as a member of one of the following stakeholder categories: Scientific or academic experts; veterinary professionals; patients and consumer advocacy groups; or the regulated industry and whether you are requesting a scheduled presentation. Registration is free and available on a first-come, first-served basis. Early registration is recommended since seating is limited. FDA may limit the number of participants from each organization based on space constraints. Registrants will receive confirmation once their registrations are accepted. Onsite registration on the day of the public meeting will be based on space availability. FDA will try to accommodate all persons who wish to make a presentation. The time allotted for presentations may depend on the number of persons who wish to speak. If you need special accommodations due to a disability, please contact Cassie Ravo (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. D. Transcripts Please be advised that as soon as the transcript is available, it will be accessible at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be made available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at www.fda.gov. Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09148 Filed 4-19-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23313
C. Registration DEPARTMENT OF HEALTH AND confidential business information, such
HUMAN SERVICES as a manufacturing process. Please note
If you wish to attend and/or present that if you include your name, contact
at the meeting, please register by email Food and Drug Administration information, or other information that
to cvmagdufa@fda.hhs.gov by May 4, identifies you in the body of your
[Docket No. FDA–2011–N–0656]
2016. Your email should contain comments, that information will be
complete contact information for each Animal Drug User Fee Act; Public posted on http://www.regulations.gov.
attendee, including name, title, Meeting; Request for Comments • If you want to submit a comment
affiliation, address, email, and with confidential information that you
telephone number. Also, please self- AGENCY: Food and Drug Administration, do not wish to be made available to the
identify as a member of one of the HHS. public, submit the comment as a
following stakeholder categories: ACTION: Notice of public meeting; written/paper submission and in the
Scientific or academic experts; request for comments. manner detailed (see ‘‘Written/Paper
veterinary professionals; patients and Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
consumer advocacy groups; or the Written/Paper Submissions
Administration (FDA) is announcing a
regulated industry and whether you are Submit written/paper submissions as
public meeting on the Animal Drug User
requesting a scheduled presentation. Fee Act (ADUFA). FDA invites public follows:
Registration is free and available on a comment on the ADUFA program and • Mail/Hand delivery/Courier (for
first-come, first-served basis. Early suggestions regarding the features FDA written/paper submissions): Division of
registration is recommended since should propose for the next ADUFA Dockets Management (HFA–305), Food
seating is limited. FDA may limit the program. and Drug Administration, 5630 Fishers
number of participants from each Lane, Rm. 1061, Rockville, MD 20852.
organization based on space constraints. DATES: The meeting will be held on May • For written/paper comments
16, 2016, from 9 a.m. to 12 p.m. In order submitted to the Division of Dockets
Registrants will receive confirmation
to be taken into consideration before the Management, FDA will post your
once their registrations are accepted.
public meeting, submit either electronic comment, as well as any attachments,
Onsite registration on the day of the
or written comments to the docket by except for information submitted,
public meeting will be based on space May 4, 2016. To permit the widest
availability. FDA will try to marked and identified, as confidential,
possible opportunity to obtain if submitted as detailed in
accommodate all persons who wish to comments on all aspects of the public ‘‘Instructions.’’
make a presentation. The time allotted meeting, the docket will remain open Instructions: All submissions received
for presentations may depend on the for comment throughout the must include the Docket No. FDA–
number of persons who wish to speak. reauthorization of ADUFA, until 2011–N–0656 for the ‘‘Animal Drug
If you need special accommodations December 1, 2017. In addition to being User Fee Act; Public Meeting.’’ Received
due to a disability, please contact Cassie publicly viewable at http:// comments will be placed in the docket
Ravo (see FOR FURTHER INFORMATION www.regulations.gov, comments and, except for those submitted as
CONTACT) at least 7 days before the received by June 16, 2016, suggesting ‘‘Confidential Submissions,’’ publicly
meeting. changes to the program, will also be viewable at http://www.regulations.gov
published on http://www.fda.gov/ or at the Division of Dockets
D. Transcripts ForIndustry/UserFees/ Management between 9 a.m. and 4 p.m.,
AnimalDrugUserFeeActADUFA/ Monday through Friday.
Please be advised that as soon as the ucm042891.htm. See the • Confidential Submissions—To
transcript is available, it will be SUPPLEMENTARY INFORMATION section for submit a comment with confidential
accessible at http://www.fda.gov/ registration date and information. information that you do not wish to be
ForIndustry/UserFees/AnimalGeneric made publicly available, submit your
ADDRESSES: The meeting will be held at
DrugUserFeeActAGDUFA/ comments only as a written/paper
the Food and Drug Administration, 7519
ucm270232.htm. It may be viewed at the Standish Pl., 3rd floor, Rm. A, submission. You should submit two
Division of Dockets Management (see Rockville, MD 20855. copies total. One copy will include the
ADDRESSES). A transcript will also be You may submit comments as information you claim to be confidential
made available in either hard copy or on follows: with a heading or cover note that states
CD–ROM, after submission of a ‘‘THIS DOCUMENT CONTAINS
Freedom of Information request. The Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Freedom of Information office address is Submit electronic comments in the Agency will review this copy, including
available on the Agency’s Web site at following way: the claimed confidential information, in
http://www.fda.gov. • Federal eRulemaking Portal: http:// its consideration of comments. The
Dated: April 12, 2016. www.regulations.gov. Follow the second copy, which will have the
instructions for submitting comments. claimed confidential information
Leslie Kux,
Comments submitted electronically, redacted/blacked out, will be available
Associate Commissioner for Policy. including attachments, to http:// for public viewing and posted on http://
[FR Doc. 2016–09150 Filed 4–19–16; 8:45 am] www.regulations.gov will be posted to www.regulations.gov. Submit both
BILLING CODE 4164–01–P the docket unchanged. Because your copies to the Division of Dockets
Lhorne on DSK5TPTVN1PROD with NOTICES
comment will be made public, you are Management. If you do not wish your
solely responsible for ensuring that your name and contact information to be
comment does not include any made publicly available, you can
confidential information that you or a provide this information on the cover
third party may not wish to be posted, sheet and not in the body of your
such as medical information, your or comments and you must identify this
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any
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![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23315
• Permitting certain prior approval 1. What is your assessment of the DEPARTMENT OF HEALTH AND
manufacturing supplements to be overall performance of the ADUFA III HUMAN SERVICES
resubmitted as ‘‘Supplement—Changes program thus far?
Being Effected in 30 days.’’ Health Resources and Services
2. What aspects of ADUFA should be
• Permitting comparability protocols retained, changed, or discontinued to
Administration
to be submitted as protocols without further strengthen and improve the
substantial data in an INAD file. National Vaccine Injury Compensation
program? Program; List of Petitions Received
• Developing a process where
supporting information for pre- C. Registration AGENCY: Health Resources and Services
submission conferences and INAD Administration, HHS.
If you wish to attend and/or present
protocols without data submissions can ACTION: Notice.
at the meeting, please register by email
be submitted early.
to cvmadufa@fda.hhs.gov by May 4, SUMMARY: The Health Resources and
• Exploring the feasibility of pursuing 2016. Your email should contain
statutory revisions that may modify the Services Administration (HRSA) is
complete contact information for each publishing this notice of petitions
current requirements that the use of
attendee, including name, title, received under the National Vaccine
multiple new animal drugs in the same
affiliation, address, email, and phone Injury Compensation Program (the
medicated feed be subject to an
number. Also, please self-identify as a Program), as required by Section
approved application.
member of one of the following 2112(b)(2) of the Public Health Service
• Exploring the feasibility of pursuing stakeholder categories: Scientific or
statutory revisions that may expand the (PHS) Act, as amended. While the
academic experts; veterinary Secretary of Health and Human Services
use of conditional approvals to other
professionals; patients and consumer is named as the respondent in all
appropriate categories of new animal
advocacy groups; or the regulated proceedings brought by the filing of
drug applications.
industry and whether you are requesting petitions for compensation under the
FDA has published a number of a scheduled presentation. Registration is Program, the United States Court of
reports that provide useful background free and available on a first-come, first- Federal Claims is charged by statute
on ADUFA I, ADUFA II, and ADUFA III.
served basis. Early registration is with responsibility for considering and
ADUFA-related Federal Register
recommended since seating is limited. acting upon the petitions.
notices, guidances, legislation,
FDA may limit the number of FOR FURTHER INFORMATION CONTACT: For
performance reports, and financial
participants from each organization information about requirements for
reports and plans can be found at:
based on space constraints. Registrants filing petitions, and the Program in
http://www.fda.gov/ForIndustry/
UserFees/ will receive confirmation once their general, contact the Clerk, United States
AnimalDrugUserFeeActADUFA/ registrations are accepted. Onsite Court of Federal Claims, 717 Madison
default.htm. registration on the day of the public Place NW., Washington, DC 20005,
meeting will be based on space (202) 357–6400. For information on
III. Meeting Information availability. FDA will try to HRSA’s role in the Program, contact the
A. Meeting Format accommodate all persons who wish to Director, National Vaccine Injury
make a presentation. The time allotted Compensation Program, 5600 Fishers
In general, the meeting format will for presentations may depend on the Lane, Room 08N146B, Rockville, MD
include presentations by FDA followed number of persons who wish to speak. 20857; (301) 443–6593, or visit our Web
by an open public comment period. site at: http://www.hrsa.gov/
If you need special accommodations
Registered speakers for the open public vaccinecompensation/index.html.
due to a disability, please contact Cassie
comments will be grouped and SUPPLEMENTARY INFORMATION: The
scheduled in advance of the meeting Ravo (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the Program provides a system of no-fault
based on their affiliation (scientific and compensation for certain individuals
academic experts/veterinary meeting.
who have been injured by specified
professionals, representatives of D. Transcripts childhood vaccines. Subtitle 2 of Title
consumer advocacy groups, and the XXI of the PHS Act, 42 U.S.C. 300aa–
regulated industry) and timing of Please be advised that as soon as the 10 et seq., provides that those seeking
registration. FDA presentations are transcript is available, it will be compensation are to file a petition with
planned from 9 a.m. until 10 a.m. The accessible at http://www.fda.gov/ the U.S. Court of Federal Claims and to
open public comment portion of the ForIndustry/UserFees/ serve a copy of the petition on the
meeting for registered and scheduled AnimalDrugUserFeeActADUFA/ Secretary of Health and Human
speakers is planned to begin at 10 a.m. ucm042891.htm. It may be viewed at the Services, who is named as the
An opportunity for additional open Division of Dockets Management (see respondent in each proceeding.
public comments from meeting ADDRESSES). A transcript will also be The Secretary has delegated this
attendees will commence following the made available in either hard copy or on responsibility under the Program to
registered presentations, if time permits. CD–ROM, after submission of a HRSA. The Court is directed by statute
FDA policy issues are beyond the Freedom of Information request. The to appoint special masters who take
scope of these reauthorization Freedom of Information office address is evidence, conduct hearings as
discussions. Accordingly, the available on the Agency’s Web site at appropriate, and make initial decisions
Lhorne on DSK5TPTVN1PROD with NOTICES
presentations should focus on process www.fda.gov. as to eligibility for, and amount of,
enhancements and funding issues, not Dated: April 12, 2016. compensation.
on policy issues. A petition may be filed with respect
Leslie Kux,
to injuries, disabilities, illnesses,
B. Meeting Questions Associate Commissioner for Policy. conditions, and deaths resulting from
Please consider the following [FR Doc. 2016–09148 Filed 4–19–16; 8:45 am] vaccines described in the Vaccine Injury
questions for this meeting: BILLING CODE 4164–01–P Table (the Table) set forth at 42 CFR
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Document Created: 2016-04-20 01:51:42
Document Modified: 2016-04-20 01:51:42
| 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 public meeting; request for comments. | |
| Dates | The meeting will be held on May 16, 2016, from 9 a.m. to 12 p.m. In order to be taken into consideration before the public meeting, submit either electronic or written comments to the docket by May 4, 2016. To permit the widest possible opportunity to obtain comments on all aspects of the public meeting, the docket will remain open for comment throughout the reauthorization of ADUFA, until December 1, 2017. In addition to being publicly viewable at http:// www.regulations.gov, comments received by June 16, 2016, suggesting changes to the program, will also be published on http://www.fda.gov/ ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Cassie Ravo, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6866, FAX: 240-276-9744, [email protected] | |
| FR Citation | 81 FR 23313 |
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