82 FR 61443 - New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 248 (December 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 248 (December 28, 2017)
| Page Range | 61443-61446 | |
| FR Document | 2017-27973 |
[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)] [Rules and Regulations] [Pages 61443-61446] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27973] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 511 [Docket No. FDA-2011-N-0079] RIN 0910-AH64 New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA. DATES: This rule is effective January 29, 2018. ADDRESSES: For access to the docket to read background documents or comments received, go to https://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, [[Page 61444]] and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5637, [email protected]. SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Background A. Need for the Regulation B. Summary of Comments to the Proposed Rule III. Legal Authority IV. Comments on the Proposed Rule and FDA Response V. Effective Date VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism I. Executive Summary A. Purpose of the Final Rule The regulations in Sec. 511.1(c) (21 CFR 511.1(c)) provide that a disqualified clinical investigator is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. However, the animal drug regulations permit the same clinical investigator to conduct both nonclinical laboratory studies as well as clinical investigations. We have proposed changes to these regulations (81 FR 57812, August 24, 2016) that would prevent disqualified clinical investigators from conducting nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug, thus enhancing protection of animal research subjects and ensuring the quality and integrity of data submitted to FDA in support of a new animal drug approval. B. Summary of the Major Provisions of the Final Rule This final rule expands the clinical investigator disqualification regulations in Sec. 511.1(c) to include the ineligibility of a disqualified investigator to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. We received one comment, and it supported the proposed amendment. C. Legal Authority FDA is issuing these regulations based on its authority under the new animal drug provisions in section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) and under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act. D. Costs and Benefits FDA believes this final rule is not a significant regulatory action as defined by Executive Order 12866 and certifies that it will not have a significant economic impact on a substantial number of small entities. FDA and applicants will not incur additional costs by expanding the scope in part 511 for disqualification of a clinical investigator. The benefit of preventing a disqualified clinical investigator from performing both nonclinical laboratory studies as well as clinical investigations will be enhanced protection of animal research subjects and data integrity submitted to FDA in support of a new animal drug approval. II. Background FDA may consider disqualification of a clinical investigator when FDA has information that an investigator has repeatedly or deliberately failed to comply with applicable requirements for the conduct of clinical investigations, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report. Disqualification of an investigator is initiated by the appropriate FDA center depending upon the particular type of test article (e.g., new animal drug for investigational use) under study by the investigator in the clinical investigation. For example, the Center for Veterinary Medicine (CVM or the Center) may pursue disqualification of a clinical investigator who conducted a new animal drug clinical investigation and allegedly submitted to FDA or the sponsor false information in a required report. The regulations provide the investigator who is subject to disqualification an opportunity to be heard and explain the matter complained of, i.e., explain the alleged violations. If the explanation offered is not accepted by the Center, the investigator will be given an opportunity for an informal regulatory hearing under part 16 (21 CFR part 16). After evaluating all available information, including any explanation presented by the investigator, the Commissioner issues a Commissioner's decision regarding the eligibility of the investigator to receive a particular type of test article (e.g., a new animal drug for investigational use). When disqualified by a Commissioner's decision, the investigator is no longer eligible to receive the particular type of test article under study when the violations occurred (e.g., new animal drugs). Also, an investigator disqualified by a Commissioner's decision is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Because CVM regulates drugs for animal use, the study subjects are animals in both clinical investigations and nonclinical laboratory studies intended to support the approval of a new animal drug. Nonclinical laboratory studies such as those for target animal safety and human food safety may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. For animal drug products regulated by CVM, the same investigator may conduct both clinical investigations and nonclinical laboratory studies. For example, CVM's two most recent clinical investigator disqualification matters involved investigators who were also study directors on nonclinical laboratory studies submitted to CVM in support of applications for a new animal drug. In addition, CVM is aware of multiple persons who conduct both clinical investigations and nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. Therefore, CVM proposed (81 FR 57812) that it have authority to disqualify an investigator from conducting nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug when that same investigator is disqualified from conducting clinical investigations. A. Need for the Regulation Expanding the regulations to include that a disqualified investigator is ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug helps to ensure adequate protection of animal research subjects and data integrity. This action also leads to improved public confidence in the nonclinical and clinical data supporting FDA decisions for new animal drug approvals. [[Page 61445]] B. Summary of Comments to the Proposed Rule We received one comment to the proposed rule. The comment supports the proposal. Therefore, we are finalizing the proposal without revision. III. Legal Authority We are issuing this final rule under section 512(j) of the FD&C Act, which authorizes FDA to issue regulations for exempting from the operation of section 512 of the FD&C Act new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs, and section 701(a) of the FD&C Act, which authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. An investigator who repeatedly or deliberately submits to FDA or the sponsor false information in a required report would not be considered a qualified expert with the experience required to conduct nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. FDA therefore concludes that legal authority to promulgate this rule exists under sections 512(j) and 701(a) of the FD&C Act, as essential to protection of the public health and safety and to enforcement of the Agency's responsibilities under sections 201, 501, 502, 503, 512, and 701 of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 360b, and 371). IV. Comments on the Proposed Rule and FDA Response We received no adverse or substantive comment and are finalizing without change. V. Effective Date This rule is effective January 29, 2018. VI. Economic Analysis of Impacts We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, 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). Executive Order 13771 requires that the costs associated with significant new regulations ``shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.'' 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 this rule does not impose new requirements on any entity and therefore has no associated compliance costs, 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 $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This final rule will not result in an expenditure in any year that meets or exceeds this amount. This rule expands the scope in part 511 of disqualification of a clinical investigator to include ineligibility to conduct nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. A final rule published on April 30, 2012 (77 FR 25353), prevents a disqualified investigator from conducting any clinical investigation, and therefore applies explicitly to clinical investigations. However, that rule was silent on nonclinical laboratory studies. Thus, before this final rule, a disqualified investigator could conduct a nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. Because the reason for disqualification in part 511 is typically the repeated or deliberate submission of false information to us or to sponsors in a required report, preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is essential to adequate protection of animal research subjects and data integrity. We will not incur additional costs by expanding the scope in part 511 for disqualification of a clinical investigator because we already post the names of any disqualified investigator on FDA's internet site at https://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings&previewMode=true&displayAll=true. Similarly, industry will not incur additional costs because the rule does not require applicants to perform additional tasks. For instance, upon disqualification, we post the respective investigator's name on FDA's internet site, which helps mitigate the employment of a disqualified investigator for clinical investigations or nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. The benefit of preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations will be enhanced protection of animal research subjects and data integrity. VII. Analysis of Environmental Impact We have 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. VIII. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. IX. 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 21 CFR Part 16 Administrative practice and procedure. 21 CFR Part 511 Animal drugs, Medical research, Reporting and recordkeeping requirements. [[Page 61446]] Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 16 and 511 are amended as follows: PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION 0 1. The authority citation for part 16 continues to read as follows: Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364. 0 2. In Sec. 16.1, in paragraph (b)(2), revise the numerically sequenced entry for Sec. 511.1(c)(1) to read as follows: Sec. 16.1 Scope. * * * * * (b) * * * (2) * * * (c)(1), relating to whether an investigator is eligible to receive test articles under part 511 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. * * * * * PART 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE 0 3. The authority citation for part 511 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371. 0 4. In Sec. 511.1: 0 a. Revise the section heading; 0 b. Revise the last sentence in paragraph (c)(1); 0 c. Add paragraphs (c)(1)(i) and (ii); 0 d. Revise the last sentence in paragraph (c)(2); 0 e. Add paragraphs (c)(2)(i) and (ii); and 0 f. Revise paragraph (c)(6). The revisions and additions read as follows: Sec. 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act. * * * * * (c) * * * (1) * * * If an explanation is offered but not accepted by the Center for Veterinary Medicine, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct: (i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA; and (ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. (2) * * * The notification also will explain that an investigator determined to be ineligible to receive test articles under this part will be ineligible to conduct: (i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and (ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. * * * * * (6) An investigator who has been determined to be ineligible under paragraph (c)(2) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug, solely in compliance with the applicable provisions of this chapter. * * * * * Dated: December 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27973 Filed 12-27-17; 8:45 am] BILLING CODE 4164-01-P
![61443
Rules and Regulations Federal Register
Vol. 82, No. 248
Thursday, December 28, 2017
This section of the FEDERAL REGISTER Greg Feder, Counsel, gfeder@fdic.gov, or § 382.2 [Amended]
contains regulatory documents having general Francis Kuo, Counsel, fkuo@fdic.gov, ■ 5. In § 382.2, amend paragraph
applicability and legal effect, most of which Legal Division, Federal Deposit (c)(1)(ii) by removing ‘‘January 19,
are keyed to and codified in the Code of Insurance Corporation, 550 17th Street
Federal Regulations, which is published under 2019’’ and adding ‘‘January 1, 2019’’ in
NW, Washington, DC 20429. its place.
50 titles pursuant to 44 U.S.C. 1510.
SUPPLEMENTARY INFORMATION: We are Dated at Washington, DC, on December 21,
The Code of Federal Regulations is sold by making technical corrections to 12 CFR 2017.
the Superintendent of Documents. 329.3 and 382.2. We are also making Federal Deposit Insurance Corporation.
effective amendatory instruction #6, Valerie J. Best,
published in the final rule on October Assistant Executive Secretary.
FEDERAL DEPOSIT INSURANCE
30, 2017, at 82 FR 50228.
CORPORATION [FR Doc. 2017–27971 Filed 12–27–17; 8:45 am]
List of Subjects BILLING CODE 6714–01–P
12 CFR Parts 324, 329, and 382
12 CFR Part 329
RIN 3064–AE46
Administrative practice and DEPARTMENT OF HEALTH AND
Restrictions on Qualified Financial procedure, Banks, banking, Federal HUMAN SERVICES
Contracts of Certain FDIC-Supervised Deposit Insurance Corporation, FDIC,
Institutions; Revisions to the Definition Liquidity, Reporting and recordkeeping Food and Drug Administration
of Qualifying Master Netting requirements.
Agreement and Related Definitions 21 CFR Parts 16 and 511
12 CFR Part 382
AGENCY: Federal Deposit Insurance [Docket No. FDA–2011–N–0079]
Administrative practice and
Corporation (FDIC).
procedure, Banks, banking, Federal RIN 0910–AH64
ACTION: Final rule; technical correction; Deposit Insurance Corporation, FDIC,
confirmation of effective date. Qualified financial contracts, Reporting New Animal Drugs for Investigational
and recordkeeping requirements, State Use; Disqualification of a Clinical
SUMMARY: This document makes
savings associations, State non-member Investigator
technical corrections to regulations that
were published in the Federal Register banks. AGENCY: Food and Drug Administration,
on October 30, 2017. The FDIC added For the reasons stated in the HHS.
Part 382 to its regulations to improve supplementary information, the Federal ACTION: Final rule.
the resolvability of systemically Deposit Insurance Corporation amends
important U.S. banking organizations 12 CFR chapter III as follows: SUMMARY: The Food and Drug
and systemically important foreign Administration (FDA, the Agency, or
banking organizations and enhance the PART 329—LIQUIDITY RISK we) is issuing a final rule amending the
resilience and the safety and soundness MEASUREMENT STANDARDS regulations for new animal drugs for
of certain State savings associations and investigational use to expand the scope
State-chartered banks and made certain ■ 1. The authority citation for part 329 of clinical investigator disqualification
conforming changes to Part 329. This continues to read as follows: to include ineligibility to conduct
document is being published to make Authority: 12 U.S.C. 1815, 1816, 1818, nonclinical laboratory studies. Under
technical corrections to certain rules 1819, 1828, 1831p–1, 5412. this final rule, when the Commissioner
under Parts 329 and 382 and make of Food and Drugs (the Commissioner)
effective amendatory instruction 6 in § 329.3 [Amended] determines that an investigator is
the previously published regulation. ■ 2. In § 329.3, amend paragraph ineligible to receive a new animal drug
DATES: Effective January 1, 2018. (2)(i)(A) of the definition of ‘‘Qualifying for investigational use, the investigator
Amendatory instruction 6 in the final master netting agreement’’ by adding also will be ineligible to conduct any
rule published October 30, 2017, at 82 ‘‘or’’ following the semi-colon. nonclinical study intended to support
FR 50228, is effective January 1, 2018. an application for a research or
FOR FURTHER INFORMATION CONTACT: PART 382—RESTRICTIONS ON marketing permit for a new animal drug.
Ryan Billingsley, Acting Associate QUALIFIED FINANCIAL CONTRACTS This final rule will help ensure
Director, Capital Markets Branch, adequate protection of animal research
Division of Risk Management and ■ 3. The authority citation for part 382 subjects and the quality and integrity of
Supervision, rbillingsley@fdic.gov; continues to read as follows: data submitted to FDA.
Alexandra Steinberg Barrage, Senior Authority: 12 U.S.C. 1816, 1818, 1819, DATES: This rule is effective January 29,
Resolution Policy Specialist, Office of 1820(g), 1828, 1828(m), 1831n, 1831o, 2018.
sradovich on DSK3GMQ082PROD with RULES
Complex Financial Institutions, 1831p–l, 1831(u), 1831w. ADDRESSES: For access to the docket to
abarrage@fdic.gov; David N. Wall, read background documents or
§ 382.1 [Amended]
Assistant General Counsel, dwall@ comments received, go to https://
fdic.gov, Cristina Regojo, Counsel, ■ 4. As of January 1, 2018, make www.regulations.gov and insert the
cregojo@fdic.gov, Phillip Sloan, effective amendatory instruction #6 as docket number found in brackets in the
Counsel, psloan@fdic.gov, Michael published October 30, 2017, at 82 FR heading of this final rule into the
Phillips, Counsel, mphillips@fdic.gov, 50228. ‘‘Search’’ box and follow the prompts,
VerDate Sep<11>2014 16:07 Dec 27, 2017 Jkt 244001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1](https://thefederalregister.org/doc/82_FR_61691/page/1.svg)
![61446 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Rules and Regulations
Therefore, under the Federal Food, Veterinary Medicine, the investigator DEPARTMENT OF HEALTH AND
Drug, and Cosmetic Act and under will be given an opportunity for a HUMAN SERVICES
authority delegated to the Commissioner regulatory hearing under part 16 of this
of Food and Drugs, 21 CFR parts 16 and chapter on the question of whether the Food and Drug Administration
511 are amended as follows: investigator is eligible to receive test
articles under this part and eligible to 21 CFR Part 884
PART 16—REGULATORY HEARING conduct: [Docket No. FDA–2017–N–6842]
BEFORE THE FOOD AND DRUG
ADMINISTRATION (i) Any clinical investigation that
supports an application for a research or Medical Devices; Obstetrical and
1. The authority citation for part 16 Gynecological Devices; Classification
■ marketing permit for products regulated
continues to read as follows: of the Pressure Wedge for the
by FDA; and
Reduction of Cesarean Delivery
Authority: 15 U.S.C. 1451–1461; 21 U.S.C. (ii) Any nonclinical laboratory study
141–149, 321–394, 467f, 679, 821, 1034; 28 intended to support an application for a AGENCY: Food and Drug Administration,
U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. HHS.
research or marketing permit for a new
■ 2. In § 16.1, in paragraph (b)(2), revise animal drug. ACTION: Final order.
the numerically sequenced entry for (2) * * * The notification also will
§ 511.1(c)(1) to read as follows: SUMMARY: The Food and Drug
explain that an investigator determined Administration (FDA or we) is
§ 16.1 Scope. to be ineligible to receive test articles classifying the pressure wedge for the
* * * * * under this part will be ineligible to reduction of cesarean delivery into class
(b) * * * conduct: II (special controls). The special controls
(2) * * * (i) Any clinical investigation that that apply to the device type are
(c)(1), relating to whether an supports an application for a research or identified in this order and will be part
investigator is eligible to receive test marketing permit for products regulated of the codified language for the pressure
articles under part 511 of this chapter by FDA, including drugs, biologics, wedge for the reduction of cesarean
and eligible to conduct any clinical devices, new animal drugs, foods, delivery’s classification. We are taking
investigation that supports an including dietary supplements, that bear this action because we have determined
application for a research or marketing that classifying the device into class II
a nutrient content claim or a health
permit for products regulated by FDA (special controls) will provide a
claim, infant formulas, food and color
including drugs, biologics, devices, new reasonable assurance of safety and
animal drugs, foods, including dietary additives, and tobacco products; and effectiveness of the device. We believe
supplements, that bear a nutrient (ii) Any nonclinical laboratory study this action will also enhance patients’
content claim or a health claim, infant intended to support an application for a access to beneficial innovative devices,
formulas, food and color additives, and research or marketing permit for a new in part by reducing regulatory burdens.
tobacco products; and any nonclinical animal drug. DATES: This order is effective December
laboratory study intended to support an * * * * * 28, 2017. The classification was
application for a research or marketing applicable on December 19, 2016.
permit for a new animal drug. (6) An investigator who has been
determined to be ineligible under FOR FURTHER INFORMATION CONTACT:
* * * * * Mack Hall III, Center for Devices and
paragraph (c)(2) of this section may be
reinstated as eligible when the Radiological Health, Food and Drug
PART 511—NEW ANIMAL DRUGS FOR Administration, 10903 New Hampshire
INVESTIGATIONAL USE Commissioner determines that the
investigator has presented adequate Ave., Bldg. 66, Rm. 3572, Silver Spring,
■ 3. The authority citation for part 511 assurances that the investigator will MD 20993–0002, 301–796–5621,
continues to read as follows: mack.hall@fda.hhs.gov.
employ all test articles, and will
conduct any clinical investigation that SUPPLEMENTARY INFORMATION:
Authority: 21 U.S.C. 321, 351, 352, 353,
360b, 371. supports an application for a research or I. Background
■ 4. In § 511.1: marketing permit for products regulated
Upon request, FDA has classified the
■ a. Revise the section heading; by FDA and any nonclinical laboratory
pressure wedge for the reduction of
■ b. Revise the last sentence in study intended to support an cesarean delivery as class II (special
paragraph (c)(1); application for a research or marketing controls), which we have determined
■ c. Add paragraphs (c)(1)(i) and (ii); permit for a new animal drug, solely in will provide a reasonable assurance of
■ d. Revise the last sentence in compliance with the applicable safety and effectiveness. In addition, we
paragraph (c)(2); provisions of this chapter. believe this action will enhance
■ e. Add paragraphs (c)(2)(i) and (ii);
* * * * * patients’ access to beneficial innovation,
and in part by reducing regulatory burdens
■ f. Revise paragraph (c)(6). Dated: December 21, 2017.
by placing the device into a lower
The revisions and additions read as Leslie Kux,
device class than the automatic class III
follows: Associate Commissioner for Policy. assignment.
§ 511.1 New animal drugs for [FR Doc. 2017–27973 Filed 12–27–17; 8:45 am] The automatic assignment of class III
sradovich on DSK3GMQ082PROD with RULES
investigational use exempt from section BILLING CODE 4164–01–P occurs by operation of law and without
512(a) of the Federal Food, Drug, and any action by FDA, regardless of the
Cosmetic Act. level of risk posed by the new device.
* * * * * Any device that was not in commercial
(c) * * * distribution before May 28, 1976, is
(1) * * * If an explanation is offered automatically classified as, and remains
but not accepted by the Center for within, class III and requires premarket
VerDate Sep<11>2014 16:07 Dec 27, 2017 Jkt 244001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1](https://thefederalregister.org/doc/82_FR_61691/page/4.svg)
Document Created: 2017-12-28 00:44:05
Document Modified: 2017-12-28 00:44:05
| 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 29, 2018. | |
| Contact | Vernon Toelle, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5637, [email protected] | |
| FR Citation | 82 FR 61443 | |
| RIN Number | 0910-AH64 | |
| CFR Citation | 21
CFR
16 21 CFR 511 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Medical Research and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR