New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application, 21694 [2017-09365]

Download as PDF 21694 Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations Dated: May 4, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [FR Doc. 2017–09364 Filed 5–9–17; 8:45 am] [Docket No. FR–5986–C–02] 24 CFR Part 15 BILLING CODE 4164–01–P RIN 2501–AD81 Revision of Freedom of Information Act Regulation; Correction DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: 21 CFR Part 522 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application Food and Drug Administration, HHS. ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA). This action is being taken at the sponsors’ request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective May 22, 2017. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250 has requested that FDA withdraw approval of NADA 009–505 for F.S.H.-P (follicle stimulating hormone) Powder for Injection because the product is no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADA 009–505, and all supplements and amendments thereto, is hereby withdrawn, effective May 22, 2017. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application. jstallworth on DSK7TPTVN1PROD with RULES SUMMARY: Dated: May 4, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–09365 Filed 5–9–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 13:27 May 09, 2017 On January 12, 2017, HUD issued a final rule amending HUD’s Freedom of Information Act (FOIA) regulation to implement the FOIA Improvement Act of 2016, which enacted a range of procedural changes, including a change to the procedures for withholding information and an amendment to one of the nine FOIA exemptions that authorizes an agency to withhold various records from disclosure. After publication, HUD discovered that a portion of the regulation was not published as intended. Specifically, the published rule deleted several of the nine statutory FOIA disclosure exemptions and duplicated another. HUD also noticed minor technical changes required elsewhere in its regulations. This document corrects HUD’s January 12, 2017, final rule and makes the minor technical changes. DATES: Effective: May 10, 2017. FOR FURTHER INFORMATION CONTACT: Helen Goff Foster, Chief Administrative Officer, Office of Administration, Department of Housing and Urban Development, 451 7th Street SW., Room 6100, Washington, DC 20410–0500, telephone number 1–202–402–6838 (this is not a toll-free number). Hearingor speech-impaired individuals may access this number via TTY by calling the toll-free Federal Relay Service at telephone number 1–800–877–8339 (this is a toll-free number). SUPPLEMENTARY INFORMATION: On January 12, 2017 (82 FR 3623), HUD issued a final rule amending HUD’s Freedom of Information Act (FOIA) regulation at 24 CFR part 15 to implement the FOIA Improvement Act of 2016 (Pub. L. 114–185, approved June 30, 2016) (2016 Act). Upon review of the published rule, HUD determined that § 15.107 was not published as intended. The amendatory instruction excluded three of the nine statutory FOIA exemptions (5 U.S.C. 552(b)) and included a duplicate exemption in § 15.107(b). HUD’s January 12, 2017, final rule sought to restructure § 15.107 by adding paragraph (a) to provide that HUD shall SUMMARY: [Docket No. FDA–2017–N–0002] AGENCY: Office of the Secretary, HUD. Final rule; correction. AGENCY: Food and Drug Administration Jkt 241001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 withhold information only if it is reasonably foreseeable that disclosure would harm an interest protected by an exemption, or if disclosure is prohibited by law. HUD also sought to redesignate the undesignated introductory text as paragraph (b), redesignate paragraphs (a) through (i) as (b)(1) through (b)(9), and amend redesignated paragraph (b)(5), the deliberative process privilege, to add a sunset clause after 25 years. As discussed above, HUD’s final rule did not accurately restructure § 15.107 as intended. This final rule restates in whole § 15.107 to reflect the changes required by the 2016 Act to the deliberative process privilege exemption, and restores all other FOIA disclosure exemptions. In addition, HUD is fixing an incorrect Web site link in § 15.101, removing two misplaced words in § 15.105, and correcting the number of days a FOIA requester has to appeal an adverse determination in § 15.109(a), consistent with the change HUD made in § 15.105(d)(2)(iv). List of Subjects in 24 CFR Part 15 Classified information, Courts, Freedom of information, Government employees, Reporting and recordkeeping requirements. Accordingly, 24 CFR part 15 is corrected by making the following correcting amendments: PART 15—PUBLIC ACCESS TO HUD RECORDS UNDER THE FREEDOM OF INFORMATION ACT AND TESTIMONY AND PRODUCTION OF INFORMATION BY HUD EMPLOYEES 1. The authority for part 15 continues to read as follows: ■ Authority: 42 U.S.C. 3535(d), 5 U.S.C. 552. § 15.101 [Amended] 2. In § 15.101(b)(2), remove the link ‘‘https://www/data/gov’’ and add in its place the link ‘‘https://www.data.gov’’. ■ § 15.105 [Amended] 3. In § 15.105, in paragraph (d)(2)(iv) remove the word ‘‘and’’ and in paragraph (d)(2)(v) remove the word ‘‘and’’. ■ 4. Revise § 15.107 to read as follows: ■ § 15.107 Documents generally protected from disclosure. (a) HUD shall withhold information only if HUD reasonably foresees that disclosure would harm an interest protected by an exemption as provided in paragraph (b) of this section, or disclosure is prohibited by law. HUD will consider whether partial disclosure of information is possible whenever E:\FR\FM\10MYR1.SGM 10MYR1

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[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Page 21694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2017-N-0002]


New Animal Drugs; Withdrawal of Approval of a New Animal Drug 
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA). This action is being taken at 
the sponsors' request because these products are no longer manufactured 
or marketed.

DATES: Withdrawal of approval is effective May 22, 2017.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Sioux Biochemical, Inc., 204 Third St. NW., 
Sioux Center, IA 51250 has requested that FDA withdraw approval of NADA 
009-505 for F.S.H.-P (follicle stimulating hormone) Powder for 
Injection because the product is no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of NADA 
009-505, and all supplements and amendments thereto, is hereby 
withdrawn, effective May 22, 2017.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of this application.

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09365 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P

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