Patent term restoration (21 CFR 60.1-60.46)

379 Food and Drug Administration, HHS Pt. 60 (b) The Food and Drug Administra tion may refuse to consider any par ticular nonclinical laboratory study in support of an application for a research or marketing permit, if it finds that the study was not conducted in accord ance with the good laboratory practice regulations set forth in this part, with out disqualifying the testing facility that conducted the study or under taking other regulatory action. § 58.217 Suspension or termination of a testing facility by a sponsor. Termination of a testing facility by a sponsor is independent of, and neither in lieu of nor a precondition to, pro ceedings or actions authorized by this subpart. If a sponsor terminates or sus pends a testing facility from further participation in a nonclinical labora tory study that is being conducted as part of any application for a research or marketing permit that has been sub mitted to any Center of the Food and Drug Administration (whether ap proved or not), it shall notify that Cen ter in writing within 15 working days of the action; the notice shall include a statement of the reasons for such ac tion. Suspension or termination of a testing facility by a sponsor does not relieve it of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration. [43 FR 60013, Dec. 22, 1978, as amended at 50 FR 8995, Mar. 6, 1985] § 58.219 Reinstatement of a disquali fied testing facility. A testing facility that has been dis qualified may be reinstated as an ac ceptable source of nonclinical labora tory studies to be submitted to the Food and Drug Administration if the Commissioner determines, upon an evaluation of the submission of the testing facility, that the facility can adequately assure that it will conduct future nonclinical laboratory studies in compliance with the good laboratory practice regulations set forth in this part and, if any studies are currently being conducted, that the quality and integrity of such studies have not been seriously compromised. A disqualified testing facility that wishes to be so re instated shall present in writing to the Commissioner reasons why it believes it should be reinstated and a detailed description of the corrective actions it has taken or intends to take to assure that the acts or omissions which led to its disqualification will not recur. The Commissioner may condition rein statement upon the testing facility being found in compliance with the good laboratory practice regulations upon an inspection. If a testing facility is reinstated, the Commissioner shall so notify the testing facility and all or ganizations and persons who were noti fied, under § 58.213 of the disqualifica tion of the testing facility. A deter mination that a testing facility has been reinstated is disclosable to the public under part 20 of this chapter. PART 60—PATENT TERM RESTORATION Subpart A—General Provisions Sec. 60.1 Scope. 60.2 Purpose. 60.3 Definitions. Subpart B—Eligibility Assistance 60.10 FDA assistance on eligibility. Subpart C—Regulatory Review Period Determinations 60.20 FDA action on regulatory review pe riod determinations. 60.22 Regulatory review period determina tions. 60.24 Revision of regulatory review period determinations. 60.26 Final action on regulatory review pe riod determinations. 60.28 Time frame for determining regu latory review periods. Subpart D—Due Diligence Petitions 60.30 Filing, format, and content of peti tions. 60.32 Applicant response to petition. 60.34 FDA action on petitions. 60.36 Standard of due diligence. Subpart E—Due Diligence Hearings 60.40 Request for hearing. 60.42 Notice of hearing. 60.44 Hearing procedures. 60.46 Administrative decision. AUTHORITY: 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00389 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 380 21 CFR Ch. I (4–1–16 Edition) § 60.1 SOURCE: 53 FR 7305, Mar. 7, 1988, unless oth erwise noted. EDITORIAL NOTE: Nomenclature changes to part 60 appear at 68 FR 24879, May 9, 2003. Subpart A—General Provisions § 60.1 Scope. (a) This part sets forth procedures and requirements for the Food and Drug Administration’s review of appli cations for the extension of the term of certain patents under 35 U.S.C. 156. Patent term restoration is available for certain patents related to drug products (as defined in 35 U.S.C. 156(f)(2)), and to medical devices, food additives, or color additives subject to regulation under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act. Food and Drug Ad ministration actions in this area in clude: (1) Assisting the United States Pat ent and Trademark Office in deter mining eligibility for patent term res toration; (2) Determining the length of a prod uct’s regulatory review period; (3) If petitioned, reviewing and ruling on due diligence challenges to the Food and Drug Administration’s regulatory review period determinations; and (4) Conducting hearings to review ini tial Food and Drug Administration findings on due diligence challenges. (b) References in this part to the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992] § 60.2 Purpose. (a) The purpose of this part is to es tablish a thorough yet efficient process for the Food and Drug Administration review of patent term restoration ap plications. To achieve this purpose, the regulations are intended to: (1) Facilitate determinations of pat ent term restoration eligibility and regulatory review period length, and (2) Ensure that parties interested in due diligence challenges will have an opportunity to participate in that process, including informal hearings. (b) The regulations are intended to complement those promulgated by the United States Patent and Trademark Office to implement those parts of the law which are under that agency’s ju risdiction. These regulations shall be construed in light of these objectives. § 60.3 Definitions. (a) The definitions contained in 35 U.S.C. 156 apply to those terms when used in this part. (b) The following definitions of terms apply to this part: (1) The term Act means the Federal Food, Drug, and Cosmetic Act (secs. 201–901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301–392)). (2) Active ingredient means any com ponent that is intended to furnish pharmacological activity or other di rect effect in the diagnosis, cure, miti gation, treatment, or prevention of dis ease, or to affect the structure or any function of the body of man or of ani mals. The term includes those compo nents that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (3) Applicant means any person who submits an application or an amend ment or supplement to an application under 35 U.S.C. 156 seeking patent term restoration. (4) Application means an application for patent term restoration submitted under 35 U.S.C. 156. (5) Clinical investigation or study means any experiment that involves a test article and one or more subjects and that is either subject to require ments for prior submission to the Food and Drug Administration under section 505(i), 512(j), or 520(g) of the Federal Food, Drug, and Cosmetic Act, or is not subject to the requirements for prior submission to FDA under those sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, FDA as part of an application for a research or mar keting permit. The term does not in clude experiments that are subject to the provisions of part 58 regarding non clinical laboratory studies. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00390 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 381 Food and Drug Administration, HHS § 60.10 (6) Color additive means any sub stance that meets the definition in sec tion 201(t) of the Act and which is sub ject to premarketing approval under section 721 of the Act. (7) Due diligence petition means a peti tion submitted under § 60.30(a). (8) FDA means the Food and Drug Administration. (9) Food additive means any substance that meets the definition in section 201(s) of the Act and which is subject to premarketing approval under section 409 of the Act. (10) Human drug product means the active ingredient of a new drug or human biologic product (as those terms are used in the Act and the Public Health Service Act), including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient. (11) Marketing applicant means any person who submits an application for premarketing approval by FDA under: (i) Section 505(b) of the Act or section 351 of the Public Health Service Act (human drug products); (ii) Section 515 of the Act (medical devices); (iii) Section 409 or 721 of the Act (food and color additives); or (iv) Section 512 of the Act (animal drug products). (12) Marketing application means an application for: (i) Human drug products submitted under section 505(b) of the Act or sec tion 351 of the Public Health Service Act; (ii) Medical devices submitted under section 515 of the Act; (iii) Food and color additives sub mitted under section 409 or 721 of the Act; or (iv) Animal drug products submitted under section 512 of the Act. (13) Medical device means any article that meets the definition in section 201(h) of the Act and which is subject to premarketing approval under sec tion 515 of the Act. (14) Product means a human drug product, animal drug product, medical device, food additive, or color additive, as those terms are defined in this sec tion. (15) PTO means the United States Patent and Trademark Office. (16) Animal drug product means the active ingredient of a new animal drug (as that term is used in the Act) that is not primarily manufactured using re combinant deoxyribonucleic acid (DNA), recombinant ribonucleic acid (RNA), hybridoma technology, or other processes involving site-specific ge netic manipulation techniques, includ ing any salt or ester of the active in gredient, as a single entity or in com bination with another active ingre dient. [53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992; 64 FR 399, Jan. 5, 1999] Subpart B—Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows: (1) Verifying whether the product was subject to a regulatory review pe riod before its commercial marketing or use; (2) For human drug products, food ad ditives, color additives, and medical devices, determining whether the per mission for commercial marketing or use of the product after the regulatory review period is the first permitted commercial marketing or use of the product either: (i) Under the provision of law under which the regulatory review period oc curred; or (ii) Under the process claimed in the patent when the patent claims a meth od of manufacturing the product that primarily uses recombinant deoxyribonucleic acid (DNA) tech nology in the manufacture of the prod uct; (3) For animal drug products, deter mining whether the permission for commercial marketing or use of the product after the regulatory review pe riod: (i) Is the first permitted commercial marketing or use of the product; or (ii) Is the first permitted commercial marketing or use of the product for ad ministration to a food-producing ani mal, whichever is applicable, under the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00391 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 382 21 CFR Ch. I (4–1–16 Edition) § 60.20 provision of law under which the regu latory review period occurred; (4) Informing the U.S. Patent and Trademark Office whether the patent term restoration application was sub mitted within 60 days after the product was approved for marketing or use, or, if the product is an animal drug ap proved for use in a food-producing ani mal, verifying whether the application was filed within 60 days of the first ap proval for marketing or use in a food producing animal; and (5) Providing the U.S. Patent and Trademark Office with any other infor mation relevant to the U.S. Patent and Trademark Office’s determination of whether a patent related to a product is eligible for patent term restoration. (b) FDA will notify the U.S. Patent and Trademark Office of its findings in writing, send a copy of this notifica tion to the applicant, and file a copy of the notification in the docket estab lished for the application in FDA’s Di vision of Dockets Management (HFA– 305), 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. [57 FR 56261, Nov. 27, 1992] Subpart C—Regulatory Review Period Determinations § 60.20 FDA action on regulatory re view period determinations. (a) FDA will consult its records and experts to verify the dates contained in the application and to determine the length of the product’s regulatory re view period under § 60.22. The applica tion shall contain information relevant to the determination of the regulatory review period as stated in the ‘‘Guide lines for Extension of Patent Term Under 35 U.S.C. 156’’ published on Octo ber 9, 1984, in PTO’s Official Gazette and as required by 37 CFR chapter I. (b) After determining the length of the regulatory review period, FDA will notify PTO in writing of its determina tion, send a copy of this determination to the applicant, and file a copy of the determination in the docket estab lished for the application in FDA’s Di vision of Dockets Management (HFA– 305), 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. (c) FDA will also publish the regu latory review period determination in the FEDERAL REGISTER. The notice will include the following: (1) The name of the applicant; (2) The trade name and generic name (if applicable) of the product; (3) The number of the patent for which an extension of the term is sought; (4) The approved indications or uses for the product; (5) An explanation of any discrep ancies between the dates in the appli cation and FDA records; (6) Where appropriate, an explanation that FDA has no record in which to re view the date(s) contained in the appli cation; and (7) The regulatory review period de termination, including a statement of the length of the testing and approval phases and the dates used in calcu lating each phase. [53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994] § 60.22 Regulatory review period de terminations. In determining a product’s regu latory review period, which consists of the sum of the lengths of a testing phase and an approval phase, FDA will review the information in each applica tion using the following definitions of the testing phase and the approval phase for that class of products. (a) For human drugs: (1) The testing phase begins on the date an exemption under section 505(i) of the Act becomes effective (or the date an exemption under former sec tion 507(d) of the Act became effective) for the approved human drug product and ends on the date a marketing ap plication under section 351 of the Pub lic Health Service Act or section 505 of the act is initially submitted to FDA (or was initially submitted to FDA under former section 507 of the Act), and (2) The approval phase begins on the date a marketing application under section 351 of the Public Health Service Act or section 505(b) of the Act is ini tially submitted to FDA (or was ini tially submitted under former section 507 of the Act) and ends on the date the application is approved. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00392 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 383 Food and Drug Administration, HHS § 60.22 (b) For food and color additives: (1) The testing phase begins on the date a major health or environmental effects test is begun and ends on the date a petition relying on the test and requesting the issuance of a regulation for use of the additive under section 409 or 721 of the Act is initially submitted to FDA. (2) The approval phase begins on the date a petition requesting the issuance of a regulation for use of the additive under section 409 or 721 of the Act is initially submitted to FDA and ends upon whichever of the following occurs last: (i) The regulation for the additive be comes effective; or (ii) Objections filed against the regu lation that result in a stay of effective ness are resolved and commercial mar keting is permitted; or (iii) Proceedings resulting from ob jections to the regulation, after com mercial marketing has been permitted and later stayed pending resolution of the proceedings, are finally resolved and commercial marketing is per mitted. (c) For medical devices: (1) The testing phase begins on the date a clinical investigation on humans is begun and ends on the date an appli cation for premarket approval of the device or a notice of completion of a product development protocol is ini tially submitted under section 515 of the Act. For purposes of this part, a clinical investigation is considered to begin on whichever of the following dates applies: (i) If an investigational device ex emption (IDE) under section 520(g) of the Act is required, the effective date of the exemption. (ii) If an IDE is not required, but in stitutional review board (IRB) approval under section 520(g)(3) of the Act is re quired, the IRB approval date. (iii) If neither an IDE nor IRB ap proval is required, the date on which the device is first used with human subjects as part of a clinical investiga tion to be filed with FDA to secure pre market approval of the device. (2) The approval phase either: (i) Begins on the date an application for premarket approval of the device is initially submitted under section 515 of the Act and ends on the date the appli cation is approved; or (ii) Begins on the date a notice of completion of a product development protocol is initially submitted under section 515 of the Act and ends on the date the protocol is declared to be com pleted. (d) For animal drugs: (1) The testing phase begins on the date a major health or environmental effects test is begun or the date on which the agency acknowledges the fil ing of a notice of claimed investiga tional exemption for a new animal drug, whichever is earlier, and ends on the date a marketing application under section 512 of the Act is initially sub mitted to FDA. (2) The approval phase begins on the date a marketing application under section 512 of the Act is initially sub mitted to FDA and ends on the date the application is approved. (e) For purposes of this section, a ‘‘major health or environmental effects test’’ may be any test which: (1) Is reasonably related to the eval uation of the product’s health or envi ronmental effects, or both: (2) Produces data necessary for mar keting approval; and (3) Is conducted over a period of no less than 6 months duration, excluding time required to analyze or evaluate test results. (f) For purposes of determining the regulatory review period for any prod uct, a marketing application, a notice of completion of a product develop ment protocol, or a petition is initially submitted on the date it contains suffi cient information to allow FDA to commence review of the application. A marketing application, a notice of completion of a product development protocol, or a petition is approved on the date FDA sends the applicant a let ter informing it of the approval or, by order declares a product development protocol to be completed, or, in the case of food and color additives, on the effective date of the final rule listing the additive for use as published in the FEDERAL REGISTER or, in the case of a new animal drug in a Category II Type A medicated article, on the date of publication in the FEDERAL REGISTER of the notice of approval pursuant to VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00393 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 384 21 CFR Ch. I (4–1–16 Edition) § 60.24 section 512(i) of the Act. For purposes of this section, the regulatory review period for an animal drug shall mean either the regulatory review period re lating the drug’s approval for use in nonfood-producing animals or the regu latory review period relating to the drug’s approval for use in food-pro ducing animals, whichever is applica ble. [53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56262, Nov. 27, 1992; 64 FR 400, Jan. 5, 1999] § 60.24 Revision of regulatory review period determinations. (a) Any person may request a revi sion of the regulatory review period de termination within 60 days after its initial publication in the FEDERAL REGISTER. The request shall be sent to the Division of Dockets Management (HFA–305), Food and Drug Administra tion, 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. The request shall speci fy the following: (1) The type of action requested; (2) The identity of the product; (3) The identity of the applicant; (4) The FDA docket number; and (5) The basis for the request for revi sion, including any documentary evi dence. (b) Unless the applicant is the person requesting the revision, the applicant shall respond to the request within 15 days. In responding to the request, the applicant may submit information which is relevant to the events during the regulatory review period but which was not included in the original patent term restoration application. A request for a revision is not equivalent to a due diligence petition under § 60.30 or a re quest for a hearing under § 60.40. If no response is submitted, FDA will decide the matter on the basis of the informa tion in the patent term restoration ap plication, request for revision, and FDA records. (c) FDA shall apply the provisions of § 60.22 in considering the request for a revision of the regulatory review pe riod determination. lf FDA revises its prior determination, FDA will notify PTO of the revision, send a copy of this notification to the applicant, and pub lish the revision in the FEDERAL REG ISTER, including a statement giving the reasons for the revision. [53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 67 FR 9585, Mar. 4, 2002] § 60.26 Final action on regulatory re view period determinations. (a) FDA will consider a regulatory re view period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 60.30 unless FDA receives: (1) New information from PTO records, FDA records, or FDA centers that affects the regulatory review pe riod determination; (2) A request under § 60.24 for revision of the regulatory review period deter mination; (3) A due diligence petition filed under § 60.30; or (4) A request for a hearing filed under § 60.40. (b) FDA will notify PTO that the reg ulatory review period determination is final upon: (1) The expiration of the 180-day pe riod for filing a due diligence petition; or (2) If FDA has received a request for a revision, a due diligence petition, or a request for a hearing, upon resolution of the request for a revision, the peti tion, or the hearing, whichever is later. FDA will send a copy of the notifica tion to the applicant and file a copy of the notification in the docket estab lished for the application in FDA’s Di vision of Dockets Management (HFA– 305), 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. [53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994] § 60.28 Time frame for determining regulatory review periods. (a) FDA will determine the regu latory review period for a product within 30 days of the receipt of a writ ten request from PTO for such a deter mination and a copy of the patent term restoration application. (b) FDA may extend the 30-day period if: (1) A related FDA action that may af fect the regulatory review period deter mination is pending; or VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00394 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 385 Food and Drug Administration, HHS § 60.34 (2) PTO requests that FDA tempo rarily suspend the determination proc ess; or (3) PTO or FDA receives new infor mation about the product that war rants an extension of the time required for the determination of the regulatory review period. (c) This section does not apply to ap plications withdrawn by the applicant or applications that PTO determines are ineligible for patent term restora tion. Subpart D—Due Diligence Petitions § 60.30 Filing, format, and content of petitions. (a) Any person may file a petition with FDA, no later than 180 days after the publication of a regulatory review period determination under § 60.20, that challenges FDA’s determination by al leging that the applicant for patent term restoration did not act with due diligence in seeking FDA approval of the product during the regulatory re view period. (b) The petition shall be filed in ac cordance with § 10.20, under the docket number of the FEDERAL REGISTER no tice of the agency’s regulatory review period determination, and shall be in the format specified in § 10.30. The peti tion shall contain the information specified in § 10.30 and any additional information required by this subpart. If any provision of § 10.20 or § 10.30 is in consistent with any provision of this part, FDA will consider the petition in accordance with this part. (c) The petition shall claim that the applicant did not act with due dili gence during some part of the regu latory review period and shall set forth sufficient facts, including dates if pos sible, to merit an investigation by FDA of whether the applicant acted with due diligence. (d) The petition shall contain a cer tification that the petitioner has served a true and complete copy of the petition upon the applicant by certified or registered mail (return receipt re quested) or by personal delivery. [53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002] § 60.32 Applicant response to petition. (a) The applicant shall file with FDA a written response to the petition no later than 30 days after the applicant’s receipt of a copy of the petition. (b) The applicant’s response may present additional facts and cir cumstances to address the assertions in the petition, but shall be limited to the issue of whether the applicant acted with due diligence during the regu latory review period. The applicant’s response may include documents that were not in the original patent exten sion application. (c) If the applicant does not respond to the petition, FDA will decide the matter on the basis of the information submitted in the patent term restora tion application, due diligence peti tion, and FDA records. § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a petition filed under § 60.30(a), the agency will either deny the petition under paragraph (b) or (c) of this sec tion or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the FEDERAL REGISTER, notify PTO of the due diligence determination in writing, and send copies of the notice to PTO, the applicant, and the peti tioner. (b) FDA may deny a due diligence pe tition without considering the merits of the petition if: (1) The petition is not filed in accord ance with § 60.30; (2) The petition is not filed in accord ance with § 10.20; (3) The petition does not contain the information required by § 10.30; (4) The petition fails to contain infor mation or allegations upon which it may reasonably be determined that the applicant did not act with due dili gence during the applicable regulatory review period; or (5) The petition fails to allege a suffi cient total amount of time during which the applicant did not exercise due diligence such that, even if the pe tition were granted, the petition would VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00395 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 386 21 CFR Ch. I (4–1–16 Edition) § 60.36 not affect the maximum patent exten sion the applicant sought in the appli cation. § 60.36 Standard of due diligence. (a) In determining the due diligence of an applicant, FDA will examine the facts and circumstances of the appli cant’s actions during the regulatory re view period to determine whether the applicant exhibited that degree of at tention, continuous directed effort, and timeliness as may reasonably be ex pected from, and are ordinarily exer cised by, a person during a regulatory review period. FDA will take into con sideration all relevant factors, such as the amount of time between the ap proval of an investigational exemption or research permit and the commence ment of a clinical investigation and the amount of time required to conduct a clinical investigation. (b) For purposes of this part, the ac tions of the marketing applicant shall be imputed to the applicant for patent term restoration. The actions of an agent, attorney, contractor, employee, licensee, or predecessor in interest of the marketing applicant or applicant for patent term restoration shall be imputed to the applicant for patent term restoration. Subpart E—Due Diligence Hearings § 60.40 Request for hearing. (a) Any person may request, not later than 60 days after the publication under § 60.34(a) of FDA’s due diligence determination, that FDA conduct an informal hearing on the due diligence determination. (b) The request for a hearing under this section shall: (1) Be sent by mail, personal delivery, or any other mode of written commu nication to the Division of Dockets Management and filed under the rel evant product file; (2) Specify the facts and the action that are the subject of the hearing; (3) Provide the name and address of the person requesting the hearing; and (4) Certify that the requesting party has served a true and complete copy of the request upon the petitioner and the applicant by certified or registered mail (return receipt requested) or by personal delivery. (c) The request shall state whether the requesting party seeks a hearing within 30 days or 60 days of FDA’s re ceipt of the request. [53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002] § 60.42 Notice of hearing. Ten days before the hearing, FDA will notify the requesting party, the applicant, and the petitioner, orally or in writing, of the date, time, and loca tion of the hearing. The agency will provide the requesting party, the appli cant, and the petitioner with an oppor tunity to participate as a party in the hearing. § 60.44 Hearing procedures. The due diligence hearing shall be conducted in accordance with this part, supplemented by the nonconflicting procedures in part 16. During the due diligence hearing, the applicant and the petitioner shall enjoy all the rights and privileges accorded a person re questing a hearing under part 16. The standard of due diligence set forth in § 60.36 will apply in the due diligence hearing. The party requesting the due diligence hearing shall have the burden of proof at the hearing. § 60.46 Administrative decision. Within 30 days after the completion of the due diligence hearing, the Com missioner will affirm or revise the de termination made under § 60.34(a) and will publish the due diligence redeter mination in the FEDERAL REGISTER, no tify PTO of the redetermination, and send copies of the notice to PTO and to the requesting party, the applicant, and the petitioner. PART 70—COLOR ADDITIVES Subpart A—General Provisions Sec. 70.3 Definitions. 70.5 General restrictions on use of color ad ditives. 70.10 Color additives in standardized foods and new drugs. 70.11 Related substances. 70.19 Fees for listing. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00396 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B