Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability, 8262 [2012-3319]

Download as PDF 8262 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices is reduced because the respondents do not submit a full report for each event they report in a quarterly summary report. The Agency believes that the majority of manufacturers, user facilities, and importers have already established written procedures to document complaints and information to meet the MDR requirements as part of their internal quality control system. There are an estimated 30,000 medical device distributors. Although they do not submit MDR reports, they must maintain records of complaints, under § 803.18(d). The Agency has estimated that on average 220 user facilities, importers, and manufacturers would annually be required to establish new procedures, or revise existing procedures, in order to comply with this provision. Therefore, FDA estimates the onetime burden to respondents for establishing or revising procedures under § 803.17 to be 2,200 hours (220 respondents x 10 hours). For those entities, a one-time burden of 10 hours is estimated for establishing written MDR procedures. The remaining manufacturers, user facilities, and importers, not required to revise their written procedures to comply with this provision, are excluded from the burden because the recordkeeping activities needed to comply with this provision are considered ‘‘usual and customary’’ under 5 CFR 1320.3(b)(2). Under § 803.18, 30,000 respondents represent distributors, importers, and other respondents to this information collection. FDA estimates that it should take them approximately 1.5 hours to complete the recordkeeping requirement for this section. Total hours for this section equal 45,000 hours. Dated: February 9, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–3344 Filed 2–13–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2012–D–0081] Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Mar<15>2010 21:57 Feb 13, 2012 Jkt 226001 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.’’ The draft guidance is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 14, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kyong (Kaye) Kang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2352, Silver Spring, MD 20993, 301–796– 2050. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background FDA is announcing the availability of a draft guidance entitled ‘‘Investigational New Drug Applications for Positron Emission Tomography (PET) drugs.’’ The draft guidance summarizes the IND process for PET drugs, makes recommendations for how to submit an IND, provides advice on expanded access options for investigational PET drugs, and describes the process for requesting permission to charge for an investigational PET drug. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the submission of INDs for PET drugs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). INDs and requests to charge for a drug under an IND are submitted to FDA under part 312 (21 CFR part 312). NDAs and ANDAs are submitted to FDA under §§ 314.50 and 314.94 (21 CFR 314.50 and 3.14.94). The collections of information in part 312 and in §§ 314.50 and 314.94 have been approved under OMB control numbers 0910–0014, 0910–0653, 0910–0651, and 0910–0001. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: February 8, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–3319 Filed 2–13–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0805] Dermatologic and Ophthalmic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Dermatologic and Ophthalmic Drugs E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Notices]
[Page 8262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3319]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0081]


Draft Guidance on Investigational New Drug Applications for 
Positron Emission Tomography Drugs; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Investigational New Drug 
Applications for Positron Emission Tomography (PET) Drugs.'' The draft 
guidance is intended to assist manufacturers of PET drugs in submitting 
investigational new drug applications (INDs).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 14, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Kyong (Kaye) Kang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2352, Silver Spring, MD 20993, 301-796-
2050.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Investigational New Drug Applications for Positron Emission 
Tomography (PET) drugs.'' The draft guidance summarizes the IND process 
for PET drugs, makes recommendations for how to submit an IND, provides 
advice on expanded access options for investigational PET drugs, and 
describes the process for requesting permission to charge for an 
investigational PET drug.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the 
submission of INDs for PET drugs. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). INDs 
and requests to charge for a drug under an IND are submitted to FDA 
under part 312 (21 CFR part 312). NDAs and ANDAs are submitted to FDA 
under Sec. Sec.  314.50 and 314.94 (21 CFR 314.50 and 3.14.94). The 
collections of information in part 312 and in Sec. Sec.  314.50 and 
314.94 have been approved under OMB control numbers 0910-0014, 0910-
0653, 0910-0651, and 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: February 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3319 Filed 2-13-12; 8:45 am]
BILLING CODE 4160-01-P
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