82 FR 49380 - Animal 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 | 49380-49382 | |
| FR Document | 2017-23172 |
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)] [Notices] [Pages 49380-49382] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23172] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal 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 Drug User Fee Act (ADUFA) 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 ADUFA 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 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 [[Page 49381]] 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-0656 for ``Animal 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 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 ADUFA, which authorizes FDA to collect user fees and use them for the process of reviewing new animal drug applications and associated submissions. 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 for future fiscal years. Section 740A(d)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j- 13(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 (ADUFA IV), we do the following: (1) Present the recommendation 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 46503), 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 ADUFA IV Performance Goals and Procedures Letter and a summary of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.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 ADUFA IV 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 new animal drug applications (NADAs). Beginning October 1, 2018, all applications and submissions under section 512(b) and 571 of the FD&C Act (21 U.S.C. 360b(b) and 21 U.S.C. 360ccc, respectively) must be submitted to the Agency electronically using the eSubmitter tool. The Agency will review and act on 90 percent of ``Supplement- Changes Being Effected'' manufacturing supplemental NADAs and reactivations submitted according to Sec. 514.8(b)(3)(vi) (21 CFR 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 180 days after the submission date. All other application and submission performance goals will remain the same as ADUFA III. The Agency commits to working on implementation of the United States-European Union Good Manufacturing [[Page 49382]] Practice Inspection Mutual Recognition Agreement. All other commitments related to pre-approval inspections will remain the same as ADUFA III. The Agency will review and act on 90 percent of qualifying Animal Drug Availability Act (ADAA) combination medicated feed applications within 60 days after the submission date when all of the following conditions are met: Basic regulatory requirements for an ADAA combination medicated feed application has been met as outlined in 21 CFR 514.4(c)(2)(ii). A presubmission conference has been conducted and either: [cir] No data (no tissue residue non-interference study is required) are needed and this agreement is documented in the memorandum of conference for the presubmission conference; or [cir] A justification for not conducting a tissue residue non- interference study has been submitted, reviewed, and found acceptable under an investigational new animal drug (INAD), prior to the submission of the ADAA combination medicated feed application; or [cir] A tissue residue non-interference study has been submitted, reviewed, and found acceptable under an INAD, prior to the submission of the ADAA combination medicated feed application. No effectiveness or target animal safety data are required. No manufacturing data requirements--sponsor can address in meeting assay non-interference, but data submission is not required. All other information is referenced to previous drug experience reports. Sponsor makes submission and it includes: Representative (Blue Bird) labeling, Veterinary Feed Directive (if applicable). Includes a request for categorical exclusion from the need to prepare an environmental assessment (EA); i.e., no EA required. Reference to presubmission conference. Right of reference (if applicable) to NADA(s) not owned by the filing sponsor of the ADAA combination medicated feed application has been received by the Agency. The Agency will review and act on 90 percent of ADAA combination medicated feed applications within 100 days for those applications accepted for the 60-day timeframe and there is a need for minor amendments. If any of the above conditions cannot be met, the ADAA combination medicated feed application performance metric will be placed in the original NADA application cohort with a 180-day review timeframe. The Agency will review and act on 90 percent of resubmissions of previously completed Environmental Impact technical sections within 60 days after the submission date where: A categorical exclusion was issued; All other technical sections have been submitted; and Information contained in the other technical sections reveals a change in the conditions of use of the previously issued categorical exclusion. The Agency will conduct 90 percent of qualifying presubmission conferences within a 60-day timeframe when all of the following conditions are met: All background materials, including presentations, have been submitted, and A complete agenda has been agreed upon by the Agency and the sponsor. A sponsor and the Agency can mutually agree to exclude a particular presubmission conference from this performance goal. If a sponsor accepts a date beyond the 60-day timeframe for their scheduling purposes or is unable to meet with the Agency on Agency available dates, the submission will be excluded from the presubmission conference cohort. The Agency will commence 90 percent of tissue residue method demonstrations within 120 days of completion of the 3-hour meeting process or within 200 days from the receipt of a submission that supports a single laboratory validation tissue residue method demonstration. B. Inflation Adjuster and Workload Adjuster The inflation adjuster will remain the same as for ADUFA III. The workload adjustment will continue to be calculated per Center for Veterinary Medicine Program Policy and Procedures Manual 1243.3022, except that, for purposes of calculating the workload adjustment, it has been 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 over collections provision and making any excess collections available to enhance the review process in real time. The proposal provides authority for the Secretary of Health and Human Services (the Secretary) 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 FY 2021. Likewise, the proposal also provides authority to the Secretary to reduce an increase in fees to recover a shortfall in collections in a preceding year (after 2018) by any remaining prior year excess collections not already applied for purposes of reducing fee increases. D. Impact of ADUFA IV Enhancements on User Fee Revenue The FY 2019 baseline for ADUFA IV is $30,331,240, which includes a $400,000 one-time cost for information technology enhancement. 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 by the inflation adjuster, the workload adjuster, if applicable, and will include $900,000 per year for tissue method trials. The total 5-year revenue planned for ADUFA I was $47,000,000. The total 5-year revenue planned for ADUFA II was $98,000,000. The total 5- year revenue planned for ADUFA III was $114,000,000. It is estimated that the total 5-year revenue for ADUFA IV will be $150,000,000. The fee revenue distribution in ADUFA IV will remain the same as ADUFA III: 20 percent from application fees; 27 percent from product fees; 26 percent from establishment fees; and 27 percent from sponsor fees. Dated: October 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-23172 Filed 10-24-17; 8:45 am] BILLING CODE 4164-01-P
![49380 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
DEPARTMENT OF HEALTH AND A person may petition the Agency to labeling for this drug product should be
HUMAN SERVICES determine, or the Agency may revised to meet current standards, the
determine on its own initiative, whether Agency will advise ANDA applicants to
Food and Drug Administration a listed drug was withdrawn from sale submit such labeling.
[Docket No. FDA–2017–P–0840] for reasons of safety or effectiveness. Dated: October 17, 2017.
This determination may be made at any
Leslie Kux,
Determination That OVRETTE time after the drug has been withdrawn
Associate Commissioner for Policy.
(Norgestrel) Tablet, 0.075 Milligrams, from sale, but must be made prior to
FDA’s approval of an ANDA that refers [FR Doc. 2017–23125 Filed 10–24–17; 8:45 am]
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness to the listed drug (§ 314.161 (21 CFR BILLING CODE 4164–01–P
314.161)). FDA may not approve an
AGENCY: Food and Drug Administration, ANDA that does not refer to a listed
HHS. drug. DEPARTMENT OF HEALTH AND
ACTION: Notice. OVRETTE (norgestrel) tablet, 0.075 HUMAN SERVICES
mg, is the subject of NDA 017031, held
SUMMARY: The Food and Drug Food and Drug Administration
by HRA Pharma and initially approved
Administration (FDA or Agency) has
on October 23, 1973. OVRETTE is [Docket No. FDA–2011–N–0656]
determined that OVRETTE (norgestrel)
indicated for the prevention of
tablet, 0.075 milligrams (mg), was not Animal Drug User Fee Act;
pregnancy in women.
withdrawn from sale for reasons of OVRETTE (norgestrel) tablet, 0.075 Recommendations; Request for
safety or effectiveness. This mg, was discontinued from U.S. Comments; Extension of Comment
determination will allow FDA to distribution on June 7, 2005, and is Period
approve abbreviated new drug currently listed in the ‘‘Discontinued
applications (ANDAs) for norgestrel AGENCY: Food and Drug Administration,
Drug Product List’’ section of the Orange
tablet, 0.075 mg, if all other legal and HHS.
Book.
regulatory requirements are met. The Weinberg Group submitted a ACTION: Notice of availability; request
FOR FURTHER INFORMATION CONTACT: citizen petition dated February 8, 2017 for comments; extension of comment
Daniel Gottlieb, Center for Drug (Docket No. FDA–2017–P–0840), under period.
Evaluation and Research, Food and 21 CFR 10.30, requesting that the
Drug Administration, 10903 New SUMMARY: The Food and Drug
Agency determine whether OVRETTE Administration (FDA or the Agency) is
Hampshire Ave., Bldg. 51, Rm. 6217, (norgestrel) tablet, 0.075 mg, was
Silver Spring, MD 20993–0002, 301– announcing the availability of the
withdrawn from sale for reasons of Animal Drug User Fee Act (ADUFA)
796–6650. safety or effectiveness.
reauthorization draft recommendations
SUPPLEMENTARY INFORMATION: In 1984, After considering the citizen petition
and extending the comment period to
Congress enacted the Drug Price and reviewing Agency records and
based on the information we have at this allow interested persons 30 days to
Competition and Patent Term
time, FDA has determined under submit comments on these draft
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which § 314.161 that OVRETTE (norgestrel) recommendations.
authorized the approval of duplicate tablet, 0.075 mg, was not withdrawn DATES: FDA is extending the comment
versions of drug products under an from sale for reasons of safety or period on the ADUFA reauthorization
ANDA procedure. ANDA applicants effectiveness. The petitioner has and draft recommendations. Submit
must, with certain exceptions, show that identified no data or other information either electronic or written comments
the drug for which they are seeking suggesting that OVRETTE (norgestrel) on the draft recommendations by
approval contains the same active tablet, 0.075 mg, was withdrawn for November 24, 2017.
ingredient in the same strength and reasons of safety or effectiveness. We ADDRESSES: You may submit comments
dosage form as the ‘‘listed drug,’’ which have carefully reviewed our files for as follows. Please note that late,
is a version of the drug that was records concerning the withdrawal of untimely filed comments will not be
previously approved. ANDA applicants OVRETTE (norgestrel) tablet, 0.075 mg, considered. Electronic comments must
do not have to repeat the extensive from sale. We have also independently be submitted on or before November 24,
clinical testing otherwise necessary to evaluated relevant literature and data 2017. The https://www.regulations.gov
gain approval of a new drug application for possible postmarketing adverse electronic filing system will accept
(NDA). events. We have found no information comments until midnight Eastern Time
The 1984 amendments include what that would indicate that this drug at the end November 24, 2017.
is now section 505(j)(7) of the Federal product was withdrawn from sale for Comments received by mail/hand
Food, Drug, and Cosmetic Act (21 U.S.C. reasons of safety or effectiveness. delivery/courier (for written/paper
355(j)(7)), which requires FDA to Accordingly, the Agency will submissions) will be considered timely
publish a list of all approved drugs. continue to list OVRETTE (norgestrel) if they are postmarked or the delivery
FDA publishes this list as part of the tablet, 0.075 mg, in the ‘‘Discontinued service acceptance receipt is on or
‘‘Approved Drug Products With Drug Product List’’ section of the Orange before that date.
Therapeutic Equivalence Evaluations,’’ Book. The ‘‘Discontinued Drug Product
which is known generally as the List’’ delineates, among other items, Electronic Submissions
‘‘Orange Book.’’ Under FDA regulations, drug products that have been
sradovich on DSK3GMQ082PROD with NOTICES
Submit electronic comments in the
drugs are removed from the list if the discontinued from marketing for reasons following way:
Agency withdraws or suspends other than safety or effectiveness. • Federal eRulemaking Portal:
approval of the drug’s NDA or ANDA ANDAs that refer to this drug product https://www.regulations.gov. Follow the
for reasons of safety or effectiveness or may be approved by the Agency as long instructions for submitting comments.
if FDA determines that the listed drug as they meet all other legal and Comments submitted electronically,
was withdrawn from sale for reasons of regulatory requirements for the approval including attachments, to https://
safety or effectiveness (21 CFR 314.162). of ANDAs. If FDA determines that www.regulations.gov will be posted to
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![49382 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
Practice Inspection Mutual Recognition NADA application cohort with a 180- adjustment up to the amount of excess
Agreement. All other commitments day review timeframe. collections in the second preceding
related to pre-approval inspections will The Agency will review and act on 90 fiscal year. The first fiscal year this
remain the same as ADUFA III. percent of resubmissions of previously provision could be applied while setting
The Agency will review and act on 90 completed Environmental Impact fees is FY 2021. Likewise, the proposal
percent of qualifying Animal Drug technical sections within 60 days after also provides authority to the Secretary
Availability Act (ADAA) combination the submission date where: to reduce an increase in fees to recover
medicated feed applications within 60 • A categorical exclusion was issued; a shortfall in collections in a preceding
days after the submission date when all • All other technical sections have year (after 2018) by any remaining prior
of the following conditions are met: been submitted; and year excess collections not already
• Basic regulatory requirements for an • Information contained in the other applied for purposes of reducing fee
ADAA combination medicated feed technical sections reveals a change in increases.
application has been met as outlined in the conditions of use of the previously
issued categorical exclusion. D. Impact of ADUFA IV Enhancements
21 CFR 514.4(c)(2)(ii).
on User Fee Revenue
• A presubmission conference has The Agency will conduct 90 percent
been conducted and either: of qualifying presubmission conferences The FY 2019 baseline for ADUFA IV
Æ No data (no tissue residue non- within a 60-day timeframe when all of is $30,331,240, which includes a
interference study is required) are the following conditions are met: $400,000 one-time cost for information
needed and this agreement is • All background materials, including technology enhancement. For each year
documented in the memorandum of presentations, have been submitted, and from FY 2020 through FY 2023, the
conference for the presubmission • A complete agenda has been agreed annual statutory revenue amounts
conference; or upon by the Agency and the sponsor. established in section 741(b) of the
Æ A justification for not conducting a A sponsor and the Agency can FD&C Act (21 U.S.C. 379j–21(b)) will be
tissue residue non-interference study mutually agree to exclude a particular further adjusted by the inflation
has been submitted, reviewed, and presubmission conference from this adjuster, the workload adjuster, if
found acceptable under an performance goal. If a sponsor accepts a applicable, and will include $900,000
investigational new animal drug (INAD), date beyond the 60-day timeframe for per year for tissue method trials.
prior to the submission of the ADAA their scheduling purposes or is unable The total 5-year revenue planned for
combination medicated feed to meet with the Agency on Agency ADUFA I was $47,000,000. The total 5-
application; or available dates, the submission will be year revenue planned for ADUFA II was
Æ A tissue residue non-interference excluded from the presubmission $98,000,000. The total 5-year revenue
study has been submitted, reviewed, conference cohort. planned for ADUFA III was
and found acceptable under an INAD, The Agency will commence 90 $114,000,000. It is estimated that the
prior to the submission of the ADAA percent of tissue residue method total 5-year revenue for ADUFA IV will
combination medicated feed demonstrations within 120 days of be $150,000,000.
application. completion of the 3-hour meeting The fee revenue distribution in
• No effectiveness or target animal process or within 200 days from the ADUFA IV will remain the same as
safety data are required. receipt of a submission that supports a ADUFA III: 20 percent from application
• No manufacturing data single laboratory validation tissue fees; 27 percent from product fees; 26
requirements—sponsor can address in residue method demonstration. percent from establishment fees; and 27
meeting assay non-interference, but data percent from sponsor fees.
B. Inflation Adjuster and Workload
submission is not required. Dated: October 20, 2017.
• All other information is referenced Adjuster
Leslie Kux,
to previous drug experience reports. The inflation adjuster will remain the
Associate Commissioner for Policy.
• Sponsor makes submission and it same as for ADUFA III.
The workload adjustment will [FR Doc. 2017–23172 Filed 10–24–17; 8:45 am]
includes: Representative (Blue Bird)
labeling, Veterinary Feed Directive (if continue to be calculated per Center for BILLING CODE 4164–01–P
applicable). Veterinary Medicine Program Policy
• Includes a request for categorical and Procedures Manual 1243.3022,
except that, for purposes of calculating DEPARTMENT OF HEALTH AND
exclusion from the need to prepare an
the workload adjustment, it has been HUMAN SERVICES
environmental assessment (EA); i.e., no
EA required. agreed to reset the base years to fiscal Food and Drug Administration
• Reference to presubmission year (FY) 2014 through FY 2018. There
conference. will be no workload adjustment for FY [Docket No. FDA–2016–D–2021]
• Right of reference (if applicable) to 2019. Workload adjustments are one-
NADA(s) not owned by the filing time adjustments and are calculated Deciding When To Submit a 510(k) for
sponsor of the ADAA combination annually. a Software Change to an Existing
medicated feed application has been Device; Guidance for Industry and
C. Offset Provision and Excess Food and Drug Administration Staff;
received by the Agency.
The Agency will review and act on 90 Collections Availability
percent of ADAA combination The proposal adds financial flexibility AGENCY: Food and Drug Administration,
by eliminating the final year offset of
sradovich on DSK3GMQ082PROD with NOTICES
medicated feed applications within 100 HHS.
days for those applications accepted for over collections provision and making ACTION: Notice of availability.
the 60-day timeframe and there is a any excess collections available to
need for minor amendments. enhance the review process in real time. SUMMARY: The Food and Drug
If any of the above conditions cannot The proposal provides authority for the Administration (FDA or Agency) is
be met, the ADAA combination Secretary of Health and Human Services announcing the availability of the
medicated feed application performance (the Secretary) when setting fees to guidance entitled ‘‘Deciding When to
metric will be placed in the original reduce a calculated workload Submit a 510(k) for a Software Change
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Document Created: 2017-10-25 01:17:28
Document Modified: 2017-10-25 01:17:28
| 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 ADUFA 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 49380 |
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