Guidance for Industry: Considering Whether a Food and Drug Administration-Regulated Product Involves the Application of Nanotechnology; Availability, 36534-36535 [2014-15033]

Download as PDF 36534 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices processing your requests. See the section for electronic access to the guidance. 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: Ritu Nalubola, Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4236, Silver Spring, MD 20993–0002, 301–796–4830,email: Ritu.Nalubola@fda.hhs.gov. SUPPLEMENTARY INFORMATION: sentence to find the most current version of the guidance. SUPPLEMENTARY INFORMATION Dated: June 23, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–15031 Filed 6–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0530] Guidance for Industry: Considering Whether a Food and Drug Administration-Regulated Product Involves the Application of Nanotechnology; Availability AGENCY: I. Background Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled ‘‘Guidance for Industry: Considering Whether an FDARegulated Product Involves the Application of Nanotechnology.’’ This guidance explains FDA’s current thinking on determining whether FDAregulated products involve the application of nanotechnology. The guidance identifies two Points to Consider, which address both particle dimensions and dimension-dependent properties or phenomena. If either point applies to a given product, industry and FDA should consider whether evaluations of safety, effectiveness, public health impact, or regulatory status of that product have identified and adequately addressed any unique properties or behaviors of the product. These two Points to Consider are intended to provide an initial screening tool that can be broadly applied to all FDA-regulated products, with the understanding that these points are subject to change in the future as new information becomes available. DATES: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance entitled ‘‘Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology’’ to the Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in wreier-aviles on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:30 Jun 26, 2014 Jkt 232001 We are announcing the availability of a guidance entitled ‘‘Guidance for Industry: Considering Whether an FDARegulated Product Involves the Application of Nanotechnology.’’ This guidance is intended for manufacturers, suppliers, importers, and other stakeholders. It describes FDA’s current thinking on determining whether FDA-regulated products involve the application of nanotechnology. In the Federal Register of June 14, 2011 (76 FR 34715), we made available a draft guidance entitled ‘‘Draft Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology’’ and gave interested parties an opportunity to submit comments by August 15, 2011, for us to consider before beginning work on the final version of the guidance. We received several comments on the draft guidance and have modified the final guidance, where appropriate. The guidance announced in this notice finalizes the draft guidance dated June 2011. This guidance provides an overarching framework for FDA’s approach to the regulation of nanotechnology products. Based on our current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness, public health impact, or regulatory status of nanotechnology products should consider any unique properties and behaviors that the application of nanotechnology may impart. This guidance identifies two Points to Consider that should be applied when considering whether FDA-regulated products involve the application of nanotechnology. These Points address both particle dimensions and dimension-dependent properties or PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 phenomena. If either point applies to a given product, industry and FDA should consider whether the evaluations of safety, effectiveness, public health impact, or regulatory status of that product have identified and adequately addressed any unique properties or behaviors of the product. These two Points to Consider are intended to provide an initial screening tool that can be broadly applied to all FDA-regulated products, with the understanding that these points are subject to change in the future as new information becomes available. In particular, FDA may further refine these points, either as applicable broadly to all FDA-regulated products or as applicable to particular products or classes of products, as justified by scientific information. We will consider future revisions to our approach, including developing regulatory definitions relevant to nanotechnology, as warranted and in keeping with evolving scientific understanding. FDA may also provide additional guidance, including productspecific guidance documents, to address issues such as the regulatory status, safety, effectiveness, performance, quality, or public health impact of nanotechnology products. We urge industry to consult early with FDA so that any questions related to the regulatory status, safety, effectiveness, or public health impact of products that involve the application of nanotechnology can be appropriately and adequately addressed. II. Significance of Guidance This level 1 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 this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of applicable statutes and regulations. III. Comments Interested persons may submit either electronic comments regarding the guidance to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. E:\FR\FM\27JNN1.SGM 27JNN1 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/ScienceResearch/ SpecialTopics/Nanotechnology/ default.htm or https:// www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: June 23, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–15033 Filed 6–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–E–0038] Determination of Regulatory Review Period for Purposes of Patent Extension; VICTRELIS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for VICTRELIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions (two copies are required) and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993–0002, 301– 796–7900. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) wreier-aviles on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:30 Jun 26, 2014 Jkt 232001 generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product VICTRELIS (boceprevir). VICTRELIS is indicated for treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. Subsequent to this approval, the USPTO received a patent term restoration application for VICTRELIS (U.S. Patent No. RE43298) from Schering Corporation and Dendreon Corporation, and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 9, 2012, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VICTRELIS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for VICTRELIS is 2,160 days. Of this time, 1,980 days occurred during the testing phase of the regulatory review period, while 180 days occurred during the PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 36535 approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: June 15, 2005. The applicant claims June 18, 2005, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was June 15, 2005, which was the date the applicant was informed that they could proceed with their proposed clinical investigations. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 15, 2010. FDA has verified the applicant’s claim that the new drug application (NDA) for VICTRELIS (NDA 202–258) was submitted on November 15, 2010. 3. The date the application was approved: May 13, 2011. FDA has verified the applicant’s claim that NDA 202–258 was approved on May 13, 2011. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,032 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by August 26, 2014. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 24, 2014. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. 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. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36534-36535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15033]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0530]


Guidance for Industry: Considering Whether a Food and Drug 
Administration-Regulated Product Involves the Application of 
Nanotechnology; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance entitled ``Guidance for Industry: 
Considering Whether an FDA-Regulated Product Involves the Application 
of Nanotechnology.'' This guidance explains FDA's current thinking on 
determining whether FDA-regulated products involve the application of 
nanotechnology. The guidance identifies two Points to Consider, which 
address both particle dimensions and dimension-dependent properties or 
phenomena. If either point applies to a given product, industry and FDA 
should consider whether evaluations of safety, effectiveness, public 
health impact, or regulatory status of that product have identified and 
adequately addressed any unique properties or behaviors of the product. 
These two Points to Consider are intended to provide an initial 
screening tool that can be broadly applied to all FDA-regulated 
products, with the understanding that these points are subject to 
change in the future as new information becomes available.

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

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Guidance for Industry: Considering Whether an FDA-Regulated 
Product Involves the Application of Nanotechnology'' to the Office of 
Policy, Office of the Commissioner, Food and Drug Administration, 10903 
New Hampshire Ave., 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 guidance.
    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: Ritu Nalubola, Office of Policy, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, rm. 4236, Silver Spring, MD 20993-0002, 301-
796-4830,email: Ritu.Nalubola@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance entitled 
``Guidance for Industry: Considering Whether an FDA-Regulated Product 
Involves the Application of Nanotechnology.''
    This guidance is intended for manufacturers, suppliers, importers, 
and other stakeholders. It describes FDA's current thinking on 
determining whether FDA-regulated products involve the application of 
nanotechnology. In the Federal Register of June 14, 2011 (76 FR 34715), 
we made available a draft guidance entitled ``Draft Guidance for 
Industry: Considering Whether an FDA-Regulated Product Involves the 
Application of Nanotechnology'' and gave interested parties an 
opportunity to submit comments by August 15, 2011, for us to consider 
before beginning work on the final version of the guidance. We received 
several comments on the draft guidance and have modified the final 
guidance, where appropriate. The guidance announced in this notice 
finalizes the draft guidance dated June 2011.
    This guidance provides an overarching framework for FDA's approach 
to the regulation of nanotechnology products. Based on our current 
scientific and technical understanding of nanomaterials and their 
characteristics, FDA believes that evaluations of safety, 
effectiveness, public health impact, or regulatory status of 
nanotechnology products should consider any unique properties and 
behaviors that the application of nanotechnology may impart. This 
guidance identifies two Points to Consider that should be applied when 
considering whether FDA-regulated products involve the application of 
nanotechnology. These Points address both particle dimensions and 
dimension-dependent properties or phenomena. If either point applies to 
a given product, industry and FDA should consider whether the 
evaluations of safety, effectiveness, public health impact, or 
regulatory status of that product have identified and adequately 
addressed any unique properties or behaviors of the product.
    These two Points to Consider are intended to provide an initial 
screening tool that can be broadly applied to all FDA-regulated 
products, with the understanding that these points are subject to 
change in the future as new information becomes available. In 
particular, FDA may further refine these points, either as applicable 
broadly to all FDA-regulated products or as applicable to particular 
products or classes of products, as justified by scientific 
information.
    We will consider future revisions to our approach, including 
developing regulatory definitions relevant to nanotechnology, as 
warranted and in keeping with evolving scientific understanding. FDA 
may also provide additional guidance, including product-specific 
guidance documents, to address issues such as the regulatory status, 
safety, effectiveness, performance, quality, or public health impact of 
nanotechnology products.
    We urge industry to consult early with FDA so that any questions 
related to the regulatory status, safety, effectiveness, or public 
health impact of products that involve the application of 
nanotechnology can be appropriately and adequately addressed.

II. Significance of Guidance

    This level 1 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 this topic. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. You may use an alternative approach if such approach 
satisfies the requirements of applicable statutes and regulations.

III. Comments

    Interested persons may submit either electronic comments regarding 
the guidance to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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.

[[Page 36535]]

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm or https://www.regulations.gov. Use the FDA Web site listed 
in the previous sentence to find the most current version of the 
guidance.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15033 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.