Submission for OMB Review; Comment Request, 61425-61426 [2015-25924]

Download as PDF 61425 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC–2013–0022; Docket Number NIOSH– 153–B] Issuance of Final Guidance Publications National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of issuance of final guidance publications. AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following 15 Skin Notation Profiles [DHHS (NIOSH) Publication Nos. 2015– 191 to 2015–195 and 2015–226 to 2015– 235]: SUMMARY: Substance(s) Aldrin: http://www.cdc.gov/niosh/docs/ 2015-191/pdfs/f15_snp_aldrin_2015191.pdf. Aniline: http://www.cdc.gov/niosh/ docs/2015-192/pdfs/f15_snp_aniline_ 2015-192.pdf. Azinphos-methyl: http://www.cdc.gov/ niosh/docs/2015-235/pdfs/f15_snp_ 2015-235.pdf. Captafol: http://www.cdc.gov/niosh/ docs/2015-193/pdfs/f15_snp_ captafol_2015-193.pdf. Chlordane: http://www.cdc.gov/niosh/ docs/2015-229/pdfs/f15_snp_2015229.pdf. Dieldrin: http://www.cdc.gov/niosh/ docs/2015-229/pdfs/f15_snp_2015229.pdf. Dinitro-o-cresol: http://www.cdc.gov/ niosh/docs/2015-195/pdfs/f15_snp_ dinitro-o-cresol_2015-195.pdf. Endrin: http://www.cdc.gov/niosh/docs/ 2015-233/pdfs/f15_snp_2015-233.pdf. Methyl parathion: http://www.cdc.gov/ niosh/docs/2015-231/pdfs/f15_snp_ 2015-231.pdf. Nicotine: http://www.cdc.gov/niosh/ docs/2015-234/pdfs/f15_snp_2015234.pdf. Parathion: http://www.cdc.gov/niosh/ docs/2015-232/pdfs/f15_snp_2015232.pdf. Phorate: http://www.cdc.gov/niosh/ docs/2015-230/pdfs/f15_snp_2015230.pdf. Phosdrin: http://www.cdc.gov/niosh/ docs/2015-226/pdfs/f15_snp_2015226.pdf. Tetraethyl dithionopyrophosphate (TEDP): http://www.cdc.gov/niosh/ docs/2015-227/pdfs/f15_snp_2015227.pdf. Tetraethyl pyrophosphate (TEPP): http://www.cdc.gov/niosh/docs/2015228/pdfs/f15_snp_2015-228.pdf. ADDRESSES: These documents may be obtained at the following link: http:// www.cdc.gov/niosh/topics/skin/skinnotation_profiles.html. FOR FURTHER INFORMATION CONTACT: Naomi Hudson, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS C–32, Cincinnati, OH 45226. (513) 533–8388 (not a toll free number). Email: iuz8@cdc.gov. Dated: October 5, 2015. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2015–25974 Filed 10–9–15; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Title IV–E Plan for Foster Care, Adoption Assistance, and, optional, Guardianship Assistance Programs. OMB No.: 0970–0433. Description: A title IV–E plan is required by section 471, part IV–E of the Social Security Act (the Act) for each public child welfare agency requesting Federal funding for foster care, adoption assistance and guardianship assistance under the Act. Section 479B of the Act provides for an Indian tribe, tribal organization or tribal consortium (Tribe) to operate a title IV–E program in the same manner as a State with minimal exceptions. The Tribe must have an approved title IV–E Plan. The title IV– E plan provides assurances the programs will be administered in conformity with the specific requirements stipulated in title IV–E. The plan must include all applicable State or Tribal statutory, regulatory, or policy references and citations for each requirement as well as supporting documentation. A title IV–E agency may use the pre-print format prepared by the Children’s Bureau of the Administration for Children and Families or a different format, on the condition that the format used includes all of the title IV–E plan requirements of the law. Respondents: Title IV–E agencies administering or supervising the administration of the title IV–E programs. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Title IV–E Plan ................................................................................................. 17 of the information collection. Email address: infocollection@acf.hhs.gov. Additional Information mstockstill on DSK4VPTVN1PROD with NOTICES Estimated Total Annual Burden Hours: 272. OMB Comment Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden hours per response 16 Total burden hours 272 recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV. Attn: E:\FR\FM\13OCN1.SGM 13OCN1 61426 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices Desk Officer for the Administration for Children and Families. Notice. The Food and Drug Administration (FDA) is withdrawing approval of 67 new drug applications (NDAs) and 128 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–25924 Filed 10–9–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3432] DATES: Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications AGENCY: ACTION: Food and Drug Administration, HHS. Effective Date: November 12, 2015. FOR FURTHER INFORMATION CONTACT: Silver Spring, MD 20993–0002, 301– 796–3601. The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process 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. SUPPLEMENTARY INFORMATION: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, TABLE 1 Application No. Drug Applicant NDA 001104 ............ Doca (desoxycorticosterone acetate) Injection, 5 milligrams (mg)/milliliter (mL). Alcohol in Dextrose Injection USP, 10 mL/100 mL and 5 grams (g)/100 mL. Hyprotigen (modified protein hydrolysate) Injection, 5% ...... Ureaphil (urea) for Injection, 40 g/vial ................................... Oratrol (dichlorphenamide) Tablets, 50 mg .......................... Organon USA Inc., Subsidiary of Merck Sharp & Dohme Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109. Do. Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045. Alcon Laboratories Inc., 6201 South Freeway, P.O. Box 1959, Fort Worth, TX 76134. G.D. Searle, LLC, 235 East 42nd St., New York, NY 10017. Shire Development Inc., 725 Chesterbrook Blvd., Wayne, PA 19087–5637. B. Braun Medical Inc. Do. Merck Sharp & Dohme Corp., 1 Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889. Do. Baxter Healthcare Corp. 32650 N. Wilson Rd., Round Lake, IL 60073. Do. Do. Do. Do. B. Braun Medical Inc. Hospira, Inc. Do. Merck Sharp & Dohme Corp. Hospira, Inc. B. Braun Medical Inc. MSD Consumer Care, Inc., 556 Morris Ave., Summit, NJ 07901. Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044. B. Braun Medical Inc. Do. NDA 004589 ............ NDA 006170 ............ NDA 012154 ............ NDA 012449 ............ NDA 012699 ............ NDA 012892 ............ Lomotil (atropine sulfate and diphenoxylate hydrochloride (HCl)) Solution 0.025 mg/5 mL and 2.5 mg/5 mL. Uracil Mustard Capsule ......................................................... NDA 014738 ............ NDA 016080 ............ NDA 016096 ............ Mannitol Injection USP, 20% ................................................. Mannitol Injection USP .......................................................... Mintezol (thiabendazole) Tablets .......................................... NDA 016097 ............ NDA 016695 ............ Mintezol (thiabendazole) Oral Suspension ........................... Dextrose Injection, 5% (in Ringer’s) ...................................... NDA NDA NDA NDA NDA NDA NDA NDA NDA NDA NDA Plasma-Lyte M and Dextrose 5% Injection ........................... Plasma-Lyte R Injection ........................................................ Plasma Lyte 148 and Dextrose 5% Injection ........................ Travasol (amino acids) Injection, 10% .................................. Dextrose 5% Injection (in lactated Ringer’s) ......................... Sorbitol-Mannitol Irrigation, 2.7 g/100 mL–540 mg/100 mL .. Serile Urea Injection .............................................................. Clinoril (sulindac) Tablets, 150 mg and 200 mg ................... Novamine (amino acids) Injection ......................................... Dextrose Injection USP, 60% ................................................ Drixoral Non-Drowsy (pseudoephedrine sulfate) ExtendedRelease Tablets, 120 mg. Sulfamethoxazole and Trimethorim Tablets USP ................. 017390 017438 017451 017493 017510 017636 017698 017911 017957 017995 018191 ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ NDA 018242 ............ NDA 018307 ............ mstockstill on DSK4VPTVN1PROD with NOTICES NDA 018258 ............ NDA 018268 ............ Dextrose Injection 5% (in acetated Ringer’s) ........................ Dextrose, Sodium Chloride, and Potassium Chloride Injection USP, 5%. Thyro-Block (potassium iodide tablets USP) ........................ NDA NDA NDA NDA NDA ............ ............ ............ ............ ............ Thyro-Block (potassium iodide solution), 21 mg ................... Calderol (calcifediol) Capsules .............................................. Dextrose and Sodium Chloride Injection, 2.5%/0.9% ........... Nitroglycerin Injection USP, 5 mg/mL ................................... Nizoral (ketoconazole) Tablets, 200 mg ............................... NDA 018684 ............ NDA 018722 ............ NDA 018725 ............ Branchamin (amino acids) Injection, 4% ............................... Sodium Chloride 0.9%, and Potassium Chloride Injection ... Acetated Ringer’s Injection .................................................... 018308 018312 018376 018531 018533 VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. Do. Organon USA Inc., Subsidiary of Merck & Co., Inc. B. Braun Medical Inc. Hospira, Inc. Janssen Pharmaceuticals, Inc., c/o Janssen Research & Development, LLC, 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869–0602. Baxter Healthcare Corp. B. Braun Medical Inc. Do. E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61425-61426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25924]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Title IV-E Plan for Foster Care, Adoption Assistance, and, 
optional, Guardianship Assistance Programs.
    OMB No.: 0970-0433.
    Description: A title IV-E plan is required by section 471, part IV-
E of the Social Security Act (the Act) for each public child welfare 
agency requesting Federal funding for foster care, adoption assistance 
and guardianship assistance under the Act. Section 479B of the Act 
provides for an Indian tribe, tribal organization or tribal consortium 
(Tribe) to operate a title IV-E program in the same manner as a State 
with minimal exceptions. The Tribe must have an approved title IV-E 
Plan. The title IV-E plan provides assurances the programs will be 
administered in conformity with the specific requirements stipulated in 
title IV-E. The plan must include all applicable State or Tribal 
statutory, regulatory, or policy references and citations for each 
requirement as well as supporting documentation. A title IV-E agency 
may use the pre-print format prepared by the Children's Bureau of the 
Administration for Children and Families or a different format, on the 
condition that the format used includes all of the title IV-E plan 
requirements of the law.
    Respondents: Title IV-E agencies administering or supervising the 
administration of the title IV-E programs.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Title IV-E Plan.................................              17               1              16             272
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 272.

Additional Information

    Copies of the proposed collection may be obtained by writing to the 
Administration for Children and Families, Office of Planning, Research 
and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: 
ACF Reports Clearance Officer. All requests should be identified by the 
title of the information collection. Email address: 
infocollection@acf.hhs.gov.

OMB Comment

    OMB is required to make a decision concerning the collection of 
information between 30 and 60 days after publication of this document 
in the Federal Register. Therefore, a comment is best assured of having 
its full effect if OMB receives it within 30 days of publication. 
Written comments and recommendations for the proposed information 
collection should be sent directly to the following: Office of 
Management and Budget, Paperwork Reduction Project, Email: 
OIRA_SUBMISSION@OMB.EOP.GOV. Attn:

[[Page 61426]]

Desk Officer for the Administration for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-25924 Filed 10-9-15; 8:45 am]
 BILLING CODE 4184-01-P