Organon USA et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications; Correction, 36310 [2016-13182]

Download as PDF 36310 Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices 5th Floor, Mail Room 5425, Washington, DC 20201; telephone (202) 401–4870; email: lauren.christopher@acf.hhs.gov. It has been determined that approximately $1,230,022 in LIHEAP funds may be available for reallotment during FY 2016. This determination is based on FY 2015 Carryover and Reallotment Reports that showed that seven grantees reported reallotment funds (Tennessee, Puerto Rico, Coyote Valley Band of Pomo Indians, Eastern Shoshone Tribe, Passmaquoddy Tribe at Pleasant Point, Poarch Band of Creek Indians, and The Klamath Tribes). Grantees submitted the FY 2015 Carryover and Reallotment Reports to the Office of Community Services (OCS), as required by regulations applicable to LIHEAP at 45 CFR 96.82. This amount, however, may increase because, as of April 1, 2016, the report for 68 grantees remains pending. The statute allows grantees who have funds unobligated at the end of the federal fiscal year for which they are awarded to request that they be allowed to carry over up to 10 percent of their allotments to the next federal fiscal year. Funds in excess of this amount must be returned to HHS and are subject to reallotment under section 2607(b)(1) of the Act (42 U.S.C. 8626(b)(1)). The amount described in this notice was reported as unobligated FY 2015 funds in excess of the amount that these grantees could carry over to FY 2016. OCS contacted each of the grantees to confirm that the FY 2015 funds indicated in the chart may be reallotted. In accordance with section 2607(b)(3) of the Act (42 U.S.C. 8626(b)(3)), comments will be accepted for a period of 30 days from the date of publication of this notice. After considering any comments submitted, the Chief Executive Officers of LIHEAP grantees will be notified of the final reallotment amount. This decision will be published in the Federal Register. If funds are reallotted, they will be allocated in accordance with section 2604 of the Act (42 U.S.C. 8623) and must be treated by LIHEAP grantees receiving them as an amount appropriated for FY 2016. As FY 2016 funds, they will be subject to all requirements of the Act, including section 2607(b)(2) (42 U.S.C. 8626(b)(2)), which requires that a grantee obligate at least 90 percent of its total block grant allocation for a fiscal year by the end of the fiscal year for which the funds are appropriated, that is, by September 30, 2016. sradovich on DSK3TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 21:02 Jun 03, 2016 Jkt 238001 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993–0002, 301– FY 2015 reallotment 796–3601. amount SUPPLEMENTARY INFORMATION: In the $271,910 Federal Register of Tuesday, October 818,566 13, 2015, appearing on page 61426 in FR Doc. 2015–25922, the following 9,025 correction is made: 37,413 On page 61426, in table 1, the entries for NDAs 016096 and 016097 are 33,602 50,978 removed. ESTIMATED REALLOTMENT AMOUNTS OF FY 2015 LIHEAP FUNDS Grantee name Tennessee .................................. Puerto Rico ................................. Coyote Valley Band of Pomo Indians ........................................ Eastern Shoshone Tribe ............. Passmaquoddy Tribe at Pleasant Point .................................. Poarch Band of Creek Indians ... The Klamath Tribes .................... 8,528 Total ..................................... 1,230,022 Statutory Authority: 42 U.S.C. 8626. Mary M. Wayland, Senior Grants Policy Specialist, Division of Grants Policy, Office of Administration. [FR Doc. 2016–13217 Filed 6–3–16; 8:45 am] Dated: May 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–13182 Filed 6–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4184–80–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2013–N–0797] Food and Drug Administration [Docket No. FDA–2015–N–3432] Organon USA et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 13, 2015 (80 FR 61426). The document announced the withdrawal of approval of 67 new drug applications (NDAs) and 128 abbreviated new drug applications from multiple applicants, effective November 12, 2015. The document indicated that FDA was withdrawing approval of the following two NDAs after receiving a request from the NDA holder, Merck Sharp & Dohme Corp. (Merck), 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889: NDA 016096, MINTEZOL (thiabendazole) Tablets, and NDA 016097, MINTEZOL (thiabendazole) Oral Suspension. Before withdrawal of these NDAs became effective, Merck informed FDA that it did not want approval of the NDAs withdrawn. Because Merck timely requested that approval of these NDAs not be withdrawn, the approval of NDAs 016096 and 016097 is still in effect. FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to FDA regulations for human tissue intended for transplantation. DATES: Submit either electronic or written comments on the collection of information by August 5, 2016. ADDRESSES: You may submit comments 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 E:\FR\FM\06JNN1.SGM 06JNN1

Agencies

[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Page 36310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3432]


Organon USA et al.; Withdrawal of Approval of 67 New Drug 
Applications and 128 Abbreviated New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of October 13, 2015 (80 FR 
61426). The document announced the withdrawal of approval of 67 new 
drug applications (NDAs) and 128 abbreviated new drug applications from 
multiple applicants, effective November 12, 2015. The document 
indicated that FDA was withdrawing approval of the following two NDAs 
after receiving a request from the NDA holder, Merck Sharp & Dohme 
Corp. (Merck), 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889: 
NDA 016096, MINTEZOL (thiabendazole) Tablets, and NDA 016097, MINTEZOL 
(thiabendazole) Oral Suspension. Before withdrawal of these NDAs became 
effective, Merck informed FDA that it did not want approval of the NDAs 
withdrawn. Because Merck timely requested that approval of these NDAs 
not be withdrawn, the approval of NDAs 016096 and 016097 is still in 
effect.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, October 
13, 2015, appearing on page 61426 in FR Doc. 2015-25922, the following 
correction is made:
    On page 61426, in table 1, the entries for NDAs 016096 and 016097 
are removed.

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13182 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P

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