Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 70236-70237 [2015-28789]

Download as PDF jstallworth on DSK7TPTVN1PROD with NOTICES 70236 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices announced the availability of a draft guidance entitled ‘‘Draft Guidance on Qualification of Biomarker— Galactomannan in studies of Treatments of Invasive Aspergillosis.’’ The Agency received one comment during the public comment period which was supportive of the qualification of this biomarker. This guidance finalizes the draft guidance issued in October 2014. This guidance provides qualification recommendations for the use of Galactomannan detection in serum and/ or BAL fluid as the sole microbiological criterion to classify patients with hematologic malignancies and recipients of allogeneic hematopoietic stem cell transplants and who also have radiologic evidence suggestive of invasive fungal infection (Ref. 1) as having probable IA for enrollment in clinical trials. Specifically, this guidance provides the COU for which this biomarker is qualified through the CDER Biomarker Qualification Program. Qualification of this biomarker for this specific COU represents the conclusion that analytically valid measurements of the biomarker can be relied on to have a specific use and interpretable meaning. This biomarker can be used by drug developers for the qualified COU in submission of INDs, NDAs, and BLAs without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker. ‘‘Qualification’’ means that the use of this biomarker in the specific COU is not limited to a single, specific drug development program. Making the qualification recommendations widely known and available for use by drug developers will contribute to drug innovation, thus supporting public health. Innovative and improved Drug Development Tools (DDTs) can help streamline the drug development process, improve the chances for clinical trial success, and yield more information about a treatment and/or disease. DDTs include, but are not limited to, biomarkers, clinical outcome assessments, and animal models. Refer to DDTs Qualification Programs at https://www.fda.gov/Drugs/Development ApprovalProcess/DrugDevelopment ToolsQualificationProgram/default.htm for additional information. In the Federal Register of January 7, 2014 (79 FR 831), FDA announced the availability of a final guidance for industry entitled ‘‘Qualification Process for Drug Development Tools’’ that described the process that would be used to qualify DDTs and to make new DDT qualification recommendations available on FDA’s Web site at https:// VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. The current guidance is an attachment to that final guidance. CDER has initiated this formal qualification process to work with developers of these biomarker DDTs to guide them as they refine and evaluate DDTs for use in the regulatory context. Once qualified, biomarker DDTs will be publicly available for use in any drug development program for the qualified COU. As described in the January 2014 guidance, biomarker DDTs should be developed and reviewed using this process. For more information on FDA’s DDTs Qualification Programs, refer to the following Web page: https:// www.fda.gov/Drugs/Development ApprovalProcess/DrugDevelopment ToolsQualificationProgram/default.htm. 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 for the use of Galactomannan detection in serum and/ or BAL fluid as the sole microbiological criterion to classify patients as having probable IA for enrollment in clinical trials. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. The 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 312.30, 21 CFR 314.50(d)(5), and 21 CFR 314.126(b)(6) have been approved under OMB control numbers 0910–0001 and 0910–0014. III. 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. IV. Reference The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 1. De Pauw, B., T. J. Walsh, J. P. Donnelly, et al., ‘‘Revised Definitions of Invasive Fungal Disease from European Organization for Research and Treatment of Cancer/ Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group,’’ Clinical Infectious Diseases, 46:12, pp. 1813– 1821, 2008. Dated: November 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–28804 Filed 11–12–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0922] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On September 17, 2015, the Agency submitted a proposed collection of information entitled ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals’’ 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 collection and has assigned OMB control number 0910–0789. The approval expires on October 31, 2018. A copy of the supporting statement for this SUMMARY: E:\FR\FM\13NON1.SGM 13NON1 70237 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: November 5, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–28789 Filed 11–12–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Food and Drug Administration [Docket No. FDA–2012–N–0564] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act AGENCY: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Food and Drug Administration, HHS. ACTION: OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0642. Also include the FDA docket number found in brackets in the heading of this document. Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 14, 2015. ADDRESSES: To ensure that comments on the information collection are received, SUMMARY: Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act—(OMB Control Number 0910–0642)–Extension In 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) with respect to serious adverse event reporting for dietary supplements and nonprescription drugs marketed without an approved application. The DSNDCPA also amended the FD&C Act to add section 403(y) (21 U.S.C. 343(y)), which requires the label of a dietary supplement marketed in the United States to include a domestic address or domestic telephone number through which the product’s manufacturer, packer or distributor may receive a report of a serious adverse event associated with the dietary supplement. In the Federal Register of September 1, 2009 (74 FR 45221), we announced the availability of a guidance document entitled, ‘‘Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.’’ The guidance document contains questions and answers related to the labeling requirements in section 403(y) of the FD&C Act and provides guidance to industry on the use of an explanatory statement before the domestic address or telephone number. The guidance document provides our interpretation of the labeling requirements for section 403(y) of the FD&C Act and our views on the information that should be included on the label. We believe that the guidance will enable persons to meet the criteria for labeling that are established in section 403(y) of the FD&C Act. In the Federal Register of August 24, 2015 (80 FR 51278), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents Activity Number of disclosures per respondent Average burden per disclosure Total annual disclosures Total hours Domestic address or phone number labeling requirement (21 U.S.C. 343(y)) ............................................................ FDA recommendation for label statement explaining purpose of domestic address or phone number ................... 1,700 3.27 5,560 0.2 1,112 1,700 3.27 5,560 0.2 1,112 Total .............................................................................. ........................ ........................ ........................ ........................ 2,224 jstallworth on DSK7TPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The labeling requirements of section 403(y) of the FD&C Act became effective on December 22, 2007, although we exercised enforcement discretion until September 30, 2010, to enable all firms to meet the labeling requirements for dietary supplements. At this time, therefore, we expect that all labels required to include the domestic address or telephone number issued in section 403(y) have been revised VerDate Sep<11>2014 17:57 Nov 12, 2015 Jkt 238001 accordingly. Thus our current burden estimate for this information collection applies only to new product labels. In row 1 of Table 1 we estimate the total annual hourly burden necessary to comply with the requirement under section 403(y) of the FD&C Act (21 U.S.C. 343(y)) to be 1,112 hours. Using historical A.C. Nielson Sales Scanner Data, we estimate the number of dietary supplement SKUs for which product PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 sales are greater than zero to be 55,600. Assuming that the flow of new products is 10 percent per year, then each year approximately 5,560 new dietary supplement products are projected to enter the market. Estimating that there are 1,700 dietary supplement manufacturers, re-packagers, re-labelers, and holders of dietary supplements subject to the information collection requirement (using the figure 1,460 as E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70236-70237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28789]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0922]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Food for
Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
for Animals'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On September 17, 2015, the Agency submitted
a proposed collection of information entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals'' 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 collection and has assigned OMB control number 0910-0789.
The approval expires on October 31, 2018. A copy of the supporting
statement for this

[[Page 70237]]

information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

Dated: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28789 Filed 11-12-15; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.