81 FR 52995 - New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 155 (August 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 155 (August 11, 2016)
| Page Range | 52995-52997 | |
| FR Document | 2016-18809 |
[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)] [Rules and Regulations] [Pages 52995-52997] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18809] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2016-N-1943] New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correcting amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations. DATES: This rule is effective August 11, 2016. ADDRESSES: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule 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: Vernon Toelle, Center for Veterinary Medicine (HFV-234), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5637, [email protected]. SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Legal Authority III. Effective Date IV. Economic Analysis of Impacts V. Analysis of Environmental Impact VI. Paperwork Reduction Act of 1995 VII. Federalism [[Page 52996]] I. Background This regulation is intended to make technical amendments to Sec. 514.200 (21 CFR 514.200) to harmonize the terminology with part 12 (21 CFR part 12), as well as to update Sec. 514.200 in accordance with plain language principles to make it easier for the public to understand and follow. When the Agency issued procedural regulations for formal evidentiary public hearings, originally published in part 2 (21 CFR part 2) and later redesignated to part 12,\1\ we intended those provisions to apply to all formal evidentiary hearings on new product applications, including new animal drug applications. As explained in the proposed rule, once the specific provisions in 21 CFR parts 511 and 514 relating to investigational and marketed new animal drugs were revised in the same way as their counterpart provisions relating to investigational and marketed new drugs, to refer to the new procedural provisions in part 2, the prior procedural provisions relating to hearings would be revoked.\2\ --------------------------------------------------------------------------- \1\ See 41 FR 51706, November 23, 1976, and 42 FR 4680, January 25, 1977. \2\ See 40 FR 40682 at 40716, September 3, 1975. --------------------------------------------------------------------------- Consequently, when part 12 was finalized, we revised the regulations specific to new animal drugs. These revisions included revoking certain provisions and revising 21 CFR 514.201 to state that hearings related to new animal drugs under section 512(d) and (e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(d) and (e)) shall be governed by part 12 of this chapter. However, when we made these revisions to part 514, we neglected to update Sec. 514.200 to match the terminology used in part 12. Therefore, we are now revising Sec. 514.200 to make its language and terminology consistent with the language and terminology of the procedural regulations for hearings in part 12. Specifically, we are changing the references to ``administrative law judge'' in current Sec. 514.200 to the term ``presiding officer'', which is defined in 21 CFR 10.3 \3\ and further explained in 21 CFR 12.60 as the presiding officer in a hearing will be the Commissioner, a member of the Commissioner's office to whom the responsibility for the matter involved has been delegated, or an administrative law judge qualified under 5 U.S.C. 3105. Since the term ``presiding officer'' is used throughout part 12, we are updating the language of Sec. 514.200 to use the same terminology. We are also updating the language in current Sec. 514.200 from ``written appearance'' to ``objections and request for a hearing'' since the latter terminology is used throughout part 12. Finally, we are updating the language in Sec. 514.200 on the contents of the objections and request for hearing and the contents of the Commissioner's notice granting a hearing to match the language of part 12 and to make clear what is required. These updates will eliminate confusion that could be caused by use of different terms to refer to the same procedural requirements and allow the reader to obtain necessary information in one place. We anticipate these technical changes will make Sec. 514.200 easier for the public to understand and follow. --------------------------------------------------------------------------- \3\ ``Presiding officer means the Commissioner or the Commissioner's designee or an administrative law judge appointed as provided in 5 U.S.C. 3105.'' --------------------------------------------------------------------------- Since we are revising Sec. 514.200 to harmonize the language and terminology with part 12, we are also taking this opportunity to update the language of Sec. 514.200 in accordance with the Plain Writing Act of 2010 (Pub. L. 111-274) and Executive Order 13563. The Plain Writing Act of 2010 requires that all Federal agencies use ``clear government communication that the public can understand and use.'' Executive Order 13563 mandates that all regulations be ``accessible, consistent, written in plain language, and easy to understand.'' Therefore, we are eliminating gender-specific pronouns, passive voice, complicated sentence structure, and archaic language, and updating the language to make it more reader-friendly and accessible. We anticipate that these changes will make Sec. 514.200 clearer and easier to read. Additionally, we are updating the title of that section from ``Contents of notice of opportunity for a hearing'' to ``Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing'' because the latter title more accurately describes the type of information found in Sec. 514.200. The latter title also harmonizes with an analogous section for new drug applications in 21 CFR 314.200. All of these corrections are nonsubstantive, technical amendments designed to harmonize the language and terminology of Sec. 514.200 with the governing regulation on formal evidentiary public hearings in part 12 and to make the language of Sec. 514.200 easier for the public to understand and follow. We are taking this action as a part of our Retrospective Review Initiative \4\ to clarify and harmonize the regulations and to update the language in accordance with the Plain Writing Act of 2010 and Executive Order 13563. --------------------------------------------------------------------------- \4\ See E.O. 13563, section 6. --------------------------------------------------------------------------- II. Legal Authority FDA is issuing these regulations under section 512(e) of the FD&C Act. This section gives the Secretary of Health and Human Services the authority to grant approval, deny approval, or withdraw approval of new animal drug applications. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act. Section 6 of Executive Order 13563 states that FDA is under a continuing obligation to review its existing regulations periodically to determine whether any such regulations should be modified, streamlined, expanded, or repealed to improve regulatory effectiveness and reduce public burden. The Plain Writing Act of 2010 mandates that all regulations be written in clear language that is easy for the public to understand and use. This rule makes technical amendments to Sec. 514.200 to harmonize the language and terminology with the governing regulation on administrative hearings in part 12 and to update the language in accordance with the Plain Writing Act of 2010 and Executive Order 13563. Publication of this document constitutes final action on these changes under the Agency's original intent with respect to the hearing provisions for new animal drug applications. Therefore, for good cause, FDA finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary. III. Effective Date These regulations are effective upon publication. IV. Economic Analysis of Impacts 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. We believe that this final rule is not a significant [[Page 52997]] 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 this rule is making only technical amendments, 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. V. Analysis of Environmental Impact We have determined under 21 CFR 25.31(i) 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. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, FDA is not required to seek clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). VII. 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. List of Subjects in 21 CFR Part 514 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 514 is amended as follows: PART 514--NEW ANIMAL DRUG APPLICATIONS 0 1. The authority citation for part 514 continues to read: Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 371, 379e, 381. 0 2. Revise Sec. 514.200 to read as follows: Sec. 514.200 Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing. (a) The notice to the applicant of opportunity for a hearing on a proposal by the Commissioner to refuse to approve an application or to withdraw the approval of an application will be published in the Federal Register together with an explanation of the grounds for the proposed action. The notice will describe how to request a hearing. An applicant has 30 days after publication of the notice to request a hearing. (b) If the applicant fails to request a hearing within the 30-day timeframe, the Commissioner, without further notice, will publish a final order denying or withdrawing approval of the application. (c) If the applicant desires to request a hearing: (1) Within 30 days after publication of the notice of opportunity for hearing, the applicant must submit to the Division of Dockets Management written objections and a request for a hearing in accordance with Sec. Sec. 12.20 and 12.22. This request for a hearing must include each specific objection to the proposal on which a hearing is requested, together with a detailed description and analysis of the factual information (including all relevant clinical and other investigational data) the applicant will present in support of that objection. A request for a hearing may not rest upon mere allegations or denials or general descriptions of positions or contentions, but must set forth specific reliable evidence showing there is a genuine and substantial issue of fact that requires a hearing. (2) If the Commissioner determines upon review of the data and information submitted in the objections and request for a hearing that a hearing is not justified because no genuine and substantial issue of fact precludes the refusal to approve the application or the withdrawal of approval of the application (for example, the applicant has not identified any adequate and well-controlled clinical investigations to support the claims of effectiveness), the Commissioner will enter an order denying the hearing and stating the final findings and conclusions. (3) If the Commissioner determines upon review of the data and information submitted in the objections and request for a hearing that a hearing is justified, the Commissioner will publish a notice setting forth the following: (i) The regulation or order that is the subject of the hearing; (ii) A statement specifying any part of the regulation or order that has been stayed by operation of law or in the Commissioner's discretion; (iii) The parties to the hearing; (iv) The specific issues of fact for resolution at the hearing; (v) The presiding officer, or a statement that the presiding officer will be designated in a later notice; and (vi) The date, time, and place of the prehearing conference, or a statement that the date, time, and place will be announced in a later notice. However, in the case of a denial of approval, the hearing must not occur more than 90 days after expiration of the 30-day time period in which to request a hearing, unless the presiding officer and the applicant otherwise agree; and in the case of withdrawal of approval, the hearing will occur as soon as practicable. (d) The hearing will be open to the public; however, if the Commissioner finds that portions of the application which serve as a basis for the hearing contain information concerning a method or process entitled to protection as a trade secret, the part of the hearing involving such portions will not be public, unless the respondent so specifies in the request for a hearing. Dated: August 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18809 Filed 8-10-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Rules and Regulations 52995
effective date for a proposed ban.1 to§ 895.30(c) is merely technical, ■ b. In paragraph (b)(2), add an entry in
However, the SMDA did not eliminate insignificant in nature and impact, and numerical sequence for ‘‘§ 895.30(c),
the informal hearing provision for a inconsequential to industry and the regarding a proposed regulation to ban
proposed ban issued with a special public. See Mack Trucks, Inc. v. EPA, a medical device with a special effective
effective date. Thus, section 516(b) of 682 F.3d 87, 94 (D.C. Cir. 2012). This is date.’’
the FD&C Act continues to require that because this correction in no way Dated: August 3, 2016.
FDA ‘‘provide reasonable opportunity changes when FDA is required to Leslie Kux,
for an informal hearing’’ on a proposed provide an opportunity for a hearing,
Associate Commissioner for Policy.
ban with a special effective date (21 which is determined by section 516 of
[FR Doc. 2016–18787 Filed 8–10–16; 8:45 am]
U.S.C. 360f(b)) while subsection (a), the the FD&C Act and part 895, nor does it
general rule for medical device bans, impact the availability of such a hearing BILLING CODE 4164–01–P
does not (see 21 U.S.C. 360f(a)). to any entity impacted by the proposed
On December 10, 1992 (57 FR 58400), ban. It merely corrects a citation error to
avoid confusion. This amendment to DEPARTMENT OF HEALTH AND
FDA published a final rule
§ 16.1(b) thus merely corrects the HUMAN SERVICES
implementing the SMDA. The final rule
of 1992 amended § 895.21(d), which references to the applicable Food and Drug Administration
covers the procedures for issuing a ban requirements of the FD&C Act and its
without a special effective date, by implementing regulations, making 21 CFR Part 514
removing the requirement that FDA notice-and-comment procedures
provide an opportunity for an informal unnecessary in this case. Therefore,
[Docket No. FDA–2016–N–1943]
hearing when there is no special publication of this document constitutes
effective date.2 FDA incorrectly final action on this change under the New Animal Drug Applications;
removed the same language from Administrative Procedure Act (APA) (5 Contents of Notice of Opportunity for
§ 895.30, which covers the procedures U.S.C. 553). a Hearing; Correction
for issuing bans with special effective In addition, FDA finds good cause for
dates; the Agency issued a technical this amendment to become effective on AGENCY: Food and Drug Administration,
amendment restoring this language in the date of publication of this action. HHS.
the Federal Register of June 2, 2015 (80 The APA allows an effective date less Final rule; correcting
ACTION:
FR 31299). However, FDA did not than 30 days after publication as amendments.
correct the language in § 16.1 to list ‘‘provided by the agency for good cause
section 516(b) of the FD&C Act and found and published with the rule’’ (5 SUMMARY: The Food and Drug
§ 895.30(c) as the provisions that U.S.C. 553(d)(3)). A delayed effective Administration (FDA, the Agency, or
provide for regulatory (informal) date is unnecessary in this case because we) is making technical corrections to
hearings, nor did the Agency remove the the amendment to § 16.1 does not its regulations for hearing procedures
reference to § 895.21(d). FDA does so impose any new regulatory for denial of approval or withdrawal of
now. requirements on affected parties. As a approval of new animal drug
FDA finds good cause for issuing this result, affected parties do not need time applications. The Agency is taking this
amendment to § 16.1(b)(1) as a final rule to prepare before the rule takes effect. action to harmonize terminology and to
without notice and comment because Therefore, FDA finds good cause for this improve the organization and clarity of
this amendment corrects the regulations correction to become effective on the the regulations.
to restate the statute (5 U.S.C. 553(b)(B)). date of publication of this action. DATES: This rule is effective August 11,
‘‘[W]hen regulations merely restate the List of Subjects in 21 CFR Part 16 2016.
statute they implement, notice-and-
Administrative practice and ADDRESSES: For access to the docket to
comment procedures are unnecessary.’’
procedure. read background documents or
Gray Panthers Advocacy Committee v.
Therefore, under the Federal Food, comments received, go to http://
Sullivan, 936 F.2d 1284, 1291 (D.C. Cir.
Drug, and Cosmetic Act and under www.regulations.gov and insert the
1991); see also Komjathy v. Nat. Trans.
authority delegated to the Commissioner docket number found in brackets in the
Safety Bd., 832 F.2d 1294, 1296 (D.C.
of Food and Drugs, 21 CFR part 16 is heading of this final rule into the
Cir. 1987) (when a rule ‘‘does no more
amended as follows: ‘‘Search’’ box and follow the prompts,
than repeat, virtually verbatim, the
and/or go to the Division of Dockets
statutory grant of authority,’’ notice-and- PART 16—REGULATORY HEARING Management, 5630 Fishers Lane, Rm.
comment procedures are not required). BEFORE THE FOOD AND DRUG 1061, Rockville, MD 20852.
Further, the change to remove the ADMINISTRATION
erroneous cross-reference to § 895.21(d) FOR FURTHER INFORMATION CONTACT:
and add the correct cross-reference ■ 1. The authority citation for part 16 Vernon Toelle, Center for Veterinary
continues to read as follows: Medicine (HFV–234), Food and Drug
1 Specifically, the SMDA deleted the then-last Administration, 7519 Standish Pl.,
sentence of section 516(a). See Public Law 101–629, Authority: 15 U.S.C. 1451–1461; 21 U.S.C. Rockville, MD 20855, 240–402–5637,
section 18(d)(2) (‘‘Section 516(a) (21 U.S.C. 360f(a)) 141–149, 321–394, 467f, 679, 821, 1034; 28 vernon.toelle@fda.hhs.gov.
is amended . . . by striking out the last sentence.’’); U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.
21 U.S.C. 360f(a) (1989) (stating, in the last SUPPLEMENTARY INFORMATION:
■ 2. Amend § 16.1 as follows:
sentence, ‘‘The Secretary shall afford all interested ■ a. In paragraph (b)(1), remove from the Table of Contents
sradovich on DSK3GMQ082PROD with RULES
persons opportunity for an informal hearing on a
regulation proposed under this subsection.’’). list the entry ‘‘Section 516 of the act
relating to a proposed banned device I. Background
2 Although the hearing provision was validly
II. Legal Authority
removed from § 895.21(d)(8) in 1992, the removed regulations (see § 895.21(d) of this III. Effective Date
language erroneously reappeared in the Code of chapter).’’ and add in its place ‘‘Section
Federal Regulations beginning in 1994. On March IV. Economic Analysis of Impacts
5, 2015 (80 FR 11865), the Office of the Federal
516(b) of the act regarding a proposed V. Analysis of Environmental Impact
Register published a correction document fixing regulation to ban a medical device with VI. Paperwork Reduction Act of 1995
this publication error. a special effective date.’’ VII. Federalism
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![Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Rules and Regulations 52997
regulatory action as defined by List of Subjects in 21 CFR Part 514 (2) If the Commissioner determines
Executive Order 12866. Administrative practice and upon review of the data and information
The Regulatory Flexibility Act procedure, Animal drugs, Confidential submitted in the objections and request
requires us to analyze regulatory options business information, Reporting and for a hearing that a hearing is not
that would minimize any significant recordkeeping requirements. justified because no genuine and
impact of a rule on small entities. Therefore, under the Federal Food, substantial issue of fact precludes the
Because this rule is making only Drug, and Cosmetic Act and under refusal to approve the application or the
technical amendments, we certify that withdrawal of approval of the
authority delegated to the Commissioner
the final rule will not have a significant application (for example, the applicant
of Food and Drugs, 21 CFR part 514 is
economic impact on a substantial has not identified any adequate and
amended as follows:
number of small entities. well-controlled clinical investigations to
The Unfunded Mandates Reform Act PART 514—NEW ANIMAL DRUG support the claims of effectiveness), the
of 1995 (section 202(a)) requires us to APPLICATIONS Commissioner will enter an order
prepare a written statement, which denying the hearing and stating the final
includes an assessment of anticipated ■ 1. The authority citation for part 514 findings and conclusions.
costs and benefits, before issuing ‘‘any continues to read:
rule that includes any Federal mandate (3) If the Commissioner determines
Authority: 21 U.S.C. 321, 331, 351, 352, upon review of the data and information
that may result in the expenditure by 354, 356a, 360b, 371, 379e, 381.
State, local, and tribal governments, in submitted in the objections and request
the aggregate, or by the private sector, of ■ 2. Revise § 514.200 to read as follows: for a hearing that a hearing is justified,
$100,000,000 or more (adjusted the Commissioner will publish a notice
§ 514.200 Notice of opportunity for setting forth the following:
annually for inflation) in any one year.’’ hearing; notice of participation and
The current threshold after adjustment requests for hearing; grant or denial of (i) The regulation or order that is the
for inflation is $146 million, using the hearing. subject of the hearing;
most current (2015) Implicit Price (a) The notice to the applicant of (ii) A statement specifying any part of
Deflator for the Gross Domestic Product. opportunity for a hearing on a proposal the regulation or order that has been
This final rule would not result in an by the Commissioner to refuse to stayed by operation of law or in the
expenditure in any year that meets or approve an application or to withdraw Commissioner’s discretion;
exceeds this amount. the approval of an application will be (iii) The parties to the hearing;
V. Analysis of Environmental Impact published in the Federal Register
together with an explanation of the (iv) The specific issues of fact for
We have determined under 21 CFR resolution at the hearing;
grounds for the proposed action. The
25.31(i) that this action is of a type that
does not individually or cumulatively notice will describe how to request a (v) The presiding officer, or a
have a significant effect on the human hearing. An applicant has 30 days after statement that the presiding officer will
environment. Therefore, neither an publication of the notice to request a be designated in a later notice; and
environmental assessment nor an hearing.
(vi) The date, time, and place of the
environmental impact statement is (b) If the applicant fails to request a
prehearing conference, or a statement
required. hearing within the 30-day timeframe,
that the date, time, and place will be
the Commissioner, without further
VI. Paperwork Reduction Act of 1995 announced in a later notice. However,
notice, will publish a final order
in the case of a denial of approval, the
This final rule contains no collection denying or withdrawing approval of the
hearing must not occur more than 90
of information. Therefore, FDA is not application.
days after expiration of the 30-day time
required to seek clearance by the Office (c) If the applicant desires to request
period in which to request a hearing,
of Management and Budget under the a hearing:
unless the presiding officer and the
Paperwork Reduction Act of 1995 (44 (1) Within 30 days after publication of
applicant otherwise agree; and in the
U.S.C. 3501–3520). the notice of opportunity for hearing,
case of withdrawal of approval, the
the applicant must submit to the
VII. Federalism hearing will occur as soon as
Division of Dockets Management
practicable.
We have analyzed this final rule in written objections and a request for a
accordance with the principles set forth hearing in accordance with §§ 12.20 and (d) The hearing will be open to the
in Executive Order 13132. FDA has 12.22. This request for a hearing must public; however, if the Commissioner
determined that the rule does not include each specific objection to the finds that portions of the application
contain policies that have substantial proposal on which a hearing is which serve as a basis for the hearing
direct effects on the States, on the requested, together with a detailed contain information concerning a
relationship between the National description and analysis of the factual method or process entitled to protection
Government and the States, or on the information (including all relevant as a trade secret, the part of the hearing
distribution of power and clinical and other investigational data) involving such portions will not be
responsibilities among the various the applicant will present in support of public, unless the respondent so
levels of government. Accordingly, we that objection. A request for a hearing specifies in the request for a hearing.
conclude that the rule does not contain may not rest upon mere allegations or Dated: August 3, 2016.
sradovich on DSK3GMQ082PROD with RULES
policies that have federalism denials or general descriptions of
Leslie Kux,
implications as defined in the Executive positions or contentions, but must set
order and, consequently, a federalism forth specific reliable evidence showing Associate Commissioner for Policy.
summary impact statement is not there is a genuine and substantial issue [FR Doc. 2016–18809 Filed 8–10–16; 8:45 am]
required. of fact that requires a hearing. BILLING CODE 4164–01–P
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Document Created: 2018-02-09 11:27:37
Document Modified: 2018-02-09 11:27:37
| 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; correcting amendments. | |
| Dates | This rule is effective August 11, 2016. | |
| Contact | Vernon Toelle, Center for Veterinary Medicine (HFV-234), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5637, [email protected] | |
| FR Citation | 81 FR 52995 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Confidential Business Information and Reporting and Recordkeeping Requirements |
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