Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Food and Drug Administration Form 3671), 70461-70462 [2011-29296]

Download as PDF Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Reclassification Petitions for Medical Devices—21 CFR 860.123 (OMB Control Number 0910–0138)—Extension Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860), subpart C, FDA has responsibility to collect data and information contained in reclassification petitions. The reclassification provisions of the FD&C Act allow any person to petition for reclassification of a device from any of the three classes, i.e., I, II, and III, to another class. The reclassification procedure regulation requires the submission of specific data when a manufacturer is petitioning for reclassification. This includes a ‘‘Supplemental Data Sheet,’’ Form FDA 3427, and a ‘‘Classification 70461 Questionnaire,’’ Form FDA 3429. Both forms contain a series of questions concerning the safety and effectiveness of the device type. Further, the reclassification content regulation (§ 860.123) requires the submission of valid scientific evidence demonstrating that the proposed reclassification will provide a reasonable assurance of safety and effectiveness of the device type for its indications for use. Thus, the reclassification provisions of the FD&C Act serve primarily as a vehicle for manufacturers to seek reclassification from a higher to a lower class, thereby reducing the regulatory requirements applicable to a particular device type, or to seek reclassification from a lower to a higher class, thereby increasing the regulatory requirements applicable to that device type. If approved, petitions requesting classification from class III to class II or class I provide an alternative route to market in lieu of premarket approval for class III devices. If approved, petitions requesting reclassification from class I or II, to a different class, may increase requirements. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 860.123 ................................................................................ 6 1 6 500 3,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. mstockstill on DSK4VPTVN1PROD with NOTICES Based on the last 3 years, and actual reclassification petitions received, FDA anticipates that six petitions will be submitted each year. The time required to prepare and submit a reclassification petition, including the time needed to assemble supporting data, averages 500 hours per petition. This average is based upon estimates by FDA administrative and technical staff who: (1) Are familiar with the requirements for submission of a reclassification petition, (2) have consulted and advised manufacturers on these requirements, and (3) have reviewed the documentation submitted. Dated: November 7, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–29255 Filed 11–10–11; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 19:40 Nov 10, 2011 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0015] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Food and Drug Administration Form 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 (FDA Form 3671)’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 3794, Jonnalynn.Capezzuto@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On June 29, 2011, the Agency submitted a proposed collection of information entitled ‘‘Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (FDA Form 3671)’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information E:\FR\FM\14NON1.SGM 14NON1 70462 Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices collection and has assigned OMB control number 0910–0167. The approval expires on October 31, 2014. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: November 7, 2011. David Dorsey, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2011–29296 Filed 11–10–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSK4VPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on January 20, 2012, from 8 a.m. to 4:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You’’, click on ‘‘Public Meetings at the FDA White Oak Campus’’. Please note that visitors to the White Oak Campus must enter through Bldg. 1. Contact Person: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, (301) 796–9001, FAX: (301) 847–8533, email: ACRHD@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–(800) 741–8138, (301) 443–0572 in the Washington, DC area), and follow the prompts to the desired center or product VerDate Mar<15>2010 19:40 Nov 10, 2011 Jkt 226001 area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 10, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 3, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 notify interested persons regarding their request to speak by January 4, 2012. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 7, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–29181 Filed 11–10–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; 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 sections 552b(c)(4) and 552b(c)(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. Name of Committee: Heart, Lung, and Blood Initial Review Group; Heart, Lung, and Blood Program Project Review Committee. Date: December 2, 2011. Time: 8 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: Double Tree Bethesda Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Notices]
[Pages 70461-70462]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0015]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Orphan Drugs; Common European 
Medicines Agency/Food and Drug Administration Application Form for 
Orphan Medicinal Product Designation (Food and Drug Administration Form 
3671)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Orphan Drugs; Common European 
Medicines Agency/Food and Drug Administration Application Form for 
Orphan Medicinal Product Designation (FDA Form 3671)'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, (301) 796-3794, Jonnalynn.Capezzuto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On June 29, 2011, the Agency submitted a 
proposed collection of information entitled ``Orphan Drugs; Common 
European Medicines Agency/Food and Drug Administration Application Form 
for Orphan Medicinal Product Designation (FDA Form 3671)'' to OMB for 
review and clearance under 44 U.S.C. 3507. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has now approved the information

[[Page 70462]]

collection and has assigned OMB control number 0910-0167. The approval 
expires on October 31, 2014. A copy of the supporting statement for 
this information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: November 7, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-29296 Filed 11-10-11; 8:45 am]
BILLING CODE 4160-01-P

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