83_FR_5130 83 FR 5106 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability; Correction

83 FR 5106 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 24 (February 5, 2018)

Page Range5106-5107
FR Document2018-02181

The Food and Drug Administration is correcting a notice entitled ``Hazard Analysis and Risk- Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of January 23, 2018. The document announced the availability of a draft guidance for industry #245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' The document was published with the incorrect docket number. This document corrects that error.

Federal Register, Volume 83 Issue 24 (Monday, February 5, 2018) 
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5106-5107]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0388]


Hazard Analysis and Risk-Based Preventive Controls for Food for 
Animals; Draft Guidance for Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Hazard Analysis and Risk-

[[Page 5107]]

Based Preventive Controls for Food for Animals; Draft Guidance for 
Industry; Availability'' that appeared in the Federal Register of 
January 23, 2018. The document announced the availability of a draft 
guidance for industry #245 entitled ``Hazard Analysis and Risk-Based 
Preventive Controls for Food for Animals.'' The document was published 
with the incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, January 
23, 2018 (83 FR 3163), in FR Doc. 2018-01126, on page 3163, the 
following correction is made:
    1. On page 3163, in the first column, in the header of the 
document, the docket number is corrected to read ``FDA-2018-D-0388''.

    Dated: January 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02181 Filed 2-2-18; 8:45 am]
 BILLING CODE 4164-01-P

5106 Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices https://www.regulations.gov. Submit review period may count toward the This determination of the regulatory both copies to the Dockets Management actual amount of extension that the review period establishes the maximum Staff. If you do not wish your name and Director of USPTO may award (for potential length of a patent extension. contact information to be made publicly example, half the testing phase must be However, the USPTO applies several available, you can provide this subtracted as well as any time that may statutory limitations in its calculations information on the cover sheet and not have occurred before the patent was of the actual period for patent extension. in the body of your comments and you issued), FDA’s determination of the In its applications for patent extension, must identify this information as length of a regulatory review period for this applicant seeks 428 days, 606 days, ‘‘confidential.’’ Any information marked a human drug product will include all or 431 days of patent term extension. as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase III. Petitions except in accordance with§ 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). CFR 10.20) and other applicable FDA has approved for marketing the Anyone with knowledge that any of disclosure law. For more information human drug product VIBERZI the dates as published are incorrect may about FDA’s posting of comments to (eluxadoline). VIBERZI is indicated in submit either electronic or written public dockets, see 80 FR 56469, adults for the treatment of irritable comments and, under 21 CFR 60.24, ask September 18, 2015, or access the bowel syndrome with diarrhea. for a redetermination (see DATES). information at: https://www.gpo.gov/ Subsequent to this approval, the USPTO Furthermore, as specified in § 60.30 (21 fdsys/pkg/FR-2015-09-18/pdf/2015- received patent term restoration CFR 60.30), any interested person may 23389.pdf. applications for VIBERZI (U.S. Patent petition FDA for a determination Docket: For access to the docket to Nos. 7,741,356; 8,344,011; and regarding whether the applicant for read background documents or the 8,609,709) from Janssen Pharmaceutica, extension acted with due diligence electronic and written/paper comments N.V., and the USPTO requested FDA’s during the regulatory review period. To received, go to http:// assistance in determining the patents’ meet its burden, the petition must www.regulations.gov and insert the comply with all the requirements of eligibility for patent term restoration. In docket number, found in brackets in the § 60.30, including but not limited to: a letter dated August 12, 2016, FDA heading of this document, into the must be timely (see DATES), must be advised the USPTO that this human ‘‘Search’’ box and follow the prompts filed in accordance with § 10.20, must drug product had undergone a and/or go to the Dockets Management contain sufficient facts to merit an FDA regulatory review period and that the Staff, 5630 Fishers Lane, Rm. 1061, investigation, and must certify that a approval of VIBERZI represented the Rockville, MD 20852. true and complete copy of the petition first permitted commercial marketing or has been served upon the patent FOR FURTHER INFORMATION CONTACT: use of the product. Thereafter, the applicant. (See H. Rept. 857, part 1, 98th Beverly Friedman, Office of Regulatory USPTO requested that FDA determine Cong., 2d sess., pp. 41–42, 1984.) Policy, Food and Drug Administration, the product’s regulatory review period. Petitions should be in the format 10903 New Hampshire Ave., Bldg. 51, II. Determination of Regulatory Review specified in 21 CFR 10.30. Rm. 6250, Silver Spring, MD 20993, Period Submit petitions electronically to 301–796–3600. https://www.regulations.gov at Docket SUPPLEMENTARY INFORMATION: FDA has determined that the Nos. FDA–2013–S–0610. Submit written applicable regulatory review period for I. Background petitions (two copies are required) to the VIBERZI is 2,716 days. Of this time, Dockets Management Staff (HFA–305), The Drug Price Competition and 2,381 days occurred during the testing Food and Drug Administration, 5630 Patent Term Restoration Act of 1984 phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD (Pub. L. 98–417) and the Generic while 335 days occurred during the 20852. Animal Drug and Patent Term approval phase. These periods of time were derived from the following dates: Dated: January 30, 2018. Restoration Act (Pub. L. 100–670) generally provide that a patent may be 1. The date an exemption under Leslie Kux, extended for a period of up to 5 years section 505(i) of the Federal Food, Drug, Associate Commissioner for Policy. so long as the patented item (human and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2018–02187 Filed 2–2–18; 8:45 am] drug product, animal drug product, U.S.C. 355(i)) became effective: BILLING CODE 4164–01–P medical device, food additive, or color December 21, 2007. FDA has verified additive) was subject to regulatory the applicant’s claim that December 21, review by FDA before the item was 2007, is the date the investigational new DEPARTMENT OF HEALTH AND marketed. Under these acts, a product’s drug application (IND) became effective. HUMAN SERVICES regulatory review period forms the basis 2. The date the application was initially submitted with respect to the Food and Drug Administration for determining the amount of extension an applicant may receive. human drug product under section [Docket No. FDA–2018–D–0388] A regulatory review period consists of 505(b) of the FD&C Act: June 27, 2014. two periods of time: A testing phase and The applicant claims June 26, 2014, as Hazard Analysis and Risk-Based an approval phase. For human drug the date the new drug application Preventive Controls for Food for products, the testing phase begins when (NDA) for VIBERZI was initially Animals; Draft Guidance for Industry; the exemption to permit the clinical submitted. However, FDA records Availability; Correction investigations of the drug becomes indicate that NDA 206940 was sradovich on DSK3GMQ082PROD with NOTICES AGENCY: Food and Drug Administration, effective and runs until the approval submitted on July 27, 2014, which is HHS. phase begins. The approval phase starts considered to be the NDA initially ACTION: Notice of availability; with the initial submission of an submitted date. correction. application to market the human drug 3. The date the application was product and continues until FDA grants approved: May 27, 2015. FDA has SUMMARY: The Food and Drug permission to market the drug product. verified the applicant’s claims that NDA Administration is correcting a notice Although only a portion of a regulatory 206940 was approved on May 27, 2015. entitled ‘‘Hazard Analysis and Risk- VerDate Sep<11>2014 18:08 Feb 02, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\05FEN1.SGM 05FEN1

Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices 5107 Based Preventive Controls for Food for 395–7285, or emailed to oira_ bearing or containing new animal drugs Animals; Draft Guidance for Industry; submission@omb.eop.gov. All under section 512(m)(4). Availability’’ that appeared in the comments should be identified with the Section 514.80 of our regulations (21 Federal Register of January 23, 2018. OMB control number 0910–0284. Also CFR 514.80) sets forth the recordkeeping The document announced the include the FDA docket number found and reporting requirements for availability of a draft guidance for in brackets in the heading of this applicants and nonapplicants of industry #245 entitled ‘‘Hazard Analysis document. approved NADAs and ANADAs. Section and Risk-Based Preventive Controls for FOR FURTHER INFORMATION CONTACT: Ila 510.301 of our regulations (21 CFR Food for Animals.’’ The document was S. Mizrachi, Office of Operations, Food 510.301) sets forth the recordkeeping published with the incorrect docket and Drug Administration, Three White and reporting requirements for licensed number. This document corrects that Flint North, 10A–12M, 11601 medicated feed manufacturing facilities. error. Landsdown St., North Bethesda, MD Recordkeeping and reporting FOR FURTHER INFORMATION CONTACT: Lisa 20852, 301–796–7726, PRAStaff@ requirements for applicants of approved Granger, Office of Policy and Planning, fda.hhs.gov. NADAs and ANADAs. Section 514.80 Food and Drug Administration, 10903 requires applicants to keep records of SUPPLEMENTARY INFORMATION: In and report to us data, studies, and other New Hampshire Ave., Bldg. 32, Rm. compliance with 44 U.S.C. 3507, FDA 3330, Silver Spring, MD 20993–0002, information concerning experience with has submitted the following proposed new animal drugs for each approved 301–796–9115. collection of information to OMB for SUPPLEMENTARY INFORMATION: In the NADA and ANADA. Following review and clearance. complaints from animal owners or Federal Register of Tuesday, January 23, 2018 (83 FR 3163), in FR Doc. 2018– Animal Drug Adverse Event Reporting veterinarians or following their own 01126, on page 3163, the following and Recordkeeping—21 U.S.C. 360b(l), detection of a problem, applicants are correction is made: 21 CFR 510.301, and 514.80 required to submit adverse event reports 1. On page 3163, in the first column, and product defect reports under OMB Control Number 0910–0284— § 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), in the header of the document, the Extension docket number is corrected to read and (b)(4)(iv)(A) on Form FDA 1932. ‘‘FDA–2018–D–0388’’. With regard to adverse events and Form FDA 1932a (the voluntary product/manufacturing defects reporting form) is used by veterinarians Dated: January 30, 2018. associated with approved new animal and the general public to submit adverse Leslie Kux, drugs, section 512(l) of the Federal event reports, product defects, and lack Associate Commissioner for Policy. Food, Drug, and Cosmetic Act (FD&C of effectiveness complaints directly to [FR Doc. 2018–02181 Filed 2–2–18; 8:45 am] Act) (21 U.S.C. 360b(l)) requires FDA. Form FDA 2301 is used by BILLING CODE 4164–01–P applicants with approved new animal applicants to submit the required drug applications (NADAs) and transmittal of periodic reports abbreviated new animal drug (§ 514.80(b)(4)); special drug experience DEPARTMENT OF HEALTH AND applications (ANADAs) to establish and reports (§ 514.80(b)(5)(i)); promotional HUMAN SERVICES maintain records and reports of data material for new animal drugs relating to experience with uses of such (§ 514.80(b)(5)(ii)); and distributor Food and Drug Administration drug, or with respect to animal feeds statements (§ 514.80(b)(5)(iii)). We [Docket No. FDA–2017–N–2428] bearing or containing such drug, to review the records and reports required facilitate a determination under section in § 514.80 and the voluntary reports to Agency Information Collection 512(e) as to whether there may be facilitate a determination under section Activities; Submission for Office of grounds for suspending or withdrawing 512(e) of the FD&C Act as to whether Management and Budget Review; approval of the NADA or ANADA under there may be grounds for suspending or Comment Request; Animal Drug section 512(e) or 512(m)(4). Sections withdrawing approval of the new Adverse Event Reporting and 571(e)(3) and 512(e)(2) of the FD&C Act animal drug. We have made minor Recordkeeping (21 U.S.C. 360ccc(e)(3) and 360b(e)(2)) editorial revisions to Form FDA 1932a require that applicants with to clarify how to report adverse drug AGENCY: Food and Drug Administration, conditionally approved new animal events associated with compounded HHS. drug applications (CNADAs) maintain products using that form. Submitters are ACTION: Notice. adequate records and make reports in already reporting adverse drug events SUMMARY: The Food and Drug accordance with a regulation or order associated with compounded products Administration (FDA or we) is issued under section 512(l). Finally, on Form FDA 1932a. The clarifications announcing that a proposed collection section 512(m)(5) of the FD&C Act include: the addition of a new question, of information has been submitted to the requires an applicant for a license to ‘‘Is this a compounded product?’’; the Office of Management and Budget manufacture animal feeds bearing or addition of a new field to allow the (OMB) for review and clearance under containing new animal drugs to submitter to provide product strength, the Paperwork Reduction Act of 1995. maintain adequate records and make ‘‘Strength of Active Ingredient(s)’’; reports ‘‘as the Secretary may by general modifying the title of the existing field DATES: Fax written comments on the regulation, or by order with respect to requesting the name of manufacturer, so collection of information by March 7, such application, prescribe on the basis that it reads, ‘‘Name of Manufacturer or sradovich on DSK3GMQ082PROD with NOTICES 2018. of a finding that such records and Compounding Pharmacy/Compounder ADDRESSES: To ensure that comments on reports are necessary in order to enable of Suspected Product’’; and a request for the information collection are received, the Secretary to determine’’ whether contact information for the OMB recommends that written there may be grounds for suspending or manufacturer or compounder. We comments be faxed to the Office of withdrawing approval of the new estimate that the revisions will not Information and Regulatory Affairs, animal drug under section 512(e) or a change the average amount of time OMB, Attn: FDA Desk Officer, Fax: 202– license to manufacture animal feeds necessary to complete the form. VerDate Sep<11>2014 18:08 Feb 02, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\05FEN1.SGM 05FEN1


Document Created: 2018-02-03 01:24:42
Document Modified: 2018-02-03 01:24:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability; correction.
ContactLisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.
FR Citation83 FR 5106 
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