82 FR 49377 - Animal Generic Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 205 (October 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 205 (October 25, 2017)
| Page Range | 49377-49379 | |
| FR Document | 2017-23173 |
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)] [Notices] [Pages 49377-49379] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23173] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0655] Animal Generic Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the availability of the Animal Generic Drug User Fee Act (AGDUFA) reauthorization draft recommendations and extending the comment period to allow interested persons 30 days to submit comments on these draft recommendations. DATES: FDA is extending the comment period on the AGDUFA reauthorization and draft recommendations. Submit either electronic or written comments on the draft recommendations by November 24, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 24, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-2011-N-0655 for ``Animal Generic Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment Period'' Received comments, those filed in a timely manner (see ADDRESSES), 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 [[Page 49378]] 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. FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-6866, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of the proposed recommendations for the reauthorization of AGDUFA, which authorizes FDA to collect user fees and use them for the process of reviewing generic new animal drug applications and associated submissions. The authority for AGDUFA expires September 30, 2018. Without new legislation, FDA will no longer have the authority to collect user fees to fund the generic new animal drug review process for future fiscal years. Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j- 22(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholders, and before transmitting the Agency's final recommendation to Congress for the reauthorized program (AGDUFA III), we do the following: (1) Present the recommendations to the relevant Congressional committees, (2) publish such recommendations in the Federal Register, (3) provide for a period of 30 days for the public to provide written comments on such recommendations, (4) hold a meeting at which the public may present its views on such recommendations, and (5) consider such public views and comments and revise such recommendations as necessary. In the Federal Register of October 5, 2017 (82 FR 46506), we announced a public meeting to be held on November 2, 2017. In that notice we stated that we intended to publish in the Federal Register the full text of the proposed AGDUFA III Performance Goals and Procedures Letter and a summary of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm, before the public meeting and would provide for a period of 30 days for the public to provide written comments. This notice announces the availability of these draft recommendations and extends the comment period to November 24, 2017 to provide for a period of 30 days for the public to comment on these draft recommendations. After the public meeting and closing of the comment period, we will revise the draft recommendations as necessary. In addition, the Agency will present the draft recommendations to the Congressional committees. II. Proposed AGDUFA III Recommendations A. Enhancing the Process for Premarket Review We are proposing the following changes to the performance commitments previously established to further enhance the process for review of generic new animal drug applications. Beginning October 1, 2018, all applications and submissions under section 512(b) of the FD&C Act (21 U.S.C. 360b(b)) must be submitted to the Agency electronically using the eSubmitter tool. The Agency will review and act on 90 percent of original abbreviated new animal drug applications (ANADAs) within 240 days (180- day review plus 60-day administrative review) after the submission date. An application is incomplete if it would require additional data or information to enable the Agency to complete a comprehensive review of the application and reach a decision on the issue(s) presented in the application. If the Agency determines that the deficiencies are not substantial, the Agency will review and act on 90 percent of reactivated applications within 120 days (60-day review plus 60-day administrative review) after the reactivated ANADA submission date. This shorter review time for reactivated ANADAs for which the deficiencies are determined not to be substantial is not intended to prevent the use of minor amendments during Agency review of an application. If the Agency determines that the deficiencies are substantial or new substantial information is provided, the Agency will review and act on 90 percent of reactivated applications within 240 days (180-day review plus 60-day administrative review) after the reactivated ANADA submission date. The Agency will review and act on 90 percent of administrative ANADAs (ANADAs submitted after all scientific decisions have been made in the generic investigational new animal drug (JINAD) process, i.e., prior to the submission of the ANADA) within 60 days after the submission date. Paragraph IV certification applications (section 512(n)(1)(H)(iv) of the FD&C Act) submitted as administrative ANADAs will be excluded from the administrative ANADA cohort. The Agency will review and act on 90 percent of Prior Approval manufacturing supplemental ANADAs within 180 days after the submission date. A Prior Approval manufacturing supplemental ANADA includes: One or more major manufacturing changes according to Sec. 514.8(b)(2)(ii) (21 CFR 514.8(b)(2)(ii)) and in accordance with Guidance for Industry #83, ``Chemistry, Manufacturing, and Controls Changes to an Approved NADA or ANADA''; and changes submitted as ``Supplement-Changes Being Effected in 30 Days'' that require prior approval according to Sec. 514.8(b)(3)(v)(A). If a Prior Approval supplement does not clearly identify any major manufacturing changes, the Prior Approval supplement will be designated by the Agency as a ``Supplement--Changes Being Effected'' with a 270-day review goal (see ``Supplement--Changes Being Effected Manufacturing Supplemental ANADAs and Reactivations'' below). A submission is incomplete if it requires additional data or information to enable the Agency to complete a comprehensive review of the submission and reach a decision on the issue(s) presented in the submission. If the Agency determines that the deficiencies are not substantial for manufacturing supplements requiring prior approval, the Agency will allow the manufacturing supplements to be resubmitted as ``Supplement-Changes Being Effected in 30 Days'' as described [[Page 49379]] in Sec. 514.8(b)(3) and the drug made with the change can be distributed 30 days after the resubmission according to Sec. 514.8(b)(3)(iv). The Agency will review and act on 90 percent of these reactivated manufacturing supplements within 270 days after the resubmission date of a complete submission. If the Agency determines that the deficiencies remain substantial or new substantial information is provided, prior approval is required according to Sec. 514.8(b)(3)(v)(A). The Agency will review and act on 90 percent of these reactivated manufacturing supplements within 180 days after the resubmission date of a complete submission. The Agency will review and act on 90 percent of ``Supplement- Changes Being Effected'' manufacturing supplemental ANADAs and reactivations submitted according to Sec. 514.8(b)(3)(vi) and in accordance with Guidance for Industry #83, ``Chemistry, Manufacturing, and Controls Changes to an Approved NADA or ANADA,'' including manufacturing changes not requiring prior approval according to Sec. 514.8(b)(3)(iv), within 270 days after the submission date. The Agency will review and act on 90 percent of JINAD study submissions within 180 days after the submission date. A submission is incomplete if it would require additional data or information to enable the Agency to complete a comprehensive review of the study submission and reach a decision on the issue(s) presented in the submission. If the Agency determines that the deficiencies are not substantial, the Agency will review and act on 90 percent of resubmitted JINAD study submissions within 60 days after the receipt date of a complete study submission. This shorter review time for resubmitted JINAD study submissions is not intended to prevent the use of minor amendments during Agency review of a study submission. If the Agency determines that the deficiencies are substantial or new substantial information is provided, the Agency will review and act on 90 percent of resubmitted JINAD study submissions within 180 days after the receipt date of a complete study submission. The Agency will review and act on 90 percent of JINAD submissions consisting of protocols without substantial data, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an ANADA or supplemental ANADA, within 75 days after the submission date. The Agency will allow comparability protocols as described in Sec. 514.8(b)(2)(v) to be submitted as protocols without substantial data in a JINAD file. The Agency will review and act on 90 percent of JINAD submissions consisting of protocols without substantial data within 75 days after the submission date of the protocol. For potentially more complex comparability protocols, for example sterile process validation protocols, the sponsor should discuss and have Agency concurrence regarding the appropriate filing strategy. The Agency will continue to allow two-phased Chemistry, Manufacturing, and Controls technical section submissions under the JINAD process. The Agency and regulated industry are committed to improving the review and business processes that will facilitate the timely scheduling and conducting of pre-approval inspections (PAIs). To improve the timeliness and predictability of foreign PAIs, sponsors may voluntarily submit: (1) At the beginning of the calendar year, a list of foreign manufacturing facilities that are specified in an abbreviated application, supplemental abbreviated application, or generic investigational file and may be subject to foreign PAIs for the following fiscal year; and (2) a notification 30 days prior to submitting an abbreviated application, a supplemental abbreviated application, or generic investigational file that informs the Agency that the application includes a foreign manufacturing facility. Should any changes to the annual list occur after its submission to the Agency, the sponsor may provide the updated information to the Agency. The Agency will keep a record of the number of foreign PAIs conducted for abbreviated applications, along with the average time for completing the PAIs, and include this information in its annual performance report. The time for completing the PAI is understood to mean the time from the inspection scheduling request through notification to the Center for Veterinary Medicine (CVM) of inspectional findings. The Agency and regulated industry agree that the use of both formal meetings (e.g., pre-submission conferences, workshops) and informal communication by both parties is critical to ensure high submission quality such that the above performance goals can be achieved. B. Inflation Adjuster and Workload Adjuster The Agency and regulated industry agree to change the current fixed 4 percent inflation adjuster to a variable inflation adjuster calculated using payroll cost and benefits and the Consumer Price Index less food and energy. The workload adjustment will continue to be calculated per CVM Program Policy and Procedures Manual 1243.3022, except that, for purposes of calculating the workload adjustment, it is agreed to reset the base years to fiscal year (FY) 2014 through FY 2018. There will be no workload adjustment for FY 2019. Workload adjustments are one-time adjustments and are calculated annually. C. Offset Provision and Excess Collections The proposal adds financial flexibility by eliminating the final year offset of the over collections provision and making any excess collections available to enhance the review process in real time. In addition, the proposal provides authority for the Secretary of Health and Human Services when setting fees to reduce a calculated workload adjustment up to the amount of excess collections in the second preceding fiscal year. The first fiscal year this provision could be applied while setting fees is fiscal year 2021. D. Impact of AGDUFA III Changes on User Fee Revenue The FY 2019 baseline for AGDUFA III is $18,336,340. For each year from FY 2020 through FY 2023, the annual statutory revenue amounts established in section 741(b) of the FD&C Act (21 U.S.C. 379j-21(b)) will be further adjusted according to the new statutory provision for the inflation adjuster and may be further adjusted by the workload adjuster, if applicable. The planned total 5-year revenue for AGDUFA I was $27,100,000. The planned total 5-year revenue for AGDUFA II was $38,100,000, which also included one-time information technology funding in the amount of $850,000 for FY 2014. It is estimated that the planned total 5-year revenue for AGDUFA III will be $95,000,000. The fee revenue distribution in AGDUFA III will remain the same as AGDUFA II: 25 percent in application fees; 37.5 percent in product fees; and 37.5 percent in sponsor fees. Dated: October 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-23173 Filed 10-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49377
statutes and regulations. This guidance 2. ‘‘Suggested Format for Developing and Comments submitted electronically,
is not subject to Executive Order 12866. Responding to Deficiencies in including attachments, to https://
Accordance with the Least Burdensome www.regulations.gov will be posted to
III. Electronic Access Provisions of FDAMA,’’ dated November the docket unchanged. Because your
Persons interested in obtaining a copy 2, 2000, available at: https://
www.fda.gov/downloads/Medical
comment will be made public, you are
of the guidance may do so by solely responsible for ensuring that your
Devices/DeviceRegulationandGuidance/
downloading an electronic copy from GuidanceDocuments/ucm073680.pdf. comment does not include any
the internet. A search capability for all confidential information that you or a
Center for Devices and Radiological Dated: October 20, 2017.
third party may not wish to be posted,
Health guidance documents is available Leslie Kux, such as medical information, your or
at https://www.fda.gov/MedicalDevices/ Associate Commissioner for Policy. anyone else’s Social Security number, or
DeviceRegulationandGuidance/ [FR Doc. 2017–23197 Filed 10–24–17; 8:45 am] confidential business information, such
GuidanceDocuments/default.htm. BILLING CODE 4164–01–P as a manufacturing process. Please note
Guidance documents are also available that if you include your name, contact
at https://www.fda.gov/BiologicsBlood information, or other information that
Vaccines/GuidanceCompliance DEPARTMENT OF HEALTH AND identifies you in the body of your
RegulatoryInformation/default.htm or HUMAN SERVICES comments, that information will be
https://www.regulations.gov. Persons posted on https://www.regulations.gov.
unable to download an electronic copy Food and Drug Administration • If you want to submit a comment
of ‘‘Deciding When to Submit a 510(k) [Docket No. FDA–2011–N–0655] with confidential information that you
for a Change to an Existing Device’’ may do not wish to be made available to the
send an email request to CDRH- Animal Generic Drug User Fee Act; public, submit the comment as a
Guidance@fda.hhs.gov to receive an Recommendations; Request for written/paper submission and in the
electronic copy of the document. Please Comments; Extension of Comment manner detailed (see ‘‘Written/Paper
use the document number 1500054 to Period Submissions’’ and ‘‘Instructions’’).
identify the guidance you are Written/Paper Submissions
AGENCY: Food and Drug Administration,
requesting.
HHS. Submit written/paper submissions as
IV. Paperwork Reduction Act of 1995 ACTION: Notice of availability; request follows:
This guidance refers to previously for comments; extension of comment • Mail/Hand delivery/Courier (for
approved collections of information period. written/paper submissions): Dockets
found in FDA regulations. These Management Staff (HFA–305), Food and
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
collections of information are subject to
Administration (FDA or the Agency) is Lane, Rm. 1061, Rockville, MD 20852.
review by the Office of Management and
Budget (OMB) under the Paperwork
announcing the availability of the • For written/paper comments
Animal Generic Drug User Fee Act submitted to the Dockets Management
Reduction Act of 1995 (44 U.S.C. 3501–
(AGDUFA) reauthorization draft Staff, FDA will post your comment, as
3520). The collections of information in
recommendations and extending the well as any attachments, except for
21 CFR part 820 are approved under
comment period to allow interested information submitted, marked and
OMB control number 0910–0073; the
persons 30 days to submit comments on identified, as confidential, if submitted
collections of information in 21 CFR
these draft recommendations. as detailed in ‘‘Instructions.’’
part 807, subpart E are approved under
DATES: FDA is extending the comment Instructions: All submissions received
OMB control number 0910–0120; the
collections of information in 21 CFR period on the AGDUFA reauthorization must include the Docket No. FDA–
part 803 have been approved under and draft recommendations. Submit 2011–N–0655 for ‘‘Animal Generic Drug
OMB control number 0910–0437; and either electronic or written comments User Fee Act; Recommendations;
the collections of information in 21 CFR on the draft recommendations by Request for Comments; Extension of
parts 801 and 809 are approved under November 24, 2017. Comment Period’’ Received comments,
OMB control number 0910–0485. ADDRESSES: You may submit comments those filed in a timely manner (see
as follows. Please note that late, ADDRESSES), will be placed in the docket
V. References untimely filed comments will not be and, except for those submitted as
The following references are on considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly
display in the Dockets Management be submitted on or before November 24, viewable at https://www.regulations.gov
Staff (see ADDRESSES) and are available 2017. The https://www.regulations.gov or at the Dockets Management Staff
for viewing by interested persons electronic filing system will accept between 9 a.m. and 4 p.m., Monday
between 9 a.m. and 4 p.m., Monday comments until midnight Eastern Time through Friday.
through Friday; they are also available at the end of November 24, 2017. • Confidential Submissions—To
electronically at https:// Comments received by mail/hand submit a comment with confidential
www.regulations.gov. FDA has verified delivery/courier (for written/paper information that you do not wish to be
the Web site addresses, as of the date submissions) will be considered timely made publicly available, submit your
this document publishes in the Federal if they are postmarked or the delivery comments only as a written/paper
Register, but Web sites are subject to service acceptance receipt is on or submission. You should submit two
copies total. One copy will include the
sradovich on DSK3GMQ082PROD with NOTICES
change over time. before that date.
information you claim to be confidential
1. ‘‘The Least Burdensome Provisions of the Electronic Submissions with a heading or cover note that states
FDA Modernization Act of 1997:
Concept and Principles,’’ dated October Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
4, 2002, available at: https:// following way: CONFIDENTIAL INFORMATION.’’ The
www.fda.gov/downloads/Medical • Federal eRulemaking Portal: Agency will review this copy, including
Devices/DeviceRegulationandGuidance/ https://www.regulations.gov. Follow the the claimed confidential information, in
GuidanceDocuments/ucm085999.pdf. instructions for submitting comments. its consideration of comments. The
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![Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49379
in § 514.8(b)(3) and the drug made with to be submitted as protocols without Consumer Price Index less food and
the change can be distributed 30 days substantial data in a JINAD file. The energy.
after the resubmission according to Agency will review and act on 90 The workload adjustment will
§ 514.8(b)(3)(iv). The Agency will percent of JINAD submissions continue to be calculated per CVM
review and act on 90 percent of these consisting of protocols without Program Policy and Procedures Manual
reactivated manufacturing supplements substantial data within 75 days after the
1243.3022, except that, for purposes of
within 270 days after the resubmission submission date of the protocol. For
date of a complete submission. If the calculating the workload adjustment, it
potentially more complex comparability
Agency determines that the deficiencies protocols, for example sterile process is agreed to reset the base years to fiscal
remain substantial or new substantial validation protocols, the sponsor should year (FY) 2014 through FY 2018. There
information is provided, prior approval discuss and have Agency concurrence will be no workload adjustment for FY
is required according to regarding the appropriate filing strategy. 2019. Workload adjustments are one-
§ 514.8(b)(3)(v)(A). The Agency will The Agency will continue to allow time adjustments and are calculated
review and act on 90 percent of these two-phased Chemistry, Manufacturing, annually.
reactivated manufacturing supplements and Controls technical section C. Offset Provision and Excess
within 180 days after the resubmission submissions under the JINAD process. Collections
date of a complete submission. The Agency and regulated industry
The Agency will review and act on 90 are committed to improving the review The proposal adds financial flexibility
percent of ‘‘Supplement-Changes Being and business processes that will by eliminating the final year offset of the
Effected’’ manufacturing supplemental facilitate the timely scheduling and over collections provision and making
ANADAs and reactivations submitted conducting of pre-approval inspections any excess collections available to
according to § 514.8(b)(3)(vi) and in (PAIs). To improve the timeliness and enhance the review process in real time.
accordance with Guidance for Industry predictability of foreign PAIs, sponsors
#83, ‘‘Chemistry, Manufacturing, and In addition, the proposal provides
may voluntarily submit: (1) At the authority for the Secretary of Health and
Controls Changes to an Approved beginning of the calendar year, a list of
NADA or ANADA,’’ including Human Services when setting fees to
foreign manufacturing facilities that are reduce a calculated workload
manufacturing changes not requiring specified in an abbreviated application,
prior approval according to adjustment up to the amount of excess
supplemental abbreviated application, collections in the second preceding
§ 514.8(b)(3)(iv), within 270 days after
or generic investigational file and may fiscal year. The first fiscal year this
the submission date.
The Agency will review and act on 90 be subject to foreign PAIs for the
provision could be applied while setting
percent of JINAD study submissions following fiscal year; and (2) a
fees is fiscal year 2021.
within 180 days after the submission notification 30 days prior to submitting
date. an abbreviated application, a D. Impact of AGDUFA III Changes on
A submission is incomplete if it supplemental abbreviated application, User Fee Revenue
would require additional data or or generic investigational file that
informs the Agency that the application The FY 2019 baseline for AGDUFA III
information to enable the Agency to
complete a comprehensive review of the includes a foreign manufacturing is $18,336,340. For each year from FY
study submission and reach a decision facility. Should any changes to the 2020 through FY 2023, the annual
on the issue(s) presented in the annual list occur after its submission to statutory revenue amounts established
submission. If the Agency determines the Agency, the sponsor may provide in section 741(b) of the FD&C Act (21
that the deficiencies are not substantial, the updated information to the Agency. U.S.C. 379j–21(b)) will be further
the Agency will review and act on 90 The Agency will keep a record of the adjusted according to the new statutory
percent of resubmitted JINAD study number of foreign PAIs conducted for provision for the inflation adjuster and
submissions within 60 days after the abbreviated applications, along with the may be further adjusted by the workload
receipt date of a complete study average time for completing the PAIs, adjuster, if applicable.
submission. This shorter review time for and include this information in its
The planned total 5-year revenue for
resubmitted JINAD study submissions is annual performance report. The time for
AGDUFA I was $27,100,000. The
not intended to prevent the use of minor completing the PAI is understood to
planned total 5-year revenue for
amendments during Agency review of a mean the time from the inspection
scheduling request through notification AGDUFA II was $38,100,000, which
study submission. If the Agency also included one-time information
determines that the deficiencies are to the Center for Veterinary Medicine
(CVM) of inspectional findings. technology funding in the amount of
substantial or new substantial
The Agency and regulated industry $850,000 for FY 2014. It is estimated
information is provided, the Agency
will review and act on 90 percent of agree that the use of both formal that the planned total 5-year revenue for
resubmitted JINAD study submissions meetings (e.g., pre-submission AGDUFA III will be $95,000,000.
within 180 days after the receipt date of conferences, workshops) and informal The fee revenue distribution in
a complete study submission. communication by both parties is AGDUFA III will remain the same as
The Agency will review and act on 90 critical to ensure high submission AGDUFA II: 25 percent in application
percent of JINAD submissions quality such that the above performance fees; 37.5 percent in product fees; and
consisting of protocols without goals can be achieved. 37.5 percent in sponsor fees.
sradovich on DSK3GMQ082PROD with NOTICES
substantial data, that the Agency and
B. Inflation Adjuster and Workload Dated: October 20, 2017.
the sponsor consider to be an essential
Adjuster Leslie Kux,
part of the basis for making the decision
to approve or not approve an ANADA The Agency and regulated industry Associate Commissioner for Policy.
or supplemental ANADA, within 75 agree to change the current fixed 4 [FR Doc. 2017–23173 Filed 10–24–17; 8:45 am]
days after the submission date. percent inflation adjuster to a variable BILLING CODE 4164–01–P
The Agency will allow comparability inflation adjuster calculated using
protocols as described in § 514.8(b)(2)(v) payroll cost and benefits and the
VerDate Sep<11>2014 22:06 Oct 24, 2017 Jkt 244001 PO 00000 Frm 00069 Fmt 4703 Sfmt 9990 E:\FR\FM\25OCN1.SGM 25OCN1](https://thefederalregister.org/doc/82_FR_49582/page/3.svg)
Document Created: 2017-10-25 01:16:52
Document Modified: 2017-10-25 01:16:52
| 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; request for comments; extension of comment period. | |
| Dates | FDA is extending the comment period on the AGDUFA reauthorization and draft recommendations. Submit either electronic or written comments on the draft recommendations by November 24, 2017. | |
| Contact | Cassie Ravo, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-6866, [email protected] | |
| FR Citation | 82 FR 49377 |
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