Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction, 80119-80120 [2020-27288]

Download as PDF 80119 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices interstate commerce, but not later than March 11, 2021. Dated: December 7, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–27197 Filed 12–10–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–2197] VistaPharm, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, jbell on DSKJLSW7X2PROD with NOTICES HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of January 11, 2021. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The applicants listed in the table have SUMMARY: informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. Application No. Drug Applicant ANDA 040323 ................................. Prednisolone Syrup, 15 milligrams (mg)/5 milliliters (mL) ..................... ANDA 075782 ................................. ANDA 076188 ................................. Valproic Acid Syrup, 250 mg/5 mL ........................................................ Fosinopril Sodium Tablets, 10 mg, 20 mg, and 40 mg ......................... ANDA 076189 ................................. ANDA 077537 ................................. Mirtazapine Tablets, 15 mg, 30 mg, and 45 mg ................................... Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg .................................... ANDA 077672 ................................. ANDA 085055 ................................. ANDA 087266 ................................. Stavudine Capsules, 15 mg, 20 mg, 30 mg, and 40 mg ...................... Tylenol W/Codeine No. 1 (acetaminophen and codeine phosphate) Tablets, 300 mg; 7.5 mg. Tylenol W/Codeine No. 2 (acetaminophen and codeine phosphate) Tablets, 300 mg; 15 mg. Tylenol W/Codeine No. 3 (acetaminophen and codeine phosphate) Tablets, 300 mg; 30 mg. Tylenol W/Codeine No. 4 (acetaminophen and codeine phosphate) Tablets, 300 mg; 60 mg. Lindane Shampoo, 1% .......................................................................... VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771 Do. Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369 Do. Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520 Do. Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300, Raritan NJ 08869 ANDA 087313 ................................. ANDA 089003 ................................. Lindane Lotion, 1% ................................................................................ Phenytoin Sodium Injection, 50 mg/mL ................................................. Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of January 11, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on January 11, 2021 may continue to be dispensed VerDate Sep<11>2014 23:25 Dec 10, 2020 Jkt 253001 Olta Pharmaceuticals Corp. (an Akorn Company), 1925 West Field Ct., Suite 300, Lake Forest, IL 60045 Do. Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047 until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: December 8, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [Docket No. FDA–2010–D–0529] [FR Doc. 2020–27303 Filed 12–10–20; 8:45 am] Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction AGENCY: BILLING CODE 4160–01–P PO 00000 Food and Drug Administration Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is correcting a notice entitled ‘‘Qualification Process SUMMARY: Frm 00130 Fmt 4703 Sfmt 4703 E:\FR\FM\11DEN1.SGM 11DEN1 80120 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices for Drug Development Tools; Guidance for Industry; Availability’’ that appeared in the Federal Register of November 25, 2020. The document announced the availability of a final guidance for industry and FDA staff that met the 21st Century Cures Act’s requirement to issue guidance on this qualification process and elaborated on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other drug development tools. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: jbell on DSKJLSW7X2PROD with NOTICES Chris Leptak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993–0002, 301–796–0017; or Stephen Ripley, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002; 240– 402–7911. SUPPLEMENTARY INFORMATION: In the Federal Register of November 25, 2020 (85 FR 75334), in FR Doc. 2020–26051, the following correction is made: On page 75336, in the first column, under the heading, ‘‘II. Paperwork Reduction Act of 1995’’, the paragraph is corrected to read: ‘‘While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information pertaining to submissions of investigational new drug applications have been approved under OMB control number 0910–0014; the collections of information pertaining to submissions of new drug applications and abbreviated new drug applications have been approved under OMB control number 0910–0001; and the collections of information pertaining to submissions of biologics license applications in 21 CFR part 601 have been approved under OMB control number 0910–0338.’’ Dated: December 8, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–27288 Filed 12–10–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 23:25 Dec 10, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–0064] Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe Notices; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry #262 entitled ‘‘Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.’’ The guidance provides uniform, consistent process information to industry to facilitate effective and efficient review of pre-consultation submissions for animal food additives or GRAS notices for intended use in animal food. DATES: The announcement of the guidance is published in the Federal Register on December 11, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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’’). PO 00000 Frm 00131 Fmt 4703 Sfmt 4703 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– 2020–D–0064 for ‘‘Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80119-80120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]


Qualification Process for Drug Development Tools; Guidance for 
Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
entitled ``Qualification Process

[[Page 80120]]

for Drug Development Tools; Guidance for Industry; Availability'' that 
appeared in the Federal Register of November 25, 2020. The document 
announced the availability of a final guidance for industry and FDA 
staff that met the 21st Century Cures Act's requirement to issue 
guidance on this qualification process and elaborated on the new 
qualification process and transparency requirements and discusses the 
taxonomy for biomarkers and other drug development tools. The document 
was published with incorrect information in the Paperwork Reduction Act 
of 1995 section. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Chris Leptak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017; or Stephen Ripley, Center for Biologics Evaluation and 
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, 
MD 20993-0002; 240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 25, 2020 
(85 FR 75334), in FR Doc. 2020-26051, the following correction is made:
    On page 75336, in the first column, under the heading, ``II. 
Paperwork Reduction Act of 1995'', the paragraph is corrected to read:
    ``While this guidance contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information pertaining to submissions of investigational new drug 
applications have been approved under OMB control number 0910-0014; the 
collections of information pertaining to submissions of new drug 
applications and abbreviated new drug applications have been approved 
under OMB control number 0910-0001; and the collections of information 
pertaining to submissions of biologics license applications in 21 CFR 
part 601 have been approved under OMB control number 0910-0338.''

    Dated: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27288 Filed 12-10-20; 8:45 am]
BILLING CODE 4164-01-P
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