24320 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 

TABLE 7—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS—Continued 

PHS guideline section Description 21 CFR section 

(unless otherwise stated) 

3.1.1 and 3.1.6 .............. Document well-characterized health history and lineage of source 

animals..

312.23(a)(7)(a) and 211.84. 

3.1.8 .............................. Registration with and import permit from the Centers for Disease 

Control and Prevention..

42 CFR 71.53. 

3.2.2 .............................. Document collaboration with accredited microbiology labs .................. 312.52. 

3.2.3 .............................. Procedures to ensure the humane care of animals ............................. 9 CFR parts 1, 2, and 3 and PHS Policy 1. 

3.2.4 .............................. Procedures consistent for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) and consistent with the National 

Research Council’s (NRC) Guide.

AAALAC International Rules of Accreditation 2

and NRC Guide 3. 

3.2.5, 3.4, and 3.4.1 ...... Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record 

standard veterinary care.

211.100 and 211.122. 

3.2.6 .............................. Animal facility SOPs .............................................................................. PHS Policy 1. 

3.3.3 .............................. Validate assay methods ........................................................................ 211.160(a). 

3.6.1 .............................. Procurement and processing of xenografts using documented aseptic 

conditions.

211.100 and 211.122. 

3.6.2 .............................. Develop, implement, and enforce SOPs for procurement and screening processes.211.84(d) and 211.122(c). 

3.6.4 .............................. Communicate to FDA animal necropsy findings pertinent to health of 

recipient.

312.32(c). 

3.7.1 .............................. PHS specimens to be linked to health records; provide to FDA justification for types of tissues, cells, and plasma, and quantities of 

plasma and leukocytes collected.

312.23(a)(6). 

4.1.1 .............................. Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program life-long (justify >2 yrs.); investigator case histories (2 yrs. after investigation is discontinued).312.23(a)(6)(iii)(f) and (g), and 312.62(b) and 

(c). 

4.1.2 .............................. Sponsor to justify amount and type of reserve samples ...................... 211.122. 

4.1.2.2 ........................... System for prompt retrieval of PHS specimens and linkage to medical records (recipient and source animal).312.57(a). 

4.1.2.3 ........................... Notify FDA of a clinical episode potentially representing a xenogeneic 

infection.

312.32. 

4.2.2.1 ........................... Document collaborations (transfer of obligation) .................................. 312.52. 

4.2.3.1 ........................... Develop educational materials (sponsor provides investigators with 

information needed to conduct investigation properly).

312.50. 

4.3 ................................. Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories.312.57 and 312.62(b). 

1The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (https://olaw.nih.gov/policies-laws/phs-policy.htm). 2AAALAC International Rules of Accreditation (https://www.aaalac.org/accreditation-program/rules-of-accreditation/). 3The NRC’s ‘‘Guide for the Care and Use of Laboratory Animals.’’ 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate 

other than to adjust total burden hours 

by one hour, from 60 to 59 total burden 

hours, to address an inadvertent error in 

disclosure burden in the previous 

submissions to OMB. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08737 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0413] 

Baxter Healthcare Corporation, et al.; 

Withdrawal of Approval of 14 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

Health and Human Service (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 14 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 

May 25, 2022. 

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 

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. 


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Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 24321 

Application No. Drug Applicant 

ANDA 075695 ...................... Butorphanol Tartrate Injection, 1 milligram (mg)/milliliter 

(mL), and 2 mg/mL.

Baxter Healthcare Corporation, One Baxter Pkwy., 

Deerfield, IL 60015. 

ANDA 075697 ...................... Butorphanol Tartrate Injection, 2 mg/mL ........................ Do. 

ANDA 077290 ...................... Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 

15 mg, 20 mg, 30 mg.

Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles 

Rock Rd., Bridgeton, MO 63044. 

ANDA 078564 ...................... Granisetron HCl Injection, Equivalent to (EQ) 1 mg 

base/mL (EQ 1 mg base/mL).

Morton Grove Pharmaceuticals Inc., 6451 Main St., 

Morton Grove, IL 60053. 

ANDA 078565 ...................... Granisetron HCl Injection, EQ 4 mg base/4 mL (EQ 1 

mg base/mL).

Do. 

ANDA 078566 ...................... Granisetron HCl Injection, EQ 0.1 mg base/mL (EQ 0.1 

mg base/mL).

Do. 

ANDA 088342 ...................... Fluoxymesterone Tablets, 10 mg ................................... Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., 

Maple Grove, MN 55369. 

ANDA 202032 ...................... Lamivudine Tablets, 150 mg and 300 mg ...................... Aurobindo Pharma USA, Inc., 279 PrincetonHightstown Rd., East Windsor, NJ 08520. 

ANDA 205322 ...................... Efavirenz Tablets, 600 mg .............................................. Do. 

ANDA 205690 ...................... Choline C–11 Injection, 4–100 millicurie/mL .................. University of Texas MD Anderson Cancer Center, 1881 

East Rd., Unit 1903, Houston, TX 77054. 

ANDA 207653 ...................... Rosuvastatin Calcium Tablets, EQ 5 mg base, EQ 10 

mg base, EQ 20 mg base, EQ 40 mg base.

SciRegs International, Inc., 6333 Summercrest Dr., Columbia, MD 21045. 

ANDA 208199 ...................... Azelastine HCl Metered Spray, 0.2055 mg/spray .......... Amneal Pharmaceuticals LLC, 50 Horseblock Rd., 

Brookhaven, NY 11719. 

ANDA 210032 ...................... Azelastine HCl Metered Spray, 0.2055 mg/spray .......... Akorn Operating Company LLC, 1925 West Field Ct., 

Suite 300, Lake Forest, IL 60045. 

ANDA 211461 ...................... Bosentan Tablets, 62.5 mg and 125 mg ........................ Syneos Health Global Headquarters, 1030 Sync St., 

Third Floor, Morrisville, NC 27560. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of May 25, 2022. 

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 May 25, 2022 may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08744 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0801] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export Notification 

and Recordkeeping Requirements 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by May 25, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0482. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Export Notification and Recordkeeping 

Requirements 

OMB Control Number 0910–0482— 

Extension 

Sections 801 and 802 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 381 and 382) charge the 

Secretary of Health and Human 

Services, through FDA, with the 

responsibility of helping to ensure that 

exports of unapproved new drugs, 

biologics, devices, animal drugs, food, 

cosmetics, and tobacco products that are 

not to be sold in the United States meet 

the requirements of the country to 

which the product is to be exported. 

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or offered for sale in domestic 

commerce in the United States as 

allowed under section 801(e) of the 

FD&C Act. In general, the notification 


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