Draft Guidance for Industry on Process Validation: General Principles and Practices; Reopening of Comment Period, 7237-7238 [E9-3090]

Download as PDF 7237 Federal Register / Vol. 74, No. 29 / Friday, February 13, 2009 / Notices 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. Irradiation in the Production, Processing, and Handling of Food—21 CFR Part 179 (OMB Control Number 0910–0186)—Extension Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, § 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum (or minimum and maximum) energy of radiation emitted by x-ray tube sources. Section 179.21(b)(2) requires that the label or accompanying labeling bear adequate directions for installation and use and a statement supplied by FDA that indicates maximum dose of radiation allowed. Section 179.26(c) requires that the label or accompanying labeling bear a logo and a radiation disclosure statement. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.). The records required by § 179.25(e) are used by FDA inspectors to assess compliance with the regulation that establishes limits within which radiation may be safely used to treat food. The agency cannot ensure safe use without a method to assess compliance with the dose limits, and there are no practicable methods for analyzing most foods to determine whether they have been treated with ionizing radiation and are within the limitations set forth in part 179. Records inspection is the only way to determine whether firms are complying with the regulations for treatment of foods with ionizing radiation. In this request for extension of OMB approval, FDA proposes to include and consolidate into the subject collection of information (OMB control number 0910–0186) the collection of information and associated burden hours from OMB control number 0910– 0549. This inclusion is reflected in the estimated burden reported in table 1 of this document, which has increased by the addition of one recordkeeper in the large processors line, increasing the number of estimated recordkeepers from two to three. Description of Respondents: Respondents are businesses engaged in the irradiation of food. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 179.25(e), large processors 3 300 900 1 900 179.25(e), small processors 4 30 120 1 120 Total cprice-sewell on PRODPC61 with NOTICES 1There 1,020 are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate of burden for the recordkeeping provisions of § 179.25(e) on the agency’s experience regulating the safe use of radiation as a direct food additive. The number of firms who process food using irradiation is extremely limited. FDA estimates that there are three irradiation plants whose business is devoted primarily (i.e., approximately 100 percent) to irradiation of food and other agricultural products. Four other firms also irradiate small quantities of food. FDA estimates that this irradiation accounts for no more than 10 percent of the business for each of these firms. Therefore, the average estimated burden is based on: Three facilities devoting 100 percent of their business to food irradiation (3 x 300 hours = 900 hours for recordkeeping annually); four facilities devoting 10 percent of their business to food irradiation (4 x 30 hours = 120 hours for recordkeeping annually). VerDate Nov<24>2008 15:38 Feb 12, 2009 Jkt 217001 No burden has been estimated for the labeling requirements in §§ 179.21(b)(1) and (b)(2) and 179.26(c) because the information to be disclosed is information that has been supplied by FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not a collection of information. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: February 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–3091 Filed 2–13–09; 8:45 am] HHS. BILLING CODE 4160–01–S PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2008–D–0559] Draft Guidance for Industry on Process Validation: General Principles and Practices; Reopening of Comment Period AGENCY: Food and Drug Administration, ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening until March 16, 2009, the comment period for the draft guidance entitled ‘‘Process Validation: General Principles and Practices.’’ FDA announced the availability of this draft guidance in the Federal Register of November 18, 2008 (73 FR 68431). The initial comment period closes on January 20, 2009. FDA E:\FR\FM\13FEN1.SGM 13FEN1 7238 Federal Register / Vol. 74, No. 29 / Friday, February 13, 2009 / Notices cprice-sewell on PRODPC61 with NOTICES is taking this action in response to a request for an extension of the comment period, due to the holiday season, to allow interested persons sufficient time to review this draft guidance and submit comments. DATES: Submit written or electronic comments by March 16, 2009. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Brian Hasselbalch, Center for Drug Evaluation and Research (HFD– 320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4364, Silver Spring, MD 20993–0002, 301–796–3279; or Grace McNally, Center for Drug Evaluation and Research (HFD– 320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4374, Silver Spring, MD 20993–0002, 301–796–3286; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM–1), Food and Drug Administration, 5515 Security Lane, rm. 7302, Rockville, MD 20852, 301–435–5681; or Dennis Bensley, Center for Veterinary Medicine (HFV–140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276– 8268. SUPPLEMENTARY INFORMATION: I. Background FDA is extending the comment period on a draft guidance for industry entitled ‘‘Process Validation: General Principles and Practices.’’ This guidance outlines the general principles and approaches that FDA considers to be appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (API or drug substance). This guidance incorporates principles and approaches that all manufacturers can use in validating a manufacturing process. FDA issued the draft guidance on November 18, 2008. The initial comment period closes on January 20, 2009. In response to a request for an extension, due to the holiday season, to allow interested persons sufficient time to review this draft guidance and submit comments, FDA has decided to reopen the comment period until March 16, 2009. VerDate Nov<24>2008 15:38 Feb 12, 2009 Jkt 217001 II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/ guidelines.htm, https://www.fda.gov/ cvm/guidance/published.htm, or https:// www.regulations.gov. Dated: February 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–3090 Filed 2–12–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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: Cardiovascular and Renal Drugs Advisory Committee. 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 March 19, 2009, from 8 a.m. to 5 p.m. Location: Marriott Conference Centers, UMUC Inn and Conference Center by Marriott, 3501 University Blvd., East, Adelphi, MD. The hotel telephone number is 301–985–7385. Contact Person: Elaine Ferguson, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane, (for PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, e-mail: elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512533. 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 new drug application (NDA) 22–406, rivaroxaban oral tablets (10 milligrams) Johnson & Johnson Pharmaceutical Research & Development, L.L.C., for the proposed indication for use in prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery. 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/ohrms/ dockets/ac/acmenu.htm, click on the year 2009 and 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 March 5, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Those desiring to make 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 February 25, 2009. 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 E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 74, Number 29 (Friday, February 13, 2009)]
[Notices]
[Pages 7237-7238]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0559]


Draft Guidance for Industry on Process Validation: General 
Principles and Practices; Reopening of Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

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

SUMMARY:  The Food and Drug Administration (FDA) is reopening until 
March 16, 2009, the comment period for the draft guidance entitled 
``Process Validation: General Principles and Practices.'' FDA announced 
the availability of this draft guidance in the Federal Register of 
November 18, 2008 (73 FR 68431). The initial comment period closes on 
January 20, 2009. FDA

[[Page 7238]]

is taking this action in response to a request for an extension of the 
comment period, due to the holiday season, to allow interested persons 
sufficient time to review this draft guidance and submit comments.

DATES:  Submit written or electronic comments by March 16, 2009.

ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
    Brian Hasselbalch, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 
rm. 4364, Silver Spring, MD 20993-0002, 301-796-3279; or
    Grace McNally, Center for Drug Evaluation and Research (HFD-320), 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 
4374, Silver Spring, MD 20993-0002, 301-796-3286; or
    Christopher Joneckis, Center for Biologics Evaluation and Research 
(HFM-1), Food and Drug Administration, 5515 Security Lane, rm. 7302, 
Rockville, MD 20852, 301-435-5681; or
    Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8268.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is extending the comment period on a draft guidance for 
industry entitled ``Process Validation: General Principles and 
Practices.'' This guidance outlines the general principles and 
approaches that FDA considers to be appropriate elements of process 
validation for the manufacture of human and animal drug and biological 
products, including active pharmaceutical ingredients (API or drug 
substance). This guidance incorporates principles and approaches that 
all manufacturers can use in validating a manufacturing process.
    FDA issued the draft guidance on November 18, 2008. The initial 
comment period closes on January 20, 2009. In response to a request for 
an extension, due to the holiday season, to allow interested persons 
sufficient time to review this draft guidance and submit comments, FDA 
has decided to reopen the comment period until March 16, 2009.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/
guidelines.htm, https://www.fda.gov/cvm/guidance/published.htm, or 
https://www.regulations.gov.

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3090 Filed 2-12-09; 8:45 am]
BILLING CODE 4160-01-S

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