Notice Regarding Section 340B of the Public Health Service Act Registration Period, 43342-43343 [2012-17969]

Download as PDF 43342 Federal Register / Vol. 77, No. 142 / Tuesday, July 24, 2012 / Notices sroberts on DSK5SPTVN1PROD with NOTICES affected product, Urobiotic 250 Capsules, and requested a hearing. Despite the filing of timely objections, the amendments were inadvertently not stayed, and succeeding codifications of the antibiotic regulations did not explicitly provide for certification of Urobiotic 250 Capsules. However, FDA permitted Pfizer, Inc., to continue distribution of its product pending resolution of the firm’s hearing request. In July 2010, Pfizer, Inc., voluntarily withdrew its application for Urobiotic (see 75 FR 42455, July 21, 2010), but its hearing request remains pending. In October 2010, FDA sent Pfizer, Inc., a letter requesting that it withdraw or affirm its outstanding hearing request under this docket within 30 days. As of April 1, 2012, Pfizer, Inc., had not responded to FDA. If Pfizer, Inc. (or its successor-in-interest), continues to have an interest in pursuing its hearing request under this docket, the company (or its successor-in-interest) must affirm its hearing request in writing by the date specified in this notice (see DATES). FDA will assume that hearing requests that are not affirmed within that timeframe are no longer being pursued, and will deem them withdrawn. G. Hydrocortisone Acetate and Pramoxine HCl; Docket No. FDA–1988– N–0004 (Formerly 88N–0242) Through DESI review, FDA determined that topical corticosteroids, including hydrocortisone acetate, were effective for symptomatic relief and adjunctive management of various steroid-responsive dermatoses (36 FR 7982, April 28, 1971). In the mid-1970s, FDA approved several products under ANDAs listing hydrocortisone acetate as their sole active ingredient. Subsequently, FDA determined that these products also contained an anesthetic active ingredient, pramoxine HCl. FDA evaluated the effectiveness of the fixed-combination and found no evidence that the pramoxine HCl component contributes an effect to the combination drug (53 FR 25013, July 1, 1988). Thus, FDA proposed to withdraw the ANDAs for these products and offered an opportunity for hearing on its proposal (id). In response to the July 1988 notice, the following companies filed timely hearing requests: Copley Pharmaceutical, Inc., 398 West Second St., Boston, MA 02127, regarding a topical aerosol foam hydrocortisone and pramoxine HCl product (ANDA 89– 440); Ferndale Laboratories, Inc. (now part of Ferndale Pharma Group, Inc., 780 W. Eight Mile Rd., Ferndale, MI 48220), regarding Pramosone lotion (0.5% hydrocortisone acetate) (ANDA VerDate Mar<15>2010 21:06 Jul 23, 2012 Jkt 226001 83–213), Pramosone cream (0.5% hydrocortisone acetate) (ANDA 83–778), Pramosone cream (1.0% hydrocortisone acetate) (ANDA 85–368), Pramosone lotion (1.0% hydrocortisone acetate) (ANDA 85–979), Pramosone lotion (2.5% hydrocortisone acetate) (ANDA 85–980), Pramosone ointment (1% hydrocortisone acetate), Pramosone ointment (2.5% hydrocortisone acetate), Pramosone cream (2.5% hydrocortisone acetate), Enzone cream, Zone-A lotion, Zone-A Forte lotion, Zone-A cream, FEP cream, Dibucort cream, and Proctocream HC; and Reed & Carnrick (now part of Meda Pharmaceuticals, Inc., 265 Davidson Ave., suite 300, Somerset, NH 08873–4120), regarding its topical aerosol foam hydrocortisone and pramoxine HCl products (ANDAs 86– 195 and 86–457). In November 2010, FDA sent letters to Copley Pharmaceutical, Inc.; Ferndale Pharma Group, Inc.; and Meda Pharmaceuticals, Inc., requesting that these companies (or their successors-ininterest) withdraw or affirm their outstanding hearing requests under this docket within 30 days. On January 3, 2011, counsel for Ferndale Laboratories, Inc., and Meda Pharmaceutical, Inc., sent a letter affirming the hearing requests made by both companies. As of April 1, 2012, Copley Pharmaceutical, Inc., had not responded to FDA. If this company (or its successor-in-interest) continues to have an interest in pursuing its hearing request under this docket, the company (or its successor-in-interest) must affirm its hearing request in writing by the date specified in this notice (see DATES). FDA will assume that hearing requests that are not affirmed within that timeframe are no longer being pursued, and will deem them withdrawn. This notice is issued under the Federal Food, Drug, and Cosmetic Act (sections 502 and 505 (21 U.S.C. 352 and 355)). Dated: July 18, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–18015 Filed 7–23–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice Regarding Section 340B of the Public Health Service Act Registration Period Department of Health and Human Services, Health Resources and Services Administration. ACTION: Notice. AGENCY: The Health Resources and Services Administration (HRSA) is issuing this notice to inform stakeholders of the revised deadlines for registration of new covered entities and for adding outpatient facilities and contract pharmacy arrangements to the 340B Drug Pricing Program (340B Program). SUMMARY: Effective Date: October 1, 2012. CDR Krista Pedley, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C–03, Rockville, MD 20857, or by telephone at 301–594– 4353. DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background Section 340B(a)(4) of the Public Health Service Act (PHS) Act (42 U.S.C. 256b) lists the various types of organizations eligible to participate in and purchase discounted drugs under the 340B Program. For a complete list of eligible entities, visit the OPA Web site at https://www.hrsa.gov/ opa.introduction.htm. Eligibility for participation in the 340B Program is limited to the categories of entities specified in this section of the statute. Section 340B(a)(9) of the PHS Act requires the Secretary to notify participating manufacturers of the identity of those entities that meet the definition of covered entity under 340B(a)(4). HRSA published final guidelines on the participation of outpatient facilities in the Federal Register at 59 FR 47884 (Sept. 19, 1994). HRSA published final guidelines on the utilization of Contract Pharmacy Arrangements in the Federal Register at 75 FR 10272 (March 5, 2010). II. Registration Deadlines This notice replaces all previous 340B Program guidance documents addressing the deadline and enrollment period for the 340B Program registration of new covered entities, addition of outpatient facilities and contract pharmacies, including any individual Frm 00115 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1 Federal Register / Vol. 77, No. 142 / Tuesday, July 24, 2012 / Notices 43343 not affected by this notice and will be processed as they are received. and Resources Research, National Institutes of Health, HHS) (A) Registration Period for New Covered Entities and for the Addition of Outpatient Facilities Dated: July 17, 2012. Mary K. Wakefield, Administrator. The registration period for 340B Program registration of new covered entities and the addition of outpatient facilities shall be limited to the following: January 1–January 15 for an effective start date of April 1; April 1– April 15 for an effective start date of July 1; July 1–July 15 for an effective start date of October 1; and October 1– October 15 for an effective start date of January 1. In situations where the 15th falls on a Saturday, Sunday, or Federal holiday, the deadline will be the next business day. Covered entities will not be able to submit registrations outside of these date parameters listed above except when the Secretary has declared a Public Health Emergency. In addition to the complete on-line registration, any required supporting documentation must be submitted on the same day as on-line registration is completed. Incomplete packages will not be considered. For more information on what constitutes a complete package, visit the Office of Pharmacy Affairs (OPA) Web site at www.hrsa.gov/opa. [FR Doc. 2012–17969 Filed 7–23–12; 8:45 am] Dated: July 18, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. BILLING CODE 4165–15–P [FR Doc. 2012–18071 Filed 7–23–12; 8:45 am] (B) Registration Period for Contract Pharmacies sroberts on DSK5SPTVN1PROD with NOTICES correspondence issued by HRSA on the subject. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Jackson Heart Study RFA Review. Date: August 15, 2012. Time: 8:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Tony L Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892–7924, 301–435– 0725, creazzotl@mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; National Health Survey Proposals. Date: August 15, 2012. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Stephanie J Webb, Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892, 301–435–0291, stephanie.webb@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases The registration period for 340B Program registration of contract pharmacies shall be limited to the following: January 1–January 15 for an effective start date of April 1; April 1– April 15 for an effective start date of July 1; July 1–July 15 for an effective start date of October 1; and October 1– October 15 for an effective start date of January 1. In situations where the 15th falls on a Saturday, Sunday, or Federal holiday, the deadline will be the next business day. The contract pharmacy registration process is not complete unless the registration form has been completed in its entirety and the original, signed copy is received by OPA. Signed contract pharmacy registration forms are due to OPA within 15 days from the time online registration was completed. Incomplete packages will not be considered. For more information on what constitutes a complete package, visit the OPA Web site at www.hrsa.gov/ opa. (C) Other Deadlines Deadlines for forms other than those listed above are not affected by this notice. For example, change requests are VerDate Mar<15>2010 21:06 Jul 23, 2012 Jkt 226001 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and (6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00116 Fmt 4703 Sfmt 9990 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; NET–PD Competitive Renewal Review. Date: August 20, 2012. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Chicago O’Hare Airport-Rosemont, 5460 North River Road, Rosemont, IL 60018. Contact Person: William C. Benzing, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892, 301–496–0660, benzingw@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: July 17, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–18070 Filed 7–23–12; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Notices]
[Pages 43342-43343]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Notice Regarding Section 340B of the Public Health Service Act 
Registration Period

AGENCY: Department of Health and Human Services, Health Resources and 
Services Administration.

ACTION: Notice.

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

SUMMARY: The Health Resources and Services Administration (HRSA) is 
issuing this notice to inform stakeholders of the revised deadlines for 
registration of new covered entities and for adding outpatient 
facilities and contract pharmacy arrangements to the 340B Drug Pricing 
Program (340B Program).

DATES: Effective Date: October 1, 2012.

FOR FURTHER INFORMATION CONTACT: CDR Krista Pedley, Director, OPA, HSB, 
HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C-03, Rockville, MD 
20857, or by telephone at 301-594-4353.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 340B(a)(4) of the Public Health Service Act (PHS) Act (42 
U.S.C. 256b) lists the various types of organizations eligible to 
participate in and purchase discounted drugs under the 340B Program. 
For a complete list of eligible entities, visit the OPA Web site at 
https://www.hrsa.gov/opa.introduction.htm. Eligibility for participation 
in the 340B Program is limited to the categories of entities specified 
in this section of the statute. Section 340B(a)(9) of the PHS Act 
requires the Secretary to notify participating manufacturers of the 
identity of those entities that meet the definition of covered entity 
under 340B(a)(4). HRSA published final guidelines on the participation 
of outpatient facilities in the Federal Register at 59 FR 47884 (Sept. 
19, 1994). HRSA published final guidelines on the utilization of 
Contract Pharmacy Arrangements in the Federal Register at 75 FR 10272 
(March 5, 2010).

II. Registration Deadlines

    This notice replaces all previous 340B Program guidance documents 
addressing the deadline and enrollment period for the 340B Program 
registration of new covered entities, addition of outpatient facilities 
and contract pharmacies, including any individual

[[Page 43343]]

correspondence issued by HRSA on the subject.

(A) Registration Period for New Covered Entities and for the Addition 
of Outpatient Facilities

    The registration period for 340B Program registration of new 
covered entities and the addition of outpatient facilities shall be 
limited to the following: January 1-January 15 for an effective start 
date of April 1; April 1-April 15 for an effective start date of July 
1; July 1-July 15 for an effective start date of October 1; and October 
1-October 15 for an effective start date of January 1.
    In situations where the 15th falls on a Saturday, Sunday, or 
Federal holiday, the deadline will be the next business day. Covered 
entities will not be able to submit registrations outside of these date 
parameters listed above except when the Secretary has declared a Public 
Health Emergency. In addition to the complete on-line registration, any 
required supporting documentation must be submitted on the same day as 
on-line registration is completed. Incomplete packages will not be 
considered. For more information on what constitutes a complete 
package, visit the Office of Pharmacy Affairs (OPA) Web site at 
www.hrsa.gov/opa.

(B) Registration Period for Contract Pharmacies

    The registration period for 340B Program registration of contract 
pharmacies shall be limited to the following: January 1-January 15 for 
an effective start date of April 1; April 1-April 15 for an effective 
start date of July 1; July 1-July 15 for an effective start date of 
October 1; and October 1-October 15 for an effective start date of 
January 1.
    In situations where the 15th falls on a Saturday, Sunday, or 
Federal holiday, the deadline will be the next business day. The 
contract pharmacy registration process is not complete unless the 
registration form has been completed in its entirety and the original, 
signed copy is received by OPA.
    Signed contract pharmacy registration forms are due to OPA within 
15 days from the time online registration was completed. Incomplete 
packages will not be considered. For more information on what 
constitutes a complete package, visit the OPA Web site at www.hrsa.gov/opa.

(C) Other Deadlines

    Deadlines for forms other than those listed above are not affected 
by this notice. For example, change requests are not affected by this 
notice and will be processed as they are received.

    Dated: July 17, 2012.
Mary K. Wakefield,
Administrator.
[FR Doc. 2012-17969 Filed 7-23-12; 8:45 am]
BILLING CODE 4165-15-P

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