81 FR 78500 - Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 216 (November 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78500-78507 | |
| FR Document | 2016-26912 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Rules and Regulations] [Pages 78500-78507] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26912] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 10 [Docket No. FDA-2011-N-0697] RIN 0910-AG26 Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is amending certain regulations relating to citizen petitions, petitions for stay of action (PSAs), and the submission of documents to the Agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which concern certain citizen petitions and PSAs that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA), 505(b)(2) application, or certain applications submitted under the Public Health Service Act (PHS Act). We are making these changes to implement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the Food and Drug Administration Safety and Innovation Act (FDASIA). DATES: This rule is effective January 9, 2017. ADDRESSES: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number (FDA-2011-N-0697) into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD, 20993-0002, 240- 402-0978. SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary I. Background II. Overview of the Final Rule, Including Significant Changes to the Proposed Rule A. Overview B. Significant Changes to the Proposed Rule III. Comments on the Proposed Rule and FDA Responses A. Introduction B. Scope of the Proposed Rule (Sec. 10.31) C. Certification and Verification Requirements D. Nonretroactivity of the Rule E. Additional Comments IV. Legal Authority V. Analysis of Environmental Impact VI. Economic Analysis of Impacts A. Introduction and Summary B. Summary of Final Regulatory Impacts Analysis VII. Paperwork Reduction Act of 1995 VIII. Federalism IX. References Executive Summary Purpose of the Rule This rule establishes new regulations implementing section 505(q) of the FD&C Act (21 U.S.C. 355(q)) as enacted by FDAAA (Pub. L. 110-85) and amended by FDASIA (Pub. L. 112-144). Section 505(q) of the FD&C Act governs the manner in which FDA handles certain citizen petitions and PSAs that ask the Agency to take any form of action related to an ANDA, a 505(b)(2) application, or an application submitted under section 351(k) of the PHS Act (351(k) application) (42 U.S.C. 262(k)). Section 505(q) of the FD&C Act specifies that FDA must not delay approval of a pending application because of any request to take any form of action relating to the application, unless the request is in writing and in a citizen petition or a PSA, and the Agency determines, upon reviewing the petition, that a delay is necessary to protect the public health. Section 505(q) of the FD&C Act also requires that all submitters of a petition (or PSA) include with their submission a verbatim certification statement specifying the date on which the information relied on in the petition first became known. Similarly, section 505(q) of the FD&C Act requires that the submitters of a supplement or a comment to a petition include with their submission a verbatim verification statement specifying the date on which the information relied on in their submission first became known. By enacting section 505(q) of the FD&C Act, Congress indicated a desire to ensure that petitions not be used to improperly delay approval of ANDAs, 505(b)(2) applications, or 351(k) applications. This rule clarifies the requirements of section 505(q) of the FD&C Act. Summary of the Major Provisions of the Rule This rule amends FDA's regulations on general administrative procedures in part 10 (21 CFR part 10). [[Page 78501]] In Sec. 10.31, paragraph (a) states that Sec. 10.31 applies to all citizen petitions and PSAs that request that the Agency take any action that could, if taken, delay approval of an ANDA, a 505(b)(2) application, or a 351(k) application (i.e., petitions and PSAs that are or may be subject to section 505(q) of the FD&C Act). Section 10.31(b) clarifies that the date of submission for petitions submitted under Sec. 10.31 is the date on which the petition is received by FDA's Division of Dockets Management. The rule also codifies the certification and verification requirements of section 505(q) of the FD&C Act. Section 10.31(c) clarifies that the Agency will consider a certification deficient if every word in the petitioner's certification does not match every word of the certification provided in section 505(q)(1)(H) of the FD&C Act. Likewise, Sec. 10.31(d) clarifies that the Agency will consider the verification deficient if every word in the petitioner's or commenter's verification does not match every word of the verification provided in section 505(q)(1)(I) of the FD&C Act. However, because we believe section 505(q)(1)(I) of the FD&C Act contains a technical error when it specifies the word ``petition'' in the last sentence of the verification, we will accept either the word ``petition'' or ``document'' in the last sentence of the petitioner's or commenter's verification. The rule also amends Sec. Sec. 10.30 and 10.35. Section 10.30(e)(5) states that FDA intends to respond to a petition subject to section 505(q) of the FD&C Act within 150 days after the date on which the petition is received. This amendment incorporates a statutory change enacted by FDASIA. In addition, Sec. 10.35(i) clarifies that a petitioner requesting a stay of action may supplement, amend, or withdraw a PSA, similar to the provision for citizen petitions in current Sec. 10.30(g). Finally, Sec. Sec. 10.30(e)(3) and 10.35(e) are amended to reflect that the Commissioner of Food and Drugs (the Commissioner) may dismiss a petition if changes in law, facts, or circumstances since the date on which the petition was submitted render the petition moot. Costs and Benefits We estimate one-time costs to industry from this rule at about $613,800. We estimate annual costs at about $1,700. These costs equate to an estimated total annualized cost of about $89,100 at a 7 percent discount rate over 10 years and about $73,700 at a 3 percent discount rate over 10 years. The total annualized costs include the administrative cost to review the rule ($87,400) plus the cost for the additional effort preparing certifications for petitions and verifications for both responses to petitions and supplements to petitions ($1,700). By providing additional clarity on the statutory requirements, we expect the rule will slightly reduce the number of deficient 505(q) petitions, leading to lower administrative costs for both industry and FDA. I. Background In the Federal Register of January 3, 2012 (77 FR 25), FDA issued a proposed rule to amend certain regulations relating to citizen petitions, PSAs, and the submission of documents to the Agency, to implement provisions of section 505(q) of the FD&C Act. Section 505(q) of the FD&C Act governs certain citizen petitions and PSAs (collectively referred to as petitions) that ask FDA to take any form of action that could, if taken, delay approval of a pending application submitted under section 505(b)(2) or (j) of the FD&C Act or a pending application for licensure of a biological product as a biosimilar or interchangeable product that is submitted under section 351(k) of the PHS Act. An application submitted under section 505(b)(2) of the FD&C Act is a type of new drug application (NDA) described in that subsection and is referred to in this document as a ``505(b)(2) application.'' An application submitted under section 505(j) of the FD&C Act is an ANDA seeking approval for a generic drug product. An application submitted under section 351(k) of the PHS Act is referred to in this document as a ``351(k) application.'' Over the years, FDA has received numerous petitions asking the Agency not to approve a particular ANDA or 505(b)(2) application (or classes of these applications concerning a particular drug product or active ingredient) unless certain criteria set forth in the petition are met. In many cases, the petitions have raised scientific and/or legal issues relating to the standards for approval of an application. Examples include petitions suggesting a particular method for demonstrating the bioequivalence of a proposed generic product to the reference listed drug (RLD) and petitions maintaining that a proposed generic product does not contain the same active ingredient as the RLD. When submitted early, such as when we are making decisions about the bioequivalence requirements for a generic drug product or before we have received the first ANDA, 505(b)(2) application, or 351(k) application for a drug or biological product, a petition may contain information that can contribute towards our evaluation of an application. However, when petitions are submitted late in the review process for challenged applications and do not raise valid scientific and/or legal issues, they may have the effect of improperly delaying the approval of an application. By enacting section 505(q) of the FD&C Act, Congress indicated a desire to ensure that petitions not be used to improperly delay approval of ANDAs, 505(b)(2) applications, or 351(k) applications. Scope of section 505(q) of the FD&C Act: FDAAA was enacted on September 27, 2007. Section 914 of Title IX of FDAAA added section 505(q) to the FD&C Act. Section 505(q) of the FD&C Act was subsequently amended by FDASIA on July 9, 2012. Section 505(q)(1)(A) of the FD&C Act specifies that FDA must not delay approval of a pending ANDA, a 505(b)(2) application, or a 351(k) application because of any request to take any form of action relating to the application, unless the request is in writing and in a citizen petition submitted under Sec. 10.30 or a PSA submitted under Sec. 10.35, and the Agency determines, upon reviewing the petition, that a delay is necessary to protect the public health. In section 505(q)(5) of the FD&C Act the term application is defined as an application submitted under section 505(b)(2) or 505(j) of the FD&C Act or 351(k) of the PHS Act and the term petition is defined as a request defined in section 505(q)(1)(A)(i). Section 505(q)(1)(B) of the FD&C Act states in this context that if FDA determines that a delay of approval of an ANDA, a 505(b)(2) application, or a 351(k) application is necessary to protect the public health, FDA is required to provide to the applicant not later than 30 days after making the determination (1) notification that the determination has been made; (2) if applicable, any clarification or additional data that the applicant should submit to the petition docket to allow FDA to review the petition promptly; and (3) a brief summary of the specific substantive issues raised in the petition that form the basis of FDA's determination. At FDA's discretion, the information is to be conveyed either in writing or in a meeting with the applicant. The information conveyed in the notification is to be considered part of the application and is subject to the disclosure requirements applicable to information in the application. Section 505(q)(1)(F) of the FD&C Act governs the timeframe for final Agency action on a petition. Under this provision, FDA must take final Agency action on a petition not later than 150 [[Page 78502]] days after the date on which the petition is submitted. The 150-day period is not to be extended for any reason, including any determination made under section 505(q)(1)(A) of the FD&C Act regarding delay of approval of an application (i.e., that delay is necessary to protect the public health), the submission of comments or supplemental information, or the consent of the petitioner. In addition, FDA may deny a petition at any point if it determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues (section 505(q)(1)(E) of the FD&C Act). Section 505(q) of the FD&C Act also includes certification and verification requirements for certain documents. Under section 505(q)(1)(H) of the FD&C Act, FDA may not consider a petition for review unless the petition is in writing and is signed and contains a certification that is specified in that section. Section 505(q)(1)(H) of the FD&C Act sets forth the exact words to be used in the certification. In addition, FDA may not accept for review any supplemental information or comments on a petition unless the submission is in writing and is signed and contains a specific verification. Section 505(q)(1)(I) of the FD&C Act sets forth the exact words to be used in the verification. Section 505(q)(2) of the FD&C Act governs judicial review of final Agency action on a petition subject to section 505(q). Under section 505(q)(2)(A) of the FD&C Act, FDA will be considered to have taken final Agency action on a petition if FDA makes a final decision within the meaning of Sec. 10.45(d) during the 150-day period, or the 150-day period expires without FDA having made a final decision. Under section 505(q)(2)(B) of the FD&C Act, if a civil action is filed against the Secretary with respect to any issues raised in the petition before final Agency action, a court shall dismiss the action without prejudice for failure to exhaust administrative remedies. Section 505(q)(2) of the FD&C Act, however, does not apply to a petition containing requests relating to a 351(k) application. II. Overview of the Final Rule, Including Significant Changes to the Proposed Rule A. Overview In this rulemaking, the Agency finalizes the provisions outlined in the January 2012 proposed rule. In addition, the final rule incorporates changes enacted by FDASIA and responds to comments made to the proposed rule. FDA also is making editorial and organizational changes to clarify provisions. The final rule amends part 10 of FDA regulations on general administrative procedures. The amendment adds Sec. 10.31, which includes the following provisions:Section10.31(a) states that Sec. 10.31 will encompass all citizen petitions and PSAs that request that the Agency take any action that could, if taken, delay approval of an ANDA, a 505(b)(2) application, or a 351(k) application (i.e., petitions and PSAs that are or may be subject to section 505(q) of the FD&C Act). Section 10.31(b) clarifies the date of submission for petitions submitted under Sec. 10.31. Section 10.31(c) and (d) codify the certification and verification requirements of section 505(q)(1)(H) and (I) of the FD&C Act. Section 10.31(c) clarifies that the Agency will consider a certification deficient if every word in the petitioner's certification does not match every word of the certification provided in section 505(q)(1)(H) of the FD&C Act. Likewise, Sec. 10.31(d) clarifies that the Agency will consider the verification deficient if every word in the petitioner's or commenter's verification does not match every word of the verification provided in section 505(q)(1)(I) of the FD&C Act. As discussed in section II.B.4 of the preamble to the proposed rule, we are making one minor editorial change to the language of the verification set out in the statute. We are changing ``I verify under penalty of perjury that the foregoing is true and correct as of the date of this petition'' to ``I verify under penalty of perjury that the foregoing is true and correct as of the date of this document'' (emphasis added). Because the statute specifies the word ``petition'', we will accept either ``petition'' or ``document'' in the last sentence of the verification. In addition, section 505(q) of the FD&C Act requires both the certification and verification to be signed and executed under penalty of perjury. FDA interprets the signature provision to require a handwritten or electronic signature by the person whose name appears as the signatory to the petition, supplement, or comment. If the certification or verification is signed by another person with the notation ``for,'' signature/[initials], ``on behalf of,'' or with similar notation that indicates one person signed for another, we will consider the certification or verification to be deficient and will not consider the petition for review. The final rule amends Sec. Sec. 10.20, 10.30, and 10.35 as follows: Adds Sec. 10.30(e)(5) to incorporate a statutory change enacted by FDASIA. New Sec. 10.30(e)(5) states that FDA intends to respond to a petition subject to section 505(q) of the FD&C Act within 150 days after the date on which the petition is received. Revises Sec. 10.30(e)(2) to conform with the addition of Sec. 10.30(e)(5). Makes minor revisions to Sec. Sec. 10.20 and 10.30 to conform to the addition of Sec. 10.31. With respect to Sec. 10.35, administrative stay of action, makes revisions to conform with the implementation of section 505(q) of the FD&C Act. The final rule also adds new Sec. 10.35(i) to clarify that a petitioner requesting a stay of action may supplement, amend, or withdraw a PSA, similar to the provision for citizen petitions in current Sec. 10.30(g). In addition to implementing the provisions in section 505(q) of the FD&C Act, the final rule makes minor technical changes by revising Sec. Sec. 10.30(e)(3) and 10.35(e) to allow the Commissioner to dismiss a petition if changes in law, facts, or circumstances since the date on which the petition was submitted render the petition moot. B. Significant Changes to the Proposed Rule The final rule reflects revisions to the proposed rule in response to the enactment of FDASIA. Section 1135 of FDASIA amended section 505(q) of the FD&C Act in several ways. First, it shortened from 180 days to 150 days FDA's deadline for responding to petitions subject to section 505(q) of the FD&C Act. Second, it expanded the scope of section 505(q) of the FD&C Act to include certain petitions related to 351(k) applications. Lastly, FDASIA also added section 505(q)(4)(B) of the FD&C Act, which excludes such petitions from section 505(q)(2). Accordingly, the final rule includes the following changes to the proposed rule: Adds Sec. 10.30(e)(5) and revises Sec. 10.30(e)(2) to reflect FDA's 150-day deadline for responding to petitions subject to section 505(q) of the FD&C Act. Revises Sec. 10.31(a)(1) to reflect the applicability of section 505(q) of the FD&C Act to 351(k) applications. These changes conform the final rule to reflect amendments to section 505(q) of the FD&C Act enacted by FDASIA that became law after publication of the proposed rule. [[Page 78503]] III. Comments on the Proposed Rule and FDA Responses A. Introduction We received one submission containing several comments from the Pharmaceutical Research and Manufacturers of America (PhRMA). These comments primarily focused on the scope of proposed Sec. 10.31 and the certification and verification requirements. PhRMA also raised several issues we deemed outside the scope of the proposed rule. In the discussion that follows, we address the comments. We describe and respond to the comments in sections III.B through III.E. We have numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received. B. Scope of the Proposed Rule (Sec. 10.31) (Comment 1) We received a comment from PhRMA concerning the scope of the rule. PhRMA stated that, in some instances, the rule would require unnecessary certifications for petitions outside the scope of section 505(q) of the FD&C Act that could cause confusion among petitioners, commentators, and the courts regarding which rules to apply to any given petition. PhRMA claimed the proposed rule could compromise a petitioner's fundamental right to know which statutory requirements and timelines FDA will apply to the petition. Accordingly, PhRMA requested that FDA revise the proposed rule to limit the rule's application to cases in which there is evidence that a relevant ANDA or 505(b)(2) application is pending before FDA. (Response 1) We decline to make this revision. Normally, the existence of a pending application is not made public by FDA. (See e.g., 21 CFR 314.430.) To prevent uncertainty as to when a certification or verification is required and to protect against the unintended release of information acknowledging the existence of an ANDA, a 505(b)(2) application, or a 351(k) application, we are making Sec. 10.31 apply to all petitions that request an action that could delay the approval of an ANDA, a 505(b)(2) application, or a 351(k) application, regardless of whether an application subject to the petition's requested action is pending at the time the petition is submitted. Otherwise, if petitioners were to omit the certification statement and wait for FDA to inform them that the certification is required (because of the existence of a pending application), the filing of petitions could become a way for individuals to uncover the existence of certain pending applications. Neither FDAAA nor FDASIA suggest such an outcome. Moreover, rather than causing confusion, as PhRMA suggests, we believe that requiring certifications and verifications for all applicable petitions would remove any uncertainty as to whether a petitioner should submit or not submit a certification or verification. If there is no related ANDA, 505(b)(2) application, or 351(k) application pending at the time the petition is submitted, then the requirements of Sec. 10.31 will apply to the petition, but we will not consider the provisions of section 505(q) of the FD&C Act to apply to the petition. C. Certification and Verification Requirements (Comment 2) PhRMA expressed specific concerns regarding the certification and verification requirements of the rule. First, PhRMA requested that the discretionary language found in the preamble to the proposed rule, i.e., ``[t]he failure to provide any information relied upon (and the date) in the certification or verification may result in the failure of FDA to consider that information . . . .'', be clarified to prevent confusion over how FDA intends to interpret and implement the certification and verification requirements. Second, PhRMA questioned FDA's assertion that a failure to certify or verify a ``became known'' date would foreclose a petitioner from relying on that information when seeking judicial review. Accordingly, PhRMA requested that FDA: (1) Revise the proposed rule and provide additional explanation and examples to clarify what types of information petitioners must provide ``became known'' dates for and (2) ``provide support for, modify, or expressly withdraw'' the preamble statement concerning judicial review. (Response 2) We recognize that a petition, supplement, or comment could be based on more than one type of information or multiple pieces of information. Section 505(q) of the FD&C Act requires that the petitioner provide in the certification the date on or about which information first became known to the petitioner. We interpret section 505(q) of the FD&C Act to require an on or about date for each piece of information that is relied upon in the petition. Section II.B.7 of the preamble to the proposed rule provides an example illustrating how a petition may list different types of information. A petition, supplement, or comment will meet the certification/verification requirement if it contains a date followed by a short description of the information. This requirement is essential to carrying out the legislative intent of Congress and does not impose an unreasonable burden on petitioners. Because of the fact-based nature of a petition, it is impracticable for FDA to specifically define or categorize all types of information that may be relied upon by a petitioner. A petitioner or commenter can, however, reasonably be expected to identify the main categories of information on which the petition, supplement, or comment relies and to provide dates for such categories. Indeed, this interpretation of the certification has worked well to date. The failure to certify or verify a ``became known'' date for any item of information contained in a petition would preclude the petitioner from relying on that information when seeking judicial review since section 505(q)(1)(H) and (I) of the FD&C Act requires that FDA not consider and/or accept for review any petition or information that fails to meet the certification and verification requirements. D. Nonretroactivity of the Rule (Comment 3) PhRMA expressed concern that the rule could be read as retroactively imposing requirements on petitions filed after September 26, 2007, but before the effective date of the final rule. Based on its concern, PhRMA requested that FDA revise the rule to clarify that Sec. 10.31 will not apply to any petition that was pending at FDA before the final rule's effective date, to any supplement to such a petition, or to any comments on such a petition. (Response 3) FDA's guidance for industry ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act'' (Ref. 1), describes FDA's current thinking on the applicability of section 505(q) to petitions submitted after September 27, 2007. As that guidance notes, section 505(q) of the FD&C Act applies to all petitions that are submitted on or after September 27, 2007 (or July 9, 2012, if the subject matter of the petition relates to the approval of a 351(k) application). To the extent the final rule imposes any additional requirements, those requirements will apply only to those petitions submitted on or after the effective date of the final rule. E. Additional Comments (Comment 4) PhRMA requested that FDA include or otherwise establish a [[Page 78504]] mechanism for notifying a petitioner if the Agency determines that a delay of approval of an ANDA or 505(b)(2) application is not necessary to protect the public health. (Response 4) We decline to implement such a mechanism for notifying petitioners. As PhRMA pointed out, section 505(q) of the FD&C Act does not require such a notification. The only notification provision in section 505(q) of the FD&C Act is found in section 505(q)(1)(B), which requires FDA to inform an ANDA applicant, a section 505(b)(2) applicant, or a 351(k) applicant that a delay in approval is necessary to protect the public health. Moreover, such a notification mechanism would be burdensome for the Agency and could inadvertently inform the public of pending ANDAs, 505(b)(2) applications, or 351(k) applications. (Comment 5) PhRMA requested that FDA issue a regulation establishing (or clarifying) the administrative consequence of a decision to approve an ANDA or a 505(b)(2) application prior to making a final decision on a related 505(q) petition (i.e., whether such an approval would be considered a denial of the petition under section 505(q)(2)(A)(i) of the FD&C Act). (Response 5) We believe the statute clearly defines what constitutes an exhaustion of administrative remedies with regard to section 505(q) petitions. Section 505(q)(2) of the FD&C Act governs judicial review of final Agency action on certain petitions filed under section 505(q). Under section 505(q)(2)(A) of the FD&C Act, FDA is considered to have taken final Agency action on a petition if either: (1) FDA makes a final decision within the meaning of Sec. 10.45(d) during the 150-day period or (2) the 150-day period expires without FDA making a final decision. Section 505(q)(2) of the FD&C Act is silent as to the effect of approving an ANDA or a 505(b)(2) application prior to FDA's action on a petition. In our view, the language of section 505(q)(2) of the FD&C Act is clear and decouples a final action on a petition from a decision on an underlying ANDA or 505(b)(2) application. (We note that petitions addressing issues concerning 351(k) applications are excluded from the scope of section 505(q)(2) of the FD&C Act). Therefore, a decision on an ANDA or a 505(b)(2) application that occurs prior to the issuance of a petition response will not constitute final Agency action on the petition. (Comment 6) PhRMA requested that FDA issue a regulation establishing (or clarifying) that a delay in approval of an ANDA or a 505(b)(2) application can extend beyond the 180-day (now 150-day) review period for a petition. (Response 6) We decline to issue a regulation establishing or clarifying that a delay in approval of an ANDA or a 505(b)(2) application can exceed the 150-day review period for petitions. Because of the uncertainty in predicting the time it will take to resolve a particular issue, establishing an expectation on the possible length of a delay would be neither practical nor feasible. We believe that based on the language of section 505(q) of the FD&C Act, no clarification is necessary. (Comment 7) Finally, PhRMA requested that FDA abandon its practice of not providing a substantive response to every section 505(q) petition regardless of the review status of a pending ANDA or 505(b)(2) application. (Response 7) This issue is outside the scope of this rulemaking. FDA's current thinking on this issue is outlined in section III.E of its guidance for industry ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act'' (Ref. 1), and we do not believe further elaboration is necessary. IV. Legal Authority This rule amends Sec. Sec. 10.20, 10.30, and 10.35, and adds Sec. 10.31 in a manner consistent with the Agency's current understanding and application of these provisions. FDA is implementing certain provisions of FDAAA and FDASIA that govern petitions subject to section 505(q) of the FD&C Act. FDA has authority to issue regulations for the efficient administration of these provisions under section 701(a) of the FD&C Act (21 U.S.C. 371(a)). V. Analysis of Environmental Impact FDA has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VI. Economic Analysis of Impacts A. Introduction and Summary We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule (Ref. 2). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the annualized compliance costs to industry members, including small entities, is estimated to be slightly above $100, we certify that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount. B. Summary of Final Regulatory Impacts Analysis 1. Industry Costs We estimate one-time costs to industry from this final rule at about $626,300. We estimate annual costs at about $1,800. These costs equate to an estimated total annualized cost of about $91,000 at a 7 percent discount rate over 10 years and about $75,200 at a 3 percent discount rate over 10 years. The total annualized costs include the administrative cost to review the rule ($89,200) plus the cost for the additional effort preparing certifications for petitions and verifications for both responses to petitions and supplements to petitions ($1,800). 2. Benefits The final rule contains several clarifications to the language provided in FDAAA and small additions to the statute's provisions. It reinforces the need for exact wording of both the certification and verification statements for petitions, supplements to petitions, and responses to petitions. Furthermore, [[Page 78505]] the rule clarifies the exact dating procedures for these documents. By providing additional clarity on the statutory requirements, we expect the final rule will slightly reduce the number of deficient 505(q) petitions. We do not have enough information to estimate this reduction in deficient 505(q) petitions, but the reduction should result in lower administrative costs for both industry and FDA. The Economic Analysis of Impacts of the final rule, performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act, is available at http://www.regulations.gov under the docket number for this final rule (FDA-2011-N-0697) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. VII. Paperwork Reduction Act of 1995 This final rule contains no new information collection provisions that 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 PRA). The final rule refers to previously approved collections of information found in FDA regulations. The collections of information in Sec. Sec. 10.30 and 10.35 have been approved under OMB control number 0910-0191. The collections of information in Sec. 10.31 have been approved under OMB control number 0910-0679. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The certification and verification statements required under Sec. 10.31(c) and (d) are ``public disclosure[s] of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public . . . ,'' (5 CFR 1320.3(c)(2)) and therefore not subject to OMB review. VIII. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. IX. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA Guidance for Industry, ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act,'' November 2014, available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm079353.pdf. 2. Final Regulatory Impact Analysis, ``Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets,'' Docket No. FDA-2011-N-0697, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. List of Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 10 is amended as follows: PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES 0 1. The authority citation for part 10 continues to read as follows: Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264. 0 2. In Sec. 10.20, revise paragraph (e) to read as follows: Sec. 10.20 Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure. * * * * * (e) Except as provided in Sec. 10.31(b), all submissions to the Division of Dockets Management will be considered as submitted on the date they are postmarked or, if delivered in person during regular business hours, on the date on which they are delivered, unless a provision in this part, an applicable Federal Register notice, or an order issued by an administrative law judge specifically states that the documents must be received by a specified date, e.g., Sec. 10.33(g) relating to a petition for reconsideration, in which case they will be submitted on the date received. * * * * * 0 3. Section 10.30 is amended as follows: 0 a. Revise paragraph (b) introductory text; 0 b. Revise the first sentence of paragraph (c); 0 c. Revise the second sentence of paragraph (d); 0 d. Revise the first sentence of paragraph (e)(2); 0 e. Remove from paragraph (e)(2)(ii) the word ``or''; 0 f. Redesignate paragraph (e)(2)(iii) as paragraph (e)(2)(iv); 0 g. Add new paragraph (e)(2)(iii); 0 h. Add to paragraph (e)(3) a new sentence after the first sentence; and 0 i. Add new paragraph (e)(5). The additions and revisions read as follows: Sec. 10.30 Citizen petition. * * * * * (b) A petition (including any attachments) must be submitted in accordance with Sec. 10.20 and, if applicable, Sec. 10.31. The certification requirement in this section does not apply to petitions subject to the certification requirement of Sec. 10.31. The petition must also be submitted in accordance with the following paragraphs, as applicable: * * * * * (c) A petition that appears to meet the requirements of paragraph (b)(3) of this section, Sec. 10.20, and, if applicable, Sec. 10.31, will be filed by the Division of Dockets Management, stamped with the date of filing, and assigned a unique docket number. * * * (d) * * * The comments are to specify the docket number of the petition and include, if applicable, the verification under Sec. 10.31, and may support or oppose the petition in whole or in part. * * * (e) * * * (2) Except as provided in paragraphs (e)(4) and (5) of this section, the Commissioner shall furnish a response to each petitioner within 180 days of receipt of the petition. * * * (iii) Dismiss the petition if at any time the Commissioner determines that changes in law, facts, or circumstances since the date on which the petition was submitted have rendered the petition moot; or * * * * * (3) * * * If, at any time, the Commissioner determines that changes in law, facts, or circumstances since the date on which the petition was submitted have rendered the petition [[Page 78506]] moot, the Commissioner may dismiss the petition. * * * * * * * * (5) The Commissioner intends to furnish a response to each petitioner within 150 days of receipt of a petition subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act. * * * * * 0 4. Add Sec. 10.31 to subpart B to read as follows: Sec. 10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications. (a) Applicability. This section applies to a citizen petition or petition for stay of action that meets all of the following criteria: (1) The petition requests that the Commissioner take any form of action that could, if taken, delay approval of an abbreviated new drug application submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act, a new drug application submitted through the pathway described by section 505(b)(2) of the Federal, Food, Drug and Cosmetic Act, or a biologics license application submitted under section 351(k) of the Public Health Service Act. (2) The petition is submitted on or after September 27, 2007. (3) The petition is submitted in writing and under Sec. 10.30 (for citizen petitions) or Sec. 10.35 (for petitions for stay of action). (b) Date of submission. A petition subject to this section and submitted in accordance with Sec. 10.20, Sec. 10.30, Sec. 10.31, or Sec. 10.35 is regarded as submitted on the date on which the petition is received by the Division of Dockets Management. (c) Certification. (1) FDA will not consider for review a petition that is subject to this section unless the petition is in writing and contains the following certification: [GRAPHIC] [TIFF OMITTED] TR08NO16.000 (2) The certification in paragraph (c)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the certification must contain each estimated relevant date. The information associated with a particular date must be identified. (d) Verification. (1) FDA will not accept for review any supplemental information or comments on a petition that is subject to this section unless the supplemental information or comments are in writing and contain the following verification: [GRAPHIC] [TIFF OMITTED] TR08NO16.001 (2) The verification in paragraph (d)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the verification must contain each estimated relevant date. The information associated with a particular date must be identified. 0 5. In Sec. 10.35 revise the third sentence of paragraph (b); in paragraph (e) [[Page 78507]] introductory text add a new sentence after the second sentence; and add paragraph (i) to read as follows: Sec. 10.35 Administrative stay of action. * * * * * (b) * * * A request for stay must be submitted in accordance with Sec. 10.20 and in the following form (except that a request for stay subject to Sec. 10.31 must also include the certification provided in Sec. 10.31(c)) no later than 30 days after the date of the decision involved. * * * * * * * * (e) * * * If, at any time, the Commissioner determines that changes in law, facts, or circumstances since the date on which the petition was submitted have rendered the petition moot, the Commissioner may dismiss the petition. * * * * * * * * (i) A petitioner may supplement, amend, or withdraw a petition for stay of action in writing without Agency approval and without prejudice to resubmission at any time until the Commissioner rules on the petition, provided the resubmission is made in accordance with paragraph (b) of this section, unless the petition for stay of action has been referred for a hearing under parts 12, 13, 14, or 15 of this chapter. After a ruling or referral, a petition for stay of action may be supplemented, amended, or withdrawn only with the approval of the Commissioner. The Commissioner may approve withdrawal with or without prejudice against resubmission of the petition for stay of action. Dated: November 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26912 Filed 11-7-16; 8:45 am] BILLING CODE 4164-01-P
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proper use of the product’’ refers to DEPARTMENT OF HEALTH AND III. Comments on the Proposed Rule and FDA
vaccination schedules, revaccination HUMAN SERVICES Responses
A. Introduction
schedules (if necessary), indications for
Food and Drug Administration B. Scope of the Proposed Rule (§ 10.31)
use, target species, recommended age C. Certification and Verification
for vaccination, vaccination route(s), Requirements
and product license restrictions 21 CFR Part 10 D. Nonretroactivity of the Rule
prescribed by the Animal and Plant [Docket No. FDA–2011–N–0697] E. Additional Comments
Health Inspection Service that have a IV. Legal Authority
RIN 0910–AG26 V. Analysis of Environmental Impact
bearing on product use. However, when VI. Economic Analysis of Impacts
we made that change, we inadvertently Amendments to Regulations on Citizen A. Introduction and Summary
removed a requirement for an Petitions, Petitions for Stay of Action, B. Summary of Final Regulatory Impacts
indications statement to appear on final and Submission of Documents to Analysis
container labels, carton labels, and Dockets VII. Paperwork Reduction Act of 1995
enclosures. Therefore, we are amending VIII. Federalism
AGENCY: Food and Drug Administration, IX. References
§ 112.2(a) to re-establish the HHS.
requirement for an indications Executive Summary
ACTION: Final rule.
statement. Purpose of the Rule
SUMMARY: The Food and Drug
List of Subjects in 9 CFR Part 112 This rule establishes new regulations
Administration (FDA, the Agency, or
we) is amending certain regulations implementing section 505(q) of the
Animal biologics, Exports, Imports, FD&C Act (21 U.S.C. 355(q)) as enacted
Labeling, packaging and containers, relating to citizen petitions, petitions for
stay of action (PSAs), and the by FDAAA (Pub. L. 110–85) and
Reporting and recordkeeping amended by FDASIA (Pub. L. 112–144).
requirements. submission of documents to the Agency.
In particular, the final rule establishes Section 505(q) of the FD&C Act governs
Accordingly, we are amending 9 CFR new regulations to implement certain the manner in which FDA handles
part 112 as follows: provisions of the Federal Food, Drug, certain citizen petitions and PSAs that
and Cosmetic Act (the FD&C Act), ask the Agency to take any form of
PART 112—PACKAGING AND which concern certain citizen petitions action related to an ANDA, a 505(b)(2)
LABELING and PSAs that involve a request for FDA application, or an application submitted
to take any form of action relating to a under section 351(k) of the PHS Act
■ 1. The authority citation for part 112 pending abbreviated new drug (351(k) application) (42 U.S.C. 262(k)).
continues to read as follows: application (ANDA), 505(b)(2) Section 505(q) of the FD&C Act specifies
application, or certain applications that FDA must not delay approval of a
Authority: 21 U.S.C. 151–159; 7 CFR 2.22, pending application because of any
submitted under the Public Health
2.80, and 371.4. request to take any form of action
Service Act (PHS Act). We are making
■ 2. Section 112.2 is amended by adding these changes to implement provisions relating to the application, unless the
paragraph (a)(12) to read as follows: of the Food and Drug Administration request is in writing and in a citizen
Amendments Act of 2007 (FDAAA) and petition or a PSA, and the Agency
§ 112.2 Final container label, carton label, the Food and Drug Administration determines, upon reviewing the
and enclosure. Safety and Innovation Act (FDASIA). petition, that a delay is necessary to
DATES: This rule is effective January 9, protect the public health. Section 505(q)
(a) * * * of the FD&C Act also requires that all
2017.
(12) An indications statement to read, submitters of a petition (or PSA) include
ADDRESSES: For access to the docket to
‘‘This product has been shown to be with their submission a verbatim
read background documents or
effective for the vaccination of healthy certification statement specifying the
comments received, go to http://
(insert name of species) __ weeks of age www.regulations.gov and insert the date on which the information relied on
or older against __.’’ Provided, That in docket number (FDA–2011–N–0697) in the petition first became known.
the case of very small final container into the ‘‘Search’’ box and follow the Similarly, section 505(q) of the FD&C
labels or carton, a statement as to where prompts and/or go to the Division of Act requires that the submitters of a
such information is to be found, such as Dockets Management, 5630 Fishers supplement or a comment to a petition
‘‘See enclosure for complete directions,’’ Lane, Rm. 1061, Rockville, MD 20852. include with their submission a
‘‘Full directions on carton,’’ or verbatim verification statement
FOR FURTHER INFORMATION CONTACT:
comparable statement. specifying the date on which the
Darren Eicken, Center for Drug information relied on in their
* * * * * Evaluation and Research, Food and submission first became known. By
Done in Washington, DC, this 2nd day of
Drug Administration, 10903 New enacting section 505(q) of the FD&C Act,
November 2016. Hampshire Ave., Bldg. 51, Rm. 6206, Congress indicated a desire to ensure
Silver Spring, MD, 20993–0002, 240– that petitions not be used to improperly
Kevin Shea,
402–0978. delay approval of ANDAs, 505(b)(2)
Administrator, Animal and Plant Health SUPPLEMENTARY INFORMATION:
Inspection Service. applications, or 351(k) applications.
[FR Doc. 2016–26936 Filed 11–7–16; 8:45 am] Table of Contents This rule clarifies the requirements of
section 505(q) of the FD&C Act.
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BILLING CODE 3410–34–P Executive Summary
I. Background Summary of the Major Provisions of the
II. Overview of the Final Rule, Including Rule
Significant Changes to the Proposed Rule
A. Overview This rule amends FDA’s regulations
B. Significant Changes to the Proposed on general administrative procedures in
Rule part 10 (21 CFR part 10).
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days after the date on which the petition FDA also is making editorial and • Adds § 10.30(e)(5) to incorporate a
is submitted. The 150-day period is not organizational changes to clarify statutory change enacted by FDASIA.
to be extended for any reason, including provisions. The final rule amends part New § 10.30(e)(5) states that FDA
any determination made under section 10 of FDA regulations on general intends to respond to a petition subject
505(q)(1)(A) of the FD&C Act regarding administrative procedures. The to section 505(q) of the FD&C Act within
delay of approval of an application (i.e., amendment adds § 10.31, which 150 days after the date on which the
that delay is necessary to protect the includes the following provisions: petition is received.
public health), the submission of • Section10.31(a) states that § 10.31 • Revises § 10.30(e)(2) to conform
comments or supplemental information, will encompass all citizen petitions and with the addition of § 10.30(e)(5).
or the consent of the petitioner. In PSAs that request that the Agency take
addition, FDA may deny a petition at any action that could, if taken, delay • Makes minor revisions to §§ 10.20
any point if it determines that a petition approval of an ANDA, a 505(b)(2) and 10.30 to conform to the addition of
or a supplement to the petition was application, or a 351(k) application (i.e., § 10.31.
submitted with the primary purpose of petitions and PSAs that are or may be • With respect to § 10.35,
delaying the approval of an application subject to section 505(q) of the FD&C administrative stay of action, makes
and the petition does not on its face Act). revisions to conform with the
raise valid scientific or regulatory issues • Section 10.31(b) clarifies the date of implementation of section 505(q) of the
(section 505(q)(1)(E) of the FD&C Act). submission for petitions submitted FD&C Act. The final rule also adds new
Section 505(q) of the FD&C Act also under § 10.31. § 10.35(i) to clarify that a petitioner
includes certification and verification • Section 10.31(c) and (d) codify the requesting a stay of action may
requirements for certain documents. certification and verification supplement, amend, or withdraw a PSA,
Under section 505(q)(1)(H) of the FD&C requirements of section 505(q)(1)(H) and similar to the provision for citizen
Act, FDA may not consider a petition (I) of the FD&C Act. Section 10.31(c) petitions in current § 10.30(g).
for review unless the petition is in clarifies that the Agency will consider a In addition to implementing the
writing and is signed and contains a certification deficient if every word in provisions in section 505(q) of the FD&C
certification that is specified in that the petitioner’s certification does not Act, the final rule makes minor
section. Section 505(q)(1)(H) of the match every word of the certification technical changes by revising
FD&C Act sets forth the exact words to provided in section 505(q)(1)(H) of the
be used in the certification. In addition, §§ 10.30(e)(3) and 10.35(e) to allow the
FD&C Act. Likewise, § 10.31(d) clarifies Commissioner to dismiss a petition if
FDA may not accept for review any that the Agency will consider the
supplemental information or comments changes in law, facts, or circumstances
verification deficient if every word in since the date on which the petition was
on a petition unless the submission is in the petitioner’s or commenter’s
writing and is signed and contains a submitted render the petition moot.
verification does not match every word
specific verification. Section 505(q)(1)(I) of the verification provided in section B. Significant Changes to the Proposed
of the FD&C Act sets forth the exact 505(q)(1)(I) of the FD&C Act. As Rule
words to be used in the verification. discussed in section II.B.4 of the
Section 505(q)(2) of the FD&C Act preamble to the proposed rule, we are The final rule reflects revisions to the
governs judicial review of final Agency making one minor editorial change to proposed rule in response to the
action on a petition subject to section the language of the verification set out enactment of FDASIA. Section 1135 of
505(q). Under section 505(q)(2)(A) of the in the statute. We are changing ‘‘I verify FDASIA amended section 505(q) of the
FD&C Act, FDA will be considered to under penalty of perjury that the FD&C Act in several ways. First, it
have taken final Agency action on a foregoing is true and correct as of the shortened from 180 days to 150 days
petition if FDA makes a final decision date of this petition’’ to ‘‘I verify under FDA’s deadline for responding to
within the meaning of § 10.45(d) during penalty of perjury that the foregoing is petitions subject to section 505(q) of the
the 150-day period, or the 150-day true and correct as of the date of this FD&C Act. Second, it expanded the
period expires without FDA having document’’ (emphasis added). Because scope of section 505(q) of the FD&C Act
made a final decision. Under section the statute specifies the word to include certain petitions related to
505(q)(2)(B) of the FD&C Act, if a civil ‘‘petition’’, we will accept either 351(k) applications. Lastly, FDASIA also
action is filed against the Secretary with ‘‘petition’’ or ‘‘document’’ in the last added section 505(q)(4)(B) of the FD&C
respect to any issues raised in the sentence of the verification. In addition, Act, which excludes such petitions from
petition before final Agency action, a section 505(q) of the FD&C Act requires section 505(q)(2).
court shall dismiss the action without both the certification and verification to Accordingly, the final rule includes
prejudice for failure to exhaust be signed and executed under penalty of the following changes to the proposed
administrative remedies. Section perjury. FDA interprets the signature rule:
505(q)(2) of the FD&C Act, however, provision to require a handwritten or
does not apply to a petition containing • Adds § 10.30(e)(5) and revises
electronic signature by the person § 10.30(e)(2) to reflect FDA’s 150-day
requests relating to a 351(k) application. whose name appears as the signatory to deadline for responding to petitions
II. Overview of the Final Rule, the petition, supplement, or comment. If subject to section 505(q) of the FD&C
Including Significant Changes to the the certification or verification is signed Act.
Proposed Rule by another person with the notation
‘‘for,’’ signature/[initials], ‘‘on behalf • Revises § 10.31(a)(1) to reflect the
A. Overview of,’’ or with similar notation that applicability of section 505(q) of the
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In this rulemaking, the Agency indicates one person signed for another, FD&C Act to 351(k) applications.
finalizes the provisions outlined in the we will consider the certification or These changes conform the final rule
January 2012 proposed rule. In addition, verification to be deficient and will not to reflect amendments to section 505(q)
the final rule incorporates changes consider the petition for review. of the FD&C Act enacted by FDASIA
enacted by FDASIA and responds to The final rule amends §§ 10.20, 10.30, that became law after publication of the
comments made to the proposed rule. and 10.35 as follows: proposed rule.
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III. Comments on the Proposed Rule the certification is required (because of list different types of information. A
and FDA Responses the existence of a pending application), petition, supplement, or comment will
the filing of petitions could become a meet the certification/verification
A. Introduction
way for individuals to uncover the requirement if it contains a date
We received one submission existence of certain pending followed by a short description of the
containing several comments from the applications. Neither FDAAA nor information. This requirement is
Pharmaceutical Research and FDASIA suggest such an outcome. essential to carrying out the legislative
Manufacturers of America (PhRMA). Moreover, rather than causing intent of Congress and does not impose
These comments primarily focused on confusion, as PhRMA suggests, we an unreasonable burden on petitioners.
the scope of proposed § 10.31 and the believe that requiring certifications and Because of the fact-based nature of a
certification and verification verifications for all applicable petitions petition, it is impracticable for FDA to
requirements. PhRMA also raised would remove any uncertainty as to specifically define or categorize all
several issues we deemed outside the whether a petitioner should submit or types of information that may be relied
scope of the proposed rule. In the not submit a certification or verification. upon by a petitioner. A petitioner or
discussion that follows, we address the If there is no related ANDA, 505(b)(2) commenter can, however, reasonably be
comments. application, or 351(k) application expected to identify the main categories
We describe and respond to the pending at the time the petition is of information on which the petition,
comments in sections III.B through III.E. submitted, then the requirements of supplement, or comment relies and to
We have numbered each comment to § 10.31 will apply to the petition, but we provide dates for such categories.
help distinguish between different will not consider the provisions of Indeed, this interpretation of the
comments. The number assigned to each section 505(q) of the FD&C Act to apply certification has worked well to date.
comment is purely for organizational to the petition. The failure to certify or verify a ‘‘became
purposes and does not signify the known’’ date for any item of information
comment’s value or importance or the C. Certification and Verification
contained in a petition would preclude
order in which comments were Requirements
the petitioner from relying on that
received. (Comment 2) PhRMA expressed information when seeking judicial
B. Scope of the Proposed Rule (§ 10.31) specific concerns regarding the review since section 505(q)(1)(H) and (I)
certification and verification of the FD&C Act requires that FDA not
(Comment 1) We received a comment requirements of the rule. First, PhRMA consider and/or accept for review any
from PhRMA concerning the scope of requested that the discretionary petition or information that fails to meet
the rule. PhRMA stated that, in some language found in the preamble to the the certification and verification
instances, the rule would require proposed rule, i.e., ‘‘[t]he failure to requirements.
unnecessary certifications for petitions provide any information relied upon
outside the scope of section 505(q) of (and the date) in the certification or D. Nonretroactivity of the Rule
the FD&C Act that could cause verification may result in the failure of (Comment 3) PhRMA expressed
confusion among petitioners, FDA to consider that information . . . concern that the rule could be read as
commentators, and the courts regarding .’’, be clarified to prevent confusion over retroactively imposing requirements on
which rules to apply to any given how FDA intends to interpret and petitions filed after September 26, 2007,
petition. PhRMA claimed the proposed implement the certification and but before the effective date of the final
rule could compromise a petitioner’s verification requirements. Second, rule. Based on its concern, PhRMA
fundamental right to know which PhRMA questioned FDA’s assertion that requested that FDA revise the rule to
statutory requirements and timelines a failure to certify or verify a ‘‘became clarify that § 10.31 will not apply to any
FDA will apply to the petition. known’’ date would foreclose a petition that was pending at FDA before
Accordingly, PhRMA requested that petitioner from relying on that the final rule’s effective date, to any
FDA revise the proposed rule to limit information when seeking judicial supplement to such a petition, or to any
the rule’s application to cases in which review. Accordingly, PhRMA requested comments on such a petition.
there is evidence that a relevant ANDA that FDA: (1) Revise the proposed rule (Response 3) FDA’s guidance for
or 505(b)(2) application is pending and provide additional explanation and industry ‘‘Citizen Petitions and Petitions
before FDA. examples to clarify what types of for Stay of Action Subject to Section
(Response 1) We decline to make this information petitioners must provide 505(q) of the Federal Food, Drug, and
revision. Normally, the existence of a ‘‘became known’’ dates for and (2) Cosmetic Act’’ (Ref. 1), describes FDA’s
pending application is not made public ‘‘provide support for, modify, or current thinking on the applicability of
by FDA. (See e.g., 21 CFR 314.430.) To expressly withdraw’’ the preamble section 505(q) to petitions submitted
prevent uncertainty as to when a statement concerning judicial review. after September 27, 2007. As that
certification or verification is required (Response 2) We recognize that a guidance notes, section 505(q) of the
and to protect against the unintended petition, supplement, or comment could FD&C Act applies to all petitions that
release of information acknowledging be based on more than one type of are submitted on or after September 27,
the existence of an ANDA, a 505(b)(2) information or multiple pieces of 2007 (or July 9, 2012, if the subject
application, or a 351(k) application, we information. Section 505(q) of the FD&C matter of the petition relates to the
are making § 10.31 apply to all petitions Act requires that the petitioner provide approval of a 351(k) application). To the
that request an action that could delay in the certification the date on or about extent the final rule imposes any
the approval of an ANDA, a 505(b)(2) which information first became known additional requirements, those
application, or a 351(k) application, to the petitioner. We interpret section requirements will apply only to those
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regardless of whether an application 505(q) of the FD&C Act to require an on petitions submitted on or after the
subject to the petition’s requested action or about date for each piece of effective date of the final rule.
is pending at the time the petition is information that is relied upon in the
submitted. Otherwise, if petitioners petition. Section II.B.7 of the preamble E. Additional Comments
were to omit the certification statement to the proposed rule provides an (Comment 4) PhRMA requested that
and wait for FDA to inform them that example illustrating how a petition may FDA include or otherwise establish a
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the rule clarifies the exact dating IX. References reconsideration, in which case they will
procedures for these documents. By be submitted on the date received.
The following references are on
providing additional clarity on the * * * * *
display in the Division of Dockets
statutory requirements, we expect the ■ 3. Section 10.30 is amended as
Management (see ADDRESSES) and are
final rule will slightly reduce the follows:
available for viewing by interested
number of deficient 505(q) petitions. We ■ a. Revise paragraph (b) introductory
do not have enough information to persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also text;
estimate this reduction in deficient ■ b. Revise the first sentence of
505(q) petitions, but the reduction available electronically at http://
www.regulations.gov. FDA has verified paragraph (c);
should result in lower administrative ■ c. Revise the second sentence of
costs for both industry and FDA. the Web site addresses, as of the date
this document publishes in the Federal paragraph (d);
The Economic Analysis of Impacts of ■ d. Revise the first sentence of
the final rule, performed in accordance Register, but Web sites are subject to
change over time. paragraph (e)(2);
with Executive Order 12866, Executive ■ e. Remove from paragraph (e)(2)(ii)
Order 13563, the Regulatory Flexibility 1. FDA Guidance for Industry, ‘‘Citizen
the word ‘‘or’’;
Act, and the Unfunded Mandates Petitions and Petitions for Stay of Action
■ f. Redesignate paragraph (e)(2)(iii) as
Reform Act, is available at http:// Subject to Section 505(q) of the Federal
Food, Drug, and Cosmetic Act,’’ paragraph (e)(2)(iv);
www.regulations.gov under the docket ■ g. Add new paragraph (e)(2)(iii);
number for this final rule (FDA–2011– November 2014, available at http://
www.fda.gov/ucm/groups/fdagov-public/ ■ h. Add to paragraph (e)(3) a new
N–0697) and at http://www.fda.gov/ sentence after the first sentence; and
@fdagov-drugs-gen/documents/
AboutFDA/ReportsManualsForms/ document/ucm079353.pdf. ■ i. Add new paragraph (e)(5).
Reports/EconomicAnalyses/default.htm. 2. Final Regulatory Impact Analysis, The additions and revisions read as
VII. Paperwork Reduction Act of 1995 ‘‘Amendments to Regulations on Citizen follows:
Petitions, Petitions for Stay of Action,
This final rule contains no new and Submission of Documents to § 10.30 Citizen petition.
information collection provisions that Dockets,’’ Docket No. FDA–2011–N– * * * * *
are subject to review by the Office of 0697, available at http://www.fda.gov/
(b) A petition (including any
Management and Budget (OMB) under AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm. attachments) must be submitted in
the Paperwork Reduction Act of 1995 accordance with § 10.20 and, if
(44 U.S.C. 3501–3520) (the PRA). The List of Subjects in 21 CFR Part 10 applicable, § 10.31. The certification
final rule refers to previously approved
Administrative practice and requirement in this section does not
collections of information found in FDA
procedure, News media. apply to petitions subject to the
regulations. The collections of
certification requirement of § 10.31. The
information in §§ 10.30 and 10.35 have Therefore, under the Federal Food, petition must also be submitted in
been approved under OMB control Drug, and Cosmetic Act and under accordance with the following
number 0910–0191. The collections of authority delegated to the Commissioner paragraphs, as applicable:
information in § 10.31 have been of Food and Drugs, 21 CFR part 10 is
approved under OMB control number * * * * *
amended as follows:
0910–0679. The collections of (c) A petition that appears to meet the
information in 21 CFR part 314 have PART 10—ADMINISTRATIVE requirements of paragraph (b)(3) of this
been approved under OMB control PRACTICES AND PROCEDURES section, § 10.20, and, if applicable,
number 0910–0001. The certification § 10.31, will be filed by the Division of
and verification statements required ■ 1. The authority citation for part 10 Dockets Management, stamped with the
under § 10.31(c) and (d) are ‘‘public continues to read as follows: date of filing, and assigned a unique
disclosure[s] of information originally docket number. * * *
Authority: 5 U.S.C. 551–558, 701–706; 15
supplied by the Federal government to U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–
(d) * * * The comments are to
the recipient for the purpose of 397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 specify the docket number of the
disclosure to the public . . . ,’’ (5 CFR U.S.C. 201, 262, 263b, 264. petition and include, if applicable, the
1320.3(c)(2)) and therefore not subject to verification under § 10.31, and may
■ 2. In § 10.20, revise paragraph (e) to
OMB review. support or oppose the petition in whole
read as follows:
or in part. * * *
VIII. Federalism § 10.20 Submission of documents to (e) * * *
We have analyzed this final rule in Division of Dockets Management; (2) Except as provided in paragraphs
accordance with the principles set forth computation of time; availability for public (e)(4) and (5) of this section, the
in Executive Order 13132. FDA has disclosure. Commissioner shall furnish a response
determined that the rule does not * * * * * to each petitioner within 180 days of
contain policies that have substantial (e) Except as provided in § 10.31(b), receipt of the petition. * * *
direct effects on the States, on the all submissions to the Division of (iii) Dismiss the petition if at any time
relationship between the National Dockets Management will be considered the Commissioner determines that
Government and the States, or on the as submitted on the date they are changes in law, facts, or circumstances
distribution of power and postmarked or, if delivered in person since the date on which the petition was
responsibilities among the various during regular business hours, on the submitted have rendered the petition
levels of government. Accordingly, we date on which they are delivered, unless moot; or
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conclude that the rule does not contain a provision in this part, an applicable * * * * *
policies that have federalism Federal Register notice, or an order (3) * * * If, at any time, the
implications as defined in the Executive issued by an administrative law judge Commissioner determines that changes
order and, consequently, a federalism specifically states that the documents in law, facts, or circumstances since the
summary impact statement is not must be received by a specified date, date on which the petition was
required. e.g., § 10.33(g) relating to a petition for submitted have rendered the petition
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![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Rules and Regulations 78507
introductory text add a new sentence channel from mile marker 285.0 to mile December 10, 2016 will be a safety
after the second sentence; and add marker 289.0 on the Gulf Intracoastal concern for anyone within the area of
paragraph (i) to read as follows: Waterway in Panama City, FL. The the Gulf Intracoastal Waterway between
special local regulation is needed to mile marker 285.0 and mile marker
§ 10.35 Administrative stay of action. protect the persons participating in the 289.0. This rule is needed to protect
* * * * * Boat Parade of Lights marine event. This participants, spectators, and other
(b) * * * A request for stay must be rulemaking restricts transit into, through persons and vessels during the regatta
submitted in accordance with § 10.20 and within the regulated area unless on navigable waters.
and in the following form (except that specifically authorized by the Captain of
a request for stay subject to § 10.31 must IV. Discussion of the Rule
the Port Mobile.
also include the certification provided DATES: This rule is effective from 4 p.m. This rule establishes a special local
in § 10.31(c)) no later than 30 days after until 10 p.m. on December 10, 2016. regulation on December 10, 2016, which
the date of the decision involved. * * * ADDRESSES: To view documents
will be enforced between the hours of 4
* * * * * mentioned in this preamble as being p.m. and 10 p.m. The special local
(e) * * * If, at any time, the available in the docket, go to http:// regulation takes place on the Gulf
Commissioner determines that changes www.regulations.gov, type USCG–2016– Intracoastal Waterway between mile
in law, facts, or circumstances since the 0932 in the ‘‘SEARCH’’ box and click marker 285.0 and mile marker 289.0,
date on which the petition was ‘‘SEARCH.’’ Click on Open Docket extending the entire width of the
submitted have rendered the petition Folder on the line associated with this navigable channel. A similar special
moot, the Commissioner may dismiss rule. local regulation is currently in the Code
the petition. * * * of Federal Regulations under 33 CFR
FOR FURTHER INFORMATION CONTACT: If
100.801, Table 7, number 15 as
* * * * * you have questions on this rule, call or occurring ‘‘1 Day; Saturday following
(i) A petitioner may supplement, email LT Fannie L. Wilks, Sector Thanksgiving.’’ However, for the 2016
amend, or withdraw a petition for stay Mobile, Waterways Management occurrence, the event sponsors changed
of action in writing without Agency Division, U.S. Coast Guard; telephone the date of the event to December 10,
approval and without prejudice to 251–441–5940, email Fannie.L.Wilks@
2016. The duration of the regulation is
resubmission at any time until the uscg.mil.
intended to protect participants,
Commissioner rules on the petition, SUPPLEMENTARY INFORMATION: spectators, and other persons and
provided the resubmission is made in vessels before, during, and after the
accordance with paragraph (b) of this I. Table of Abbreviations
regatta. No vessel or person will be
section, unless the petition for stay of CFR Code of Federal Regulations permitted to enter, transit within or
action has been referred for a hearing DHS Department of Homeland Security through, or exit the regulated area
under parts 12, 13, 14, or 15 of this FR Federal Register
NPRM Notice of proposed rulemaking without obtaining permission from the
chapter. After a ruling or referral, a COTP or a designated representative.
petition for stay of action may be PATCOM Patrol Commander
§ Section Spectator vessels desiring to enter,
supplemented, amended, or withdrawn U.S.C. United States Code transit through or within, or exit the
only with the approval of the regulated area may request permission
Commissioner. The Commissioner may II. Background Information and
to do so from the Patrol Commander.
approve withdrawal with or without Regulatory History
When permitted to transit the area
prejudice against resubmission of the The Coast Guard is issuing this vessels must follow restrictions within
petition for stay of action. temporary rule without prior notice and the regulated area as directed by the
Dated: November 2, 2016. opportunity to comment pursuant to Coast Guard, and must operate at a
Leslie Kux, authority under section 4(a) of the minimum safe navigation speed in a
Associate Commissioner for Policy. Administrative Procedure Act (APA) (5 manner which will not endanger
[FR Doc. 2016–26912 Filed 11–7–16; 8:45 am]
U.S.C. 553(b)). This provision participants in the regulated area or any
authorizes an agency to issue a rule other vessels.
BILLING CODE 4164–01–P
without prior notice and opportunity to
comment when the agency for good V. Regulatory Analyses
cause finds that those procedures are We developed this rule after
DEPARTMENT OF HOMELAND ‘‘impracticable, unnecessary, or contrary considering numerous statutes and
SECURITY to the public interest.’’ Under 5 U.S.C. Executive orders related to rulemaking.
553(b)(B), the Coast Guard finds that Below we summarize our analyses
Coast Guard
good cause exists for not publishing a based on a number of these statutes and
notice of proposed rulemaking (NPRM) Executive orders, and we discuss First
33 CFR Part 100
with respect to this rule because doing Amendment rights of protestors.
[Docket Number USCG–2016–0932] so would be impracticable. At this time,
A. Regulatory Planning and Review
it would be impracticable to complete
RIN 1625–AA08 Executive Orders 12866 and 13563
the full notice and comment process
because this special local regulation direct agencies to assess the costs and
Special Local Regulation; Saint
must be established on December 10, benefits of available regulatory
Andrew Bay; Panama City, FL
2016. alternatives and, if regulation is
AGENCY: Coast Guard, DHS. necessary, to select regulatory
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III. Legal Authority and Need for Rule approaches that maximize net benefits.
ACTION: Temporary final rule.
The Coast Guard is issuing this rule Executive Order 13563 emphasizes the
SUMMARY: The Coast Guard is under authority in 33 U.S.C. 1233. The importance of quantifying both costs
establishing a temporary special local Captain of the Port Mobile (COTP) has and benefits, of reducing costs, of
regulation on Saint Andrew Bay determined that potential hazards harmonizing rules, and of promoting
extending the entire width of the associated with the regatta event on flexibility. This rule has not been
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Document Created: 2018-02-14 08:23:56
Document Modified: 2018-02-14 08:23:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective January 9, 2017. | |
| Contact | Darren Eicken, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD, 20993-0002, 240- 402-0978. | |
| FR Citation | 81 FR 78500 | |
| RIN Number | 0910-AG26 | |
| CFR Associated | Administrative Practice and Procedure and News Media |
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