Administrative Actions for Noncompliance; Lesser Administrative Actions, 19033-19036 [2016-07523]

Download as PDF Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations Regulatory Flexibility Act We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it applies to individuals only. Thus, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended. Paperwork Reduction Act These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act. (Catalog of Federal Domestic Assistance Program No. 96.006, Supplemental Security Income.) List of Subjects in 20 CFR Part 404 Administrative practice and procedure; Blind; Disability benefits; Government employees; Old-age, Survivors and Disability Insurance; Reporting and recordkeeping requirements; Social security. 4. In § 404.401, revise paragraph (a)(4) to read as follows: ADDRESSES: § 404.401 Deduction, reduction, and nonpayment of monthly benefits or lumpsum death payments. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). ■ * * * * * (a) * * * (4) An individual under full retirement age (see § 404.409) is concurrently entitled to disability insurance benefits and to certain public disability benefits (see § 404.408); * * * * * ■ 5. In § 404.408, revise paragraph (a)(2)(ii) to read as follows: § 404.408 Reduction of benefits based on disability on account of receipt of certain other disability benefits provided under Federal, State, or local laws or plans. * * * * * (a) * * * (2) * * * (ii) The individual has not attained full retirement age as defined in § 404.409. * * * * * Dated: March 25, 2016. Carolyn W. Colvin, Acting Commissioner of Social Security. [FR Doc. 2016–07602 Filed 4–1–16; 8:45 am] BILLING CODE 4191–02–P For the reasons set forth in the preamble, we amend subparts D and E of part 404 of title 20 of the Code of Federal Regulations as set forth below: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950– ). 21 CFR Part 56 [Docket No. FDA–2015–N–5052] Subpart D—[Amended] 1. The authority citation for subpart D of part 404 continues to read as follows: ■ Authority: Secs. 202, 203(a) and (b), 205(a), 216, 223, 225, 228(a)–(e), and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 403(a) and (b), 405(a), 416, 423, 425, 428(a)–(e), and 902(a)(5)). 2. Amend § 404.317 by revising the fourth sentence to read as follows: ■ § 404.317 How is the amount of my disability benefit calculated? * * * Your monthly benefit amount may be reduced if you receive workers’ compensation or public disability payments before you attain full retirement age (as defined in § 404.409) (see § 404.408). * * * mstockstill on DSK4VPTVN1PROD with RULES Subpart E—[Amended] 3. The authority citation for subpart E of part 404 continues to read as follows: ■ Authority: Secs. 202, 203, 204(a) and (e), 205(a) and (c), 216(l), 222(c), 223(e), 224, 225, 702(a)(5), and 1129A of the Social Security Act (42 U.S.C. 402, 403, 404(a) and (e), 405(a) and (c), 416(l), 422(c), 423(e), 424a, 425, 902(a)(5), and 1320a–8a); 48 U.S.C. 1801. VerDate Sep<11>2014 17:02 Apr 01, 2016 Jkt 238001 19033 Administrative Actions for Noncompliance; Lesser Administrative Actions AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDAregulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA’s IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations. DATES: This rule is effective August 17, 2016. Submit electronic or written comments on this direct final rule or its companion proposed rule by June 20, 2016. SUMMARY: PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 You may submit comments as follows: Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–N–5052 for ‘‘Subpart E— Administrative Actions for Noncompliance; Lesser Administrative Actions.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper E:\FR\FM\04APR1.SGM 04APR1 19034 Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, 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: Sheila Brown, Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993–0002, 301–796–6563. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with RULES I. Background FDA is amending § 56.120(b) (21 CFR 56.120(b)), which describes lesser administrative actions that the Agency may impose on an IRB until the IRB takes appropriate action to correct the IRB’s noncompliance. We are publishing this direct final rule because it is intended to clarify an existing regulation, and we do not anticipate any significant adverse comment regarding this amendment to § 56.120(b). Specifically, this direct final rule would amend § 56.120(b) by clarifying that FDA has authority to require the IRB to withhold approval of new FDA- VerDate Sep<11>2014 17:02 Apr 01, 2016 Jkt 238001 regulated studies conducted at the institution or reviewed by the IRB, direct that no new subjects be added to ongoing studies, and terminate ongoing studies provided that doing so would not endanger study subjects. This amendment also renumbers current paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and inserts ‘‘FDA may’’ into newly designated paragraph (c) so that it is a complete sentence. FDA first proposed requirements for the composition and operations of institutional review committees in the ‘‘Proposed Investigational Device Exemptions,’’ published in the Federal Register of August 20, 1976 (41 FR 35282; ‘‘Proposed IDE Rule’’). In that document, FDA proposed disqualification procedures for institutional review committees and requested comments on the proposed procedures and other possible administrative actions that FDA might take against a committee that is not in compliance with the regulations (41 FR 35282 at 35293). FDA also stated its intention to publish uniform, Agencywide regulations governing clinical investigations at a later date, including requirements governing institutional review committees (41 FR 35282 at 35283). Subsequently, FDA published ‘‘Standards for Institutional Review Boards for Clinical Investigations’’ on August 8, 1978 (43 FR 35186; ‘‘Proposed IRB Standards’’). Comments on implementing institutional review requirements received in response to the Proposed IDE Rule were reviewed and utilized in preparing the Proposed IRB Standards (43 FR 35186 at 35187). In the Proposed IRB Standards, FDA proposed that disqualification would be used only if the Commissioner of Food and Drugs finds that: (1) The IRB failed to comply with one or more of the standards for IRBs in part 56 or other supplemental requirements in the investigational new drug or investigational device exemptions (IDE) regulations; (2) the noncompliance adversely affects the validity of the data or the rights or safety of the human subjects; and (3) other lesser regulatory actions (e.g., warnings or rejection of data from individual clinical investigations) have not been or probably will not be adequate in achieving compliance (43 FR 35186 at 35195). FDA received numerous comments to the Proposed IRB Standards, and addressed those comments in the Federal Register of January 27, 1981 (46 FR 8958), ‘‘Protection of Human Subjects: Standards for Institutional Review Boards for Clinical PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 Investigations, Final Rule.’’ Specifically, several comments suggested that any lesser regulatory actions should be listed (46 FR 8958 at 8973). FDA accepted these comments and revised § 56.120(b) to set forth the lesser administrative actions that the Agency may take if FDA finds deficiencies in the operation of an IRB and to describe the circumstances in which these lesser administrative actions may be used by the Agency. FDA’s longstanding interpretation of § 56.120(b) is that FDA may impose these restrictions on a noncompliant IRB until the IRB takes appropriate corrective action. The text of the regulation, however, suggests that it is the Agency that would withhold approval of studies that have been reviewed by a noncompliant IRB, rather than authorizing FDA to direct the IRB to stop approving new studies until the IRB comes back into compliance. This direct final rule amends § 56.120(b) to read, in addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to withhold approval of new studies, direct that no new subjects be added to ongoing studies, or terminate ongoing studies. This will ensure that those activities are suspended until the IRB takes appropriate corrective action to address its noncompliance. We believe revising § 56.120(b) as described in this document will improve the clarity and accuracy of the regulations. We are also renumbering § 56.120(b)(4) as § 56.120(c), and § 56.120(c) as § 56.120(d). We are inserting ‘‘FDA may’’ into newly designated § 56.120(c) so that it is a complete sentence. FDA may notify relevant State and Federal regulatory Agencies when warranted to assure that organizations with a need to know about the IRB’s apparent noncompliance are appropriately informed. The revision would eliminate confusion by stating clearly that FDA is authorized to notify others about the IRB’s noncompliance. We believe these changes will ensure clarity and improve the accuracy of the regulations. II. Procedures for Issuing a Direct Final Rule In the Federal Register of November 21, 1997 (62 FR 62466), FDA announced the availability of the guidance document entitled ‘‘Guidance for FDA and Industry: Direct Final Rule Procedures’’ 1 that described when and how we will employ direct final rulemaking. We believe that this rule is 1 https://www.fda.gov/regulatoryinformation/ guidances/ucm125166.htm. E:\FR\FM\04APR1.SGM 04APR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations appropriate for direct final rulemaking because it is intended to clarify an existing regulation. We anticipate no significant adverse comment. Consistent with FDA’s direct final rulemaking procedures, we are publishing a companion proposed rule elsewhere in this issue of the Federal Register. That proposed rule is identical in substance to this direct final rule. The companion proposed rule will serve the purpose of issuing a proposed rule under usual notice-and-comment procedures in the event we withdraw this direct final rule because we receive significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. We will consider any comments that we receive in response to the companion proposed rule to be comments also regarding this direct final rule and vice versa. If FDA receives any significant adverse comment, we will withdraw this direct final rule before its effective date by publishing a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is one that explains why the rule would be inappropriate (including challenges to the rule’s underlying premise or approach), or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, we consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule would not be considered adverse. A comment recommending a rule change in addition to the rule would not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment. If we withdraw this direct final rule, FDA will consider all comments that we received regarding the companion proposed rule as we develop a final rule through the usual notice-and-comment procedures of the APA. If we receive no significant adverse comment during the specified comment period regarding this direct final rule, we intend to publish a VerDate Sep<11>2014 17:02 Apr 01, 2016 Jkt 238001 confirmation notice in the Federal Register within 30 days after the comment period ends. III. Legal Authority This rule, if finalized, would amend § 56.120(b). FDA’s authority to modify § 56.120(b) arises from the same authority under which FDA initially issued this regulation, the IRB regulations, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c–360f, 360h, 360i, 360j, 360hh–360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262). IV. Analysis of Environmental Impact We have determined under 21 CFR 25.30(h) and 25.34(a) 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. V. Economic Analysis of Impact 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 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 this rule does not add any additional regulatory burdens, we certify that this final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 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 $144 million, using the PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 19035 most current (2014) 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. The purpose of this final rule is to affirm FDA’s longstanding interpretation of § 56.120(b), that FDA may impose these administrative actions on a noncompliant IRB until the IRB takes appropriate corrective action. The amendment will improve the clarity and accuracy of the regulations. Because this final rule is a clarification and would impose no additional regulatory burdens, this regulation is not anticipated to result in any compliance costs, and the economic impact is expected to be minimal. VI. Paperwork Reduction Act of 1995 This direct 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. 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, the Agency has concluded 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 56 Human research subjects, Reporting and recordkeeping requirements, Safety. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 56 is amended as follows: PART 56—INSTITUTIONAL REVIEW BOARDS 1. The authority citation for 21 CFR part 56 is revised to read as follows: ■ Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c–360f, 360h, 360i, 360j, 360hh–360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262. 2. In § 56.120, redesignate paragraphs (b)(4) and (c) as paragraphs (c) and (d), respectively, and revise paragraph (b) and newly designated paragraph (c) to read as follows: ■ E:\FR\FM\04APR1.SGM 04APR1 19036 Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations § 56.120 Lesser administrative actions. * * * * (b) On the basis of the IRB’s or the institution’s response, FDA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB; (2) Direct that no new subjects be added to ongoing studies subject to this part; or (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects. (c) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, FDA may notify relevant State and Federal regulatory agencies and other parties with a direct interest in the Agency’s action of the deficiencies in the operation of the IRB. * * * * * Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–07523 Filed 4–1–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG–2015–1055] RIN 1625–AA08 Special Local Regulation; Charleston Race Week, Charleston Harbor, Charleston, SC Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: The Coast Guard is establishing a special local regulation on the waters of Charleston Harbor in Charleston, SC during the Charleston Race Week from April 15, 2016 through April 17, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative. DATES: This rule is effective from April 15, 2016 through April 17, 2016. mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 17:02 Apr 01, 2016 Jkt 238001 To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2015– 1055 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rule. FOR FURTHER INFORMATION CONTACT: If you have questions about this rule, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone(843)740–3184, email John.Z.Downing@uscg.mil. SUPPLEMENTARY INFORMATION: ADDRESSES: * I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History On November 18, 2015, the Charleston Ocean Racing Association notified the Coast Guard that it will sponsor a series of sailboat races in the Charleston Harbor, Charleston, SC. from 8:30 a.m. to 5 p.m. April 15, 2016 through April 17, 2016. In response, on February 5, 2016, the Coast Guard published a notice of proposed rulemaking titled Charleston Race Week. There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this special local regulation. During the comment period that ended March 7, 2016, we received no comments. Under good cause provisions in 5 U.S.C. 553(d)(3), we are making this rule effective less than 30 days after its publication in the Federal Register. The Coast Guard finds that good cause exists for making this rule effective starting April 15, 2016 because this special local regulation is necessary to ensure the safety of life and property during this high speed boat race and it would be contrary to public interest not to make this rule effective by April 15, 2016. Also, this regulation will have a limited impact on the waterway for a limited time and designated representatives will be on scene to assist the public with compliance. III. Legal Authority and Need for Rule The legal basis for the rule is the Coast Guard’s authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to insure safety of life on navigable waters of the United States during three Charleston Race Week sailboat races. It was determined that potential hazards PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 are associated with the areas used in the Charleston Race Week sailboat races that can be alleviated by prohibiting access to the regulated areas. IV. Discussion of Comments, Changes, and the Rule As noted above, we received no comments on our NPRM published February 5, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM. From April 15, 2016 through April 17, 2016, Charleston Ocean Racing Association will host three sailboat races on Charleston Harbor in Charleston, South Carolina during Charleston Race Week. Approximately 300 sailboats will participate in the three races. This rule establishes a special local regulation on certain waters of Charleston Harbor in Charleston, South Carolina. The special local regulation will be enforced daily from 8:30 a.m. until 5 p.m. on April 15, 2016 through April 17, 2016. The special local regulation consists of the following three race areas. 1. Race Area #1. All waters encompassed within a 700 yard radius of position 32°46′10″ N. 79°55′15″ W. 2. Race Area #2. All waters encompassed within a 700 yard radius of position 32°46′02″ N. 79°54′15″ W. 3. Race Area #3. All waters encompassed within a 700 yard radius of position 32°45′55″ N. 79°53′39″ W. Except for those persons and vessels participating in the sailboat races, persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the race areas unless specifically authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the race areas may contact the Captain of the Port Charleston by telephone at (843) 740–7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the race areas is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives. E:\FR\FM\04APR1.SGM 04APR1

Agencies

[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Rules and Regulations]
[Pages 19033-19036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07523]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 56

[Docket No. FDA-2015-N-5052]

Administrative Actions for Noncompliance; Lesser Administrative
Actions

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation describing lesser administrative actions that may be imposed
on an Institutional Review Board (IRB) that has failed to comply with
FDA's IRB regulations. We are clarifying that FDA may require the IRB
to withhold approval of new FDA-regulated studies, stop the enrollment
of new subjects in ongoing studies, and terminate ongoing studies, or
any combination of these actions until the noncompliance with FDA's IRB
regulations is corrected. We are taking this action to ensure clarity
and improve the accuracy of the regulations.

DATES: This rule is effective August 17, 2016. Submit electronic or
written comments on this direct final rule or its companion proposed
rule by June 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-5052 for ``Subpart E--Administrative Actions for
Noncompliance; Lesser Administrative Actions.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

[[Page 19034]]

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, 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: Sheila Brown, Office of Good Clinical
Practice, Office of Special Medical Programs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20993-0002, 301-796-6563.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is amending Sec. 56.120(b) (21 CFR 56.120(b)), which describes
lesser administrative actions that the Agency may impose on an IRB
until the IRB takes appropriate action to correct the IRB's
noncompliance. We are publishing this direct final rule because it is
intended to clarify an existing regulation, and we do not anticipate
any significant adverse comment regarding this amendment to Sec.
56.120(b). Specifically, this direct final rule would amend Sec.
56.120(b) by clarifying that FDA has authority to require the IRB to
withhold approval of new FDA-regulated studies conducted at the
institution or reviewed by the IRB, direct that no new subjects be
added to ongoing studies, and terminate ongoing studies provided that
doing so would not endanger study subjects.
This amendment also renumbers current paragraphs (b)(4) and (c) as
paragraphs (c) and (d), respectively, and inserts ``FDA may'' into
newly designated paragraph (c) so that it is a complete sentence.
FDA first proposed requirements for the composition and operations
of institutional review committees in the ``Proposed Investigational
Device Exemptions,'' published in the Federal Register of August 20,
1976 (41 FR 35282; ``Proposed IDE Rule''). In that document, FDA
proposed disqualification procedures for institutional review
committees and requested comments on the proposed procedures and other
possible administrative actions that FDA might take against a committee
that is not in compliance with the regulations (41 FR 35282 at 35293).
FDA also stated its intention to publish uniform, Agency-wide
regulations governing clinical investigations at a later date,
including requirements governing institutional review committees (41 FR
35282 at 35283).
Subsequently, FDA published ``Standards for Institutional Review
Boards for Clinical Investigations'' on August 8, 1978 (43 FR 35186;
``Proposed IRB Standards''). Comments on implementing institutional
review requirements received in response to the Proposed IDE Rule were
reviewed and utilized in preparing the Proposed IRB Standards (43 FR
35186 at 35187). In the Proposed IRB Standards, FDA proposed that
disqualification would be used only if the Commissioner of Food and
Drugs finds that: (1) The IRB failed to comply with one or more of the
standards for IRBs in part 56 or other supplemental requirements in the
investigational new drug or investigational device exemptions (IDE)
regulations; (2) the noncompliance adversely affects the validity of
the data or the rights or safety of the human subjects; and (3) other
lesser regulatory actions (e.g., warnings or rejection of data from
individual clinical investigations) have not been or probably will not
be adequate in achieving compliance (43 FR 35186 at 35195).
FDA received numerous comments to the Proposed IRB Standards, and
addressed those comments in the Federal Register of January 27, 1981
(46 FR 8958), ``Protection of Human Subjects: Standards for
Institutional Review Boards for Clinical Investigations, Final Rule.''
Specifically, several comments suggested that any lesser regulatory
actions should be listed (46 FR 8958 at 8973). FDA accepted these
comments and revised Sec. 56.120(b) to set forth the lesser
administrative actions that the Agency may take if FDA finds
deficiencies in the operation of an IRB and to describe the
circumstances in which these lesser administrative actions may be used
by the Agency. FDA's longstanding interpretation of Sec. 56.120(b) is
that FDA may impose these restrictions on a noncompliant IRB until the
IRB takes appropriate corrective action. The text of the regulation,
however, suggests that it is the Agency that would withhold approval of
studies that have been reviewed by a noncompliant IRB, rather than
authorizing FDA to direct the IRB to stop approving new studies until
the IRB comes back into compliance.
This direct final rule amends Sec. 56.120(b) to read, in addition,
until the IRB or the parent institution takes appropriate corrective
action, the Agency may require the IRB to withhold approval of new
studies, direct that no new subjects be added to ongoing studies, or
terminate ongoing studies. This will ensure that those activities are
suspended until the IRB takes appropriate corrective action to address
its noncompliance. We believe revising Sec. 56.120(b) as described in
this document will improve the clarity and accuracy of the regulations.
We are also renumbering Sec. 56.120(b)(4) as Sec. 56.120(c), and
Sec. 56.120(c) as Sec. 56.120(d). We are inserting ``FDA may'' into
newly designated Sec. 56.120(c) so that it is a complete sentence.
FDA may notify relevant State and Federal regulatory Agencies when
warranted to assure that organizations with a need to know about the
IRB's apparent noncompliance are appropriately informed. The revision
would eliminate confusion by stating clearly that FDA is authorized to
notify others about the IRB's noncompliance. We believe these changes
will ensure clarity and improve the accuracy of the regulations.

II. Procedures for Issuing a Direct Final Rule

In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' \1\ that described
when and how we will employ direct final rulemaking. We believe that
this rule is

[[Page 19035]]

appropriate for direct final rulemaking because it is intended to
clarify an existing regulation. We anticipate no significant adverse
comment.
---------------------------------------------------------------------------

\1\ https://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.
---------------------------------------------------------------------------

Consistent with FDA's direct final rulemaking procedures, we are
publishing a companion proposed rule elsewhere in this issue of the
Federal Register. That proposed rule is identical in substance to this
direct final rule. The companion proposed rule will serve the purpose
of issuing a proposed rule under usual notice-and-comment procedures in
the event we withdraw this direct final rule because we receive
significant adverse comment. The comment period for this direct final
rule runs concurrently with the comment period of the companion
proposed rule. We will consider any comments that we receive in
response to the companion proposed rule to be comments also regarding
this direct final rule and vice versa.
If FDA receives any significant adverse comment, we will withdraw
this direct final rule before its effective date by publishing a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate (including challenges to the rule's underlying premise or
approach), or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, we consider whether the comment raises
an issue serious enough to warrant a substantive response in a notice-
and-comment process in accordance with section 553 of the
Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule would not be
considered adverse. A comment recommending a rule change in addition to
the rule would not be considered a significant adverse comment, unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
If we withdraw this direct final rule, FDA will consider all
comments that we received regarding the companion proposed rule as we
develop a final rule through the usual notice-and-comment procedures of
the APA. If we receive no significant adverse comment during the
specified comment period regarding this direct final rule, we intend to
publish a confirmation notice in the Federal Register within 30 days
after the comment period ends.

III. Legal Authority

This rule, if finalized, would amend Sec. 56.120(b). FDA's
authority to modify Sec. 56.120(b) arises from the same authority
under which FDA initially issued this regulation, the IRB regulations,
and general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352,
353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e,
381; 42 U.S.C. 216, 241, 262).

IV. Analysis of Environmental Impact

We have determined under 21 CFR 25.30(h) and 25.34(a) 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.

V. Economic Analysis of Impact

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
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 this rule does not add any additional regulatory
burdens, we certify that this final rule will not have a significant
economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 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 $144
million, using the most current (2014) 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.
The purpose of this final rule is to affirm FDA's longstanding
interpretation of Sec. 56.120(b), that FDA may impose these
administrative actions on a noncompliant IRB until the IRB takes
appropriate corrective action. The amendment will improve the clarity
and accuracy of the regulations. Because this final rule is a
clarification and would impose no additional regulatory burdens, this
regulation is not anticipated to result in any compliance costs, and
the economic impact is expected to be minimal.

VI. Paperwork Reduction Act of 1995

This direct 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.

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, the Agency has concluded
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 56

Human research subjects, Reporting and recordkeeping requirements,
Safety.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
56 is amended as follows:

PART 56--INSTITUTIONAL REVIEW BOARDS

0
1. The authority citation for 21 CFR part 56 is revised to read as
follows:

Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351,
352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371,
379e, 381; 42 U.S.C. 216, 241, 262.

0
2. In Sec. 56.120, redesignate paragraphs (b)(4) and (c) as paragraphs
(c) and (d), respectively, and revise paragraph (b) and newly
designated paragraph (c) to read as follows:

[[Page 19036]]

Sec. 56.120 Lesser administrative actions.

* * * * *
(b) On the basis of the IRB's or the institution's response, FDA
may schedule a reinspection to confirm the adequacy of corrective
actions. In addition, until the IRB or the parent institution takes
appropriate corrective action, the Agency may require the IRB to:
(1) Withhold approval of new studies subject to the requirements of
this part that are conducted at the institution or reviewed by the IRB;
(2) Direct that no new subjects be added to ongoing studies subject
to this part; or
(3) Terminate ongoing studies subject to this part when doing so
would not endanger the subjects.
(c) When the apparent noncompliance creates a significant threat to
the rights and welfare of human subjects, FDA may notify relevant State
and Federal regulatory agencies and other parties with a direct
interest in the Agency's action of the deficiencies in the operation of
the IRB.
* * * * *

Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07523 Filed 4-1-16; 8:45 am]
BILLING CODE 4164-01-P

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