81 FR 23304 - Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
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 | 23304-23305 | |
| FR Document | 2016-09152 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23304-23305] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09152] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0655] Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for notification of participation. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders--including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts-- in developing recommendations for the next AGDUFA program, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation. [[Page 23305]] DATES: Submit notification of intention to participate in continued periodic stakeholder consultation meetings regarding AGDUFA reauthorization by May 16, 2016. These stakeholder meetings are expected to commence in June/July 2016 and will continue at least once every 4 months during reauthorization negotiations with the regulated industry. See the SUPPLEMENTARY INFORMATION section for further information regarding notification of intention to participate. ADDRESSES: The stakeholder meetings will be held at the Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855. 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 In 2013 Congress passed the Animal Generic Drug User Fee Amendments of 2013 (Pub. L. 113-14; AGDUFA II). The authority for AGDUFA II expires September 30, 2018. Without new legislation to reauthorize the program, FDA will no longer be able to collect user fees for future fiscal years to fund the generic new animal drug review process. Section 742(d)(1) of the FD&C Act (21 U.S.C. 379j-22(d)(1)) requires that FDA consult with a range of stakeholders in developing recommendations for consideration for the next AGDUFA program, including representatives from patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts. To initiate this process of consultation, elsewhere in this issue of the Federal Register, we are announcing a public meeting to be held on May 16, 2016, where stakeholders and other members of the public will be given an opportunity to present their views on the reauthorization. The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. Section 742(d)(3) of the FD&C Act further requires that FDA continue meeting with these stakeholders at least once every 4 months during negotiations with the regulated industry to continue discussions of their views on the reauthorization, including suggested changes to the AGDUFA program. FDA is issuing this Federal Register notice to request that stakeholders--including veterinary, patient and consumer groups, as well as scientific and academic experts--notify FDA of their intent to participate in the periodic consultation meetings on AGDUFA reauthorization. FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions. If you wish to participate in this part of the reauthorization process, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions. Stakeholders who identify themselves through this notice will be included in all future stakeholder discussion while FDA negotiates with the regulated industry. If a stakeholder decides to participate in these meetings at a later time, they may still participate in remaining meetings by notifying FDA (see ADDRESSES). These stakeholder discussions will satisfy the requirement in section 742(d)(3) of the FD&C Act. II. Notification of Intent To Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding AGDUFA reauthorization, please submit notification by email to: [email protected] by May 16, 2016. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, telephone number, and notice of any special accommodations required due to a disability. Stakeholders will receive confirmation and additional information about the first meeting after FDA receives this notification. Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09152 Filed 4-19-16; 8:45 am] BILLING CODE 4164-01-P
![23304 Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
Silver Spring, MD 20993–0002, 301– scope of this guidance will not have to regulations 21 CFR 314.50, 314.70, and
796–7579 or Stephen Ripley, Center for submit commercial-scale CMC 314.81(b)(2) for human drugs and 21
Biologics Evaluation and Research, information on postchange products to CFR 601.2 and 601.12 for biologics. The
Food and Drug Administration, Bldg. FDA before making the proposed collection of information is approved
71, Rm. 7268, 10903 New Hampshire changes. The draft guidance is intended under the following OMB Control
Ave., Silver Spring, MD 20993–0002, to establish a framework to promote Numbers: 0910–0001 for human drugs
240–402–7911. manufacturing of quality drug products and 0910–0338 for biologics.
SUPPLEMENTARY INFORMATION: by employing the following:
• Effective use of knowledge and III. Electronic Access
I. Background understanding of the product and Persons with access to the Internet
FDA is announcing the availability of manufacturing process. may obtain the document at either
a draft guidance for industry entitled • A robust control strategy. http://www.fda.gov/Drugs/Guidance
‘‘Comparability Protocols for Human • Risk management activities over a ComplianceRegulatoryInformation/
Drugs and Biologics: Chemistry, product’s life cycle. Guidances/default.htm, http://
Manufacturing, and Controls • An effective pharmaceutical quality www.regulations.gov, or http://
Information.’’ This draft guidance is a system. www.fda.gov/BiologicsBloodVaccines/
revised version of a draft guidance that This draft guidance incorporates the GuidanceComplianceRegulatory
published in February 2003 entitled modern regulatory concepts stated in Information/default.htm.
‘‘Comparability Protocols: Chemistry, the guidance for industry entitled
‘‘PAT—A Framework for Innovative Dated: April 14, 2016.
Manufacturing, and Controls
Pharmaceutical Development, Leslie Kux,
Information.’’ A related draft guidance
entitled ‘‘Comparability Protocols— Manufacturing, and Quality Assurance,’’ Associate Commissioner for Policy.
Protein Drug Products and Biological (http://www.fda.gov/downloads/Drugs/ [FR Doc. 2016–09137 Filed 4–19–16; 8:45 am]
Products—Chemistry, Manufacturing, GuidanceComplianceRegulatory BILLING CODE 4164–01–P
and Controls Information,’’ which Information/Guidances/
published in September 2003, was UCM070305.pdf) the Pharmaceutical
withdrawn on May 6, 2015 (80 FR Current Good Manufacturing Practices DEPARTMENT OF HEALTH AND
26059). for the 21st Century Initiative (http:// HUMAN SERVICES
The revised draft guidance provides www.fda.gov/Drugs/Development
recommendations to holders of ApprovalProcess/Manufacturing/ Food and Drug Administration
applications for human drugs and QuestionsandAnswersonCurrentGood [Docket No. FDA–2011–N–0655]
biologics on implementing a chemistry, ManufacturingPracticescGMPforDrugs/
manufacturing, controls (CMC) UCM071836), the Critical Path Initiative Animal Generic Drug User Fee Act;
postapproval change(s) through the use (http://www.fda.gov/scienceresearch/ Stakeholder Consultation Meetings on
of a comparability protocol (CP). The specialtopics/criticalpathinitiative/ the Animal Generic Drug User Fee Act
revised draft guidance applies to new default.htm), and the quality by design Reauthorization; Request for
drug applications (NDAs), abbreviated principles described in the guidance for Notification of Stakeholder Intention
new drug applications (ANDAs), or industry entitled ‘‘Q8(R2) To Participate
biologics license applications (BLAs) Pharmaceutical Development’’ (http://
regulated by the Center for Drug www.fda.gov/ucm/groups/fdagov- AGENCY: Food and Drug Administration,
Evaluation and Research (CDER) or the public/@fdagov-drugs-gen/documents/ HHS.
Center for Biologics Evaluation and document/ucm073507.pdf). In ACTION: Notice; request for notification
Research (CBER) or supplements publishing this draft guidance, FDA is of participation.
following 21 CFR 314.70 or 21 CFR communicating its expectations and
support for the described approach. SUMMARY: The Food and Drug
601.12.
On February 25, 2003 (68 FR 8772), This draft guidance is being issued Administration (FDA or Agency) is
FDA announced the availability of the consistent with FDA’s good guidance issuing this notice to request that public
first draft version of this guidance. The practices regulation (21 CFR 10.115). stakeholders notify FDA of their intent
public comment period closed on June The draft guidance, when finalized, will to participate in periodic consultation
25, 2003. A number of comments were represent the Agency’s current thinking meetings on reauthorization of the
received, which the Agency considered on comparability protocols for Animal Generic Drug User Fee Act
carefully as it prepared this revised draft applications regulated in CDER and (AGDUFA). The statutory authority for
guidance. CBER as described previously. It does AGDUFA expires September 30, 2018.
We revised the guidance for the not create or confer any rights for or on The Federal Food, Drug, and Cosmetic
following reasons: any person and does not operate to bind Act (the FD&C Act) requires that FDA
• To provide more flexibility FDA or the public. An alternative consult with a range of stakeholders—
regarding filing procedures for a approach may be used if such approach including patient and consumer
notification of change in a condition satisfies the requirements of the advocacy groups, veterinary
established in an approved application. applicable statutes and regulations. professionals, and scientific and
• To include current pharmaceutical academic experts—in developing
II. Paperwork Reduction Act of 1995 recommendations for the next AGDUFA
quality concepts.
• To add an appendix to address This draft guidance contains program, and hold discussions with
Lhorne on DSK5TPTVN1PROD with NOTICES
commonly asked questions. information collection provisions that these stakeholders at least once every 4
This revised draft guidance provides are subject to review by the Office of months during FDA’s negotiations with
recommendations to human drug Management and Budget (OMB) under the regulated industry. The purpose of
manufacturers on implementing CMC the Paperwork Reduction Act of 1995 this request for notification is to ensure
postapproval change(s) through the use (44 U.S.C. 3501–3520). The collection of continuity and progress in these regular
of a CP. By using an approved CP, information requested in the draft discussions by establishing consistent
manufacturers whom fall within the guidance is covered under FDA stakeholder representation.
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![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23305
DATES: Submit notification of intention including veterinary, patient and SUMMARY: The Food and Drug
to participate in continued periodic consumer groups, as well as scientific Administration (FDA or Agency) is
stakeholder consultation meetings and academic experts—notify FDA of issuing this notice to request that public
regarding AGDUFA reauthorization by their intent to participate in the periodic stakeholders notify FDA of their intent
May 16, 2016. These stakeholder consultation meetings on AGDUFA to participate in periodic consultation
meetings are expected to commence in reauthorization. FDA believes that meetings on reauthorization of the
June/July 2016 and will continue at consistent stakeholder representation at Animal Drug User Fee Act (ADUFA).
least once every 4 months during these meetings will be important to The statutory authority for ADUFA
reauthorization negotiations with the ensure progress in these discussions. If expires September 30, 2018. The
regulated industry. See the you wish to participate in this part of Federal Food, Drug, and Cosmetic Act
SUPPLEMENTARY INFORMATION section for the reauthorization process, please (the FD&C Act) requires that FDA
further information regarding designate one or more representatives consult with a range of stakeholders—
notification of intention to participate. from your organization who will including patient and consumer
ADDRESSES: The stakeholder meetings commit to attending these meetings and advocacy groups, veterinary
will be held at the Food and Drug preparing for the discussions. professionals, and scientific and
Administration, Center for Veterinary Stakeholders who identify themselves academic experts—in developing
Medicine, 7519 Standish Pl., Rockville, through this notice will be included in recommendations for the next ADUFA
MD 20855. all future stakeholder discussion while program, and hold discussions with
FOR FURTHER INFORMATION CONTACT: FDA negotiates with the regulated these stakeholders at least once every 4
Cassie Ravo, Center for Veterinary industry. If a stakeholder decides to months during FDA’s negotiations with
Medicine, Food and Drug participate in these meetings at a later the regulated industry. The purpose of
Administration, 7519 Standish Pl., time, they may still participate in this request for notification is to ensure
Rockville, MD 20855, 240–402–6866, remaining meetings by notifying FDA continuity and progress in these regular
FAX: 240–276–9744, Cassie.Ravo@ (see ADDRESSES). These stakeholder discussions by establishing consistent
fda.hhs.gov. discussions will satisfy the requirement stakeholder representation.
in section 742(d)(3) of the FD&C Act. DATES: Submit notification of intention
SUPPLEMENTARY INFORMATION:
II. Notification of Intent To Participate to participate in continued periodic
I. Introduction in Periodic Stakeholder Consultation stakeholder consultation meetings
In 2013 Congress passed the Animal Meetings regarding ADUFA reauthorization by
Generic Drug User Fee Amendments of May 16, 2016. These stakeholder
If you intend to participate in meetings are expected to commence in
2013 (Pub. L. 113–14; AGDUFA II). The continued periodic stakeholder
authority for AGDUFA II expires September/October 2016 and will
consultation meetings regarding continue at least once every 4 months
September 30, 2018. Without new AGDUFA reauthorization, please submit
legislation to reauthorize the program, during reauthorization negotiations with
notification by email to: cvmagdufa@ the regulated industry. See the
FDA will no longer be able to collect fda.hhs.gov by May 16, 2016. Your SUPPLEMENTARY INFORMATION section for
user fees for future fiscal years to fund email should contain complete contact
the generic new animal drug review further information regarding
information for each attendee, including notification of intention to participate.
process. Section 742(d)(1) of the FD&C name, title, affiliation, address, email
Act (21 U.S.C. 379j–22(d)(1)) requires ADDRESSES: The stakeholder meetings
address, telephone number, and notice will be held at the Food and Drug
that FDA consult with a range of of any special accommodations required
stakeholders in developing Administration, Center for Veterinary
due to a disability. Stakeholders will Medicine, 7519 Standish Pl., Rockville,
recommendations for consideration for receive confirmation and additional
the next AGDUFA program, including MD 20855.
information about the first meeting after
representatives from patient and FOR FURTHER INFORMATION CONTACT:
FDA receives this notification.
consumer advocacy groups, veterinary Cassie Ravo, Center for Veterinary
professionals, and scientific and Dated: April 12, 2016. Medicine, Food and Drug
academic experts. To initiate this Leslie Kux, Administration,7519 Standish Pl.,
process of consultation, elsewhere in Associate Commissioner for Policy. Rockville, MD 20855, 240–402–6866,
this issue of the Federal Register, we are [FR Doc. 2016–09152 Filed 4–19–16; 8:45 am] FAX: 240–276–9744, Cassie.Ravo@
announcing a public meeting to be held BILLING CODE 4164–01–P fda.hhs.gov.
on May 16, 2016, where stakeholders SUPPLEMENTARY INFORMATION:
and other members of the public will be
given an opportunity to present their DEPARTMENT OF HEALTH AND I. Introduction
views on the reauthorization. The HUMAN SERVICES In 2013 Congress passed the Animal
meeting and written comments Drug User Fee Amendments of 2013
submitted to the docket will provide Food and Drug Administration (Pub. L. 113–14; ADUFA III). The
critical input as the Agency prepares for [Docket No. FDA–2011–N–0656] authority for ADUFA III expires
reauthorization discussions. Section September 30, 2018. Without new
742(d)(3) of the FD&C Act further Animal Drug User Fee Act; Stakeholder legislation to reauthorize the program,
requires that FDA continue meeting Consultation Meetings on the Animal FDA will no longer be able to collect
with these stakeholders at least once Drug User Fee Act Reauthorization; user fees for future fiscal years to fund
Lhorne on DSK5TPTVN1PROD with NOTICES
every 4 months during negotiations with Request for Notification of Stakeholder the animal drug review process. Section
the regulated industry to continue Intention To Participate 740A(d)(1) of the FD&C Act (21 U.S.C.
discussions of their views on the AGENCY: Food and Drug Administration, 379j–13(d)(1)) requires that FDA consult
reauthorization, including suggested HHS. with a range of stakeholders in
changes to the AGDUFA program. developing recommendations for
ACTION: Notice; request for notification
FDA is issuing this Federal Register consideration for the next ADUFA
of participation.
notice to request that stakeholders— program, including representatives from
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Document Created: 2016-04-20 01:51:22
Document Modified: 2016-04-20 01:51:22
| 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; request for notification of participation. | |
| Dates | Submit notification of intention to participate in continued periodic stakeholder consultation meetings regarding AGDUFA reauthorization by May 16, 2016. These stakeholder meetings are expected to commence in June/July 2016 and will continue at least once every 4 months during reauthorization negotiations with the regulated industry. See the SUPPLEMENTARY INFORMATION section for further information regarding notification of intention to participate. | |
| 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 23304 |
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