Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability, 71803-71804 [2012-29157]

Download as PDF Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices II. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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, and will be posted to the docket at https:// www.regulations.gov. III. Paperwork Reduction Act of 1995 This 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). New drug applications and abbreviated new drug applications are submitted to FDA under §§ 314.50 and 314.94 (21 CFR 314.50 and 314.94). The collections of information in part 312 and in §§ 314.50 and 314.94 have been approved under OMB control numbers 0910–0014 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: November 28, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–29163 Filed 12–3–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0080] mstockstill on DSK4VPTVN1PROD with Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products—Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the 17:31 Dec 03, 2012 I. Background FDA is announcing the availability of a guidance entitled ‘‘FDA Oversight of PET Drug Products—Questions and Answers.’’ In 1997, Congress passed the Food and Drug Administration Modernization Act (the Modernization Act) (Public Law 105–115). Section 121 of the Modernization Act directed FDA to establish appropriate approval procedures and current good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an implementation timeline was instituted on December 10, 2009, when FDA published regulations that described the minimum CGMP standards that each PET drug manufacturer is to follow during the production of a PET drug (see part 212 (21 CFR part 212)).1 Under the requirements of section 121 of the Modernization Act, within 2 years 1 The SUMMARY: VerDate Mar<15>2010 availability of a guidance entitled ‘‘FDA Oversight of PET Drug Products— Questions and Answers.’’ This guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 this guidance document. Submit electronic comments on the 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: Elizabeth Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6164, Silver Spring, MD 20993–0002, 301– 796–3416. SUPPLEMENTARY INFORMATION: Jkt 229001 regulation, CGMP guidance, and supportive information, including historical documents, are available at https://www.fda.gov/Drugs/Development ApprovalProcess/Manufacturing/ucm085783.htm. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 71803 following that publication date, a new drug application (NDA) or abbreviated new drug application (ANDA) must be submitted for any PET drug marketed for clinical use in the United States. Recognizing that many PET drug producers are unfamiliar with the drug approval process, FDA issued several guidance documents specific to PET drug producers 2 and held a public meeting in March 2011 to assist applicants in preparing NDAs and ANDAs for the three most commonly used PET drugs. Numerous questions have been raised since that public meeting on all aspects of FDA oversight of PET drugs. This guidance is being issued to respond to the questions that have been submitted to date, and it will be revised periodically to respond to additional questions that have been submitted and are expected to be submitted in the future. A draft guidance of the same title was announced in the Federal Register on February 27, 2012 (77 FR 11553), and Docket No. FDA 2012–D–0080 was open for public comment until May 29, 2012. We received one set of comments from industry. We have carefully considered the comments, and where appropriate, we have made corrections, added information, or clarified the information in this guidance in response to the comments or on our own initiative. In addition, we have added six new questions and answers (see questions 63, 64, 65, 66, 88, and 89). This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on the FDA oversight of 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 either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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. 2 We update guidances periodically. To make sure you have the most recent version of a guidance, check FDA’s Drugs guidance Web page at https:// www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm. E:\FR\FM\04DEN1.SGM 04DEN1 71804 Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Paperwork Reduction Act of 1995 This 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). The collections of information in 21 CFR part 314 were approved under OMB control numbers 0910–0001 and 0910–0338; the collections of information in 21 CFR part 312 were approved under OMB control number 0910–0014; the collections of information in part 212 were approved under OMB control number 0910–0667; the collections of information in 21 CFR parts 210 and 211 were approved under 0910–0139; and the collections of information in 21 CFR part 207 were approved under OMB control number 0910–0045. The guidance also refers to collections of information associated with submitting Form FDA 3397 (Prescription Drug User Fee Cover Sheet), approved under OMB control number 0910–0297. 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. Products.’’ The document was published with an incorrect email address. This document corrects that error. Due to this error, FDA is extending the Requests for Oral Presentations registration date from November 27, 2012, to December 7, 2012. Lee Lemley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Silver Spring, MD 20903, 301– 796–3441, Fax: 301–847–8753, email: CDER-AntisepticPreOpPublicMeeting@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Correction In the Federal Register of November 21, 2012, in FR Doc. 2012–28357, on page 69863, the following corrections are made: 1. On page 69863, in the second column, under Contact Person, the email address ‘‘AntisepticPreOpPublic Meeting@fda.hhs.gov’’ is corrected to read ‘‘CDER-AntisepticPreOpPublic Meeting@fda.hhs.gov’’. 2. On page 69863, in the third column, under Requests for Oral Presentations, the date ‘‘November 27, 2012’’ is changed to read ‘‘December 7, 2012. Dated: November 28, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–29166 Filed 12–3–12; 8:45 am] BILLING CODE 4160–01–P Dated: November 28, 2012. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2012–N–0001] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1040] Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments; Correction Food and Drug Administration, Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Device Good Manufacturing Practice Advisory Committee HHS. AGENCY: Notice of public hearing; request for comments; correction. mstockstill on DSK4VPTVN1PROD with Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of November 21, 2012 (77 FR 69863). The document announced a public hearing entitled ‘‘Antiseptic Patient Preoperative Skin Preparation SUMMARY: VerDate Mar<15>2010 17:31 Dec 03, 2012 Jkt 229001 Section 520 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360j), as amended, provides that the DGMPAC shall be composed of two representatives of interests of the device manufacturing industry. The Agency is requesting nominations for nonvoting industry representatives on the DGMPAC. SUPPLEMENTARY INFORMATION: I. Function of DGMPAC DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2012–29157 Filed 12–3–12; 8:45 am] AGENCY: Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. DATES: Any industry organizations interested in participating in the selection of an appropriate nonvoting members to represent industry interests must send a letter stating that interest to FDA by January 3, 2013, for the vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA by January 3, 2013. ADDRESSES: All letters of interest and nominations should be submitted in writing to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Margaret J. Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993, 301–796–5960, margaret.ames@fda.hhs.gov. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Device Good Manufacturing Practice Advisory SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Review proposed regulations issuance regarding good manufacturing practices governing the methods used in, and the facilities and controls used for manufacture, packaging, storage, installation, and servicing of devices, and make recommendations regarding the feasibility and reasonableness of those proposed regulations. The committee also reviews and makes recommendations on proposed guidelines developed to assist the medical device industry in meeting the good manufacturing practice requirements, and provides advice with regard to any petition submitted by a manufacturer for an exemption or variance from good manufacturing practice regulations. II. Qualifications Persons nominated for the DGMPAC should possess appropriate qualifications to understand and contribute to the committee’s work as described in the committee’s function. E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71803-71804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29157]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0080]

Guidance on Food and Drug Administration Oversight of Positron
Emission Tomography Drug Products--Questions and Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``FDA Oversight of PET Drug
Products--Questions and Answers.'' This guidance provides questions and
answers that address nearly all aspects of the FDA approval and
surveillance processes, including application submission, review,
compliance with good manufacturing practices, inspections, registration
and listing, and user fees.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this 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 this
guidance document.
Submit electronic comments on the 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: Elizabeth Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6164, Silver Spring, MD 20993-0002, 301-
796-3416.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance entitled ``FDA
Oversight of PET Drug Products--Questions and Answers.'' In 1997,
Congress passed the Food and Drug Administration Modernization Act (the
Modernization Act) (Public Law 105-115). Section 121 of the
Modernization Act directed FDA to establish appropriate approval
procedures and current good manufacturing practices (CGMP) for PET
drugs. The procedures were finalized and an implementation timeline was
instituted on December 10, 2009, when FDA published regulations that
described the minimum CGMP standards that each PET drug manufacturer is
to follow during the production of a PET drug (see part 212 (21 CFR
part 212)).\1\ Under the requirements of section 121 of the
Modernization Act, within 2 years following that publication date, a
new drug application (NDA) or abbreviated new drug application (ANDA)
must be submitted for any PET drug marketed for clinical use in the
United States.
---------------------------------------------------------------------------

\1\ The regulation, CGMP guidance, and supportive information,
including historical documents, are available at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm.
---------------------------------------------------------------------------

Recognizing that many PET drug producers are unfamiliar with the
drug approval process, FDA issued several guidance documents specific
to PET drug producers \2\ and held a public meeting in March 2011 to
assist applicants in preparing NDAs and ANDAs for the three most
commonly used PET drugs. Numerous questions have been raised since that
public meeting on all aspects of FDA oversight of PET drugs. This
guidance is being issued to respond to the questions that have been
submitted to date, and it will be revised periodically to respond to
additional questions that have been submitted and are expected to be
submitted in the future.
---------------------------------------------------------------------------

\2\ We update guidances periodically. To make sure you have the
most recent version of a guidance, check FDA's Drugs guidance Web
page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
---------------------------------------------------------------------------

A draft guidance of the same title was announced in the Federal
Register on February 27, 2012 (77 FR 11553), and Docket No. FDA 2012-D-
0080 was open for public comment until May 29, 2012. We received one
set of comments from industry. We have carefully considered the
comments, and where appropriate, we have made corrections, added
information, or clarified the information in this guidance in response
to the comments or on our own initiative. In addition, we have added
six new questions and answers (see questions 63, 64, 65, 66, 88, and
89).
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on the FDA oversight of 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 either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. 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.

[[Page 71804]]

and 4 p.m., Monday through Friday, and will be posted to the docket at
https://www.regulations.gov.

III. Paperwork Reduction Act of 1995

This 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). The
collections of information in 21 CFR part 314 were approved under OMB
control numbers 0910-0001 and 0910-0338; the collections of information
in 21 CFR part 312 were approved under OMB control number 0910-0014;
the collections of information in part 212 were approved under OMB
control number 0910-0667; the collections of information in 21 CFR
parts 210 and 211 were approved under 0910-0139; and the collections of
information in 21 CFR part 207 were approved under OMB control number
0910-0045. The guidance also refers to collections of information
associated with submitting Form FDA 3397 (Prescription Drug User Fee
Cover Sheet), approved under OMB control number 0910-0297.

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: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29157 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P

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