81 FR 19033 - Administrative Actions for Noncompliance; Lesser Administrative Actions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 64 (April 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 64 (April 4, 2016)
| Page Range | 19033-19036 | |
| FR Document | 2016-07523 |
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)] [Rules and Regulations] [Pages 19033-19036] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07523] ======================================================================= ----------------------------------------------------------------------- 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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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\ http://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
![Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations 19033
Regulatory Flexibility Act ■ 4. In § 404.401, revise paragraph (a)(4) ADDRESSES: You may submit comments
We certify that this final rule will not to read as follows: as follows:
have a significant economic impact on § 404.401 Deduction, reduction, and Electronic Submissions
a substantial number of small entities nonpayment of monthly benefits or lump- Submit electronic comments in the
because it applies to individuals only. sum death payments.
following way:
Thus, a regulatory flexibility analysis is * * * * * • Federal eRulemaking Portal: http://
not required under the Regulatory (a) * * * www.regulations.gov. Follow the
Flexibility Act, as amended. (4) An individual under full instructions for submitting comments.
retirement age (see § 404.409) is Comments submitted electronically,
Paperwork Reduction Act
concurrently entitled to disability including attachments, to http://
These rules do not create any new or insurance benefits and to certain public www.regulations.gov will be posted to
affect any existing collections and, disability benefits (see § 404.408); the docket unchanged. Because your
therefore, do not require Office of * * * * * comment will be made public, you are
Management and Budget approval ■ 5. In § 404.408, revise paragraph solely responsible for ensuring that your
under the Paperwork Reduction Act. (a)(2)(ii) to read as follows:
(Catalog of Federal Domestic Assistance comment does not include any
Program No. 96.006, Supplemental Security confidential information that you or a
§ 404.408 Reduction of benefits based on
Income.) disability on account of receipt of certain third party may not wish to be posted,
other disability benefits provided under such as medical information, your or
List of Subjects in 20 CFR Part 404 anyone else’s Social Security number, or
Federal, State, or local laws or plans.
Administrative practice and * * * * * confidential business information, such
procedure; Blind; Disability benefits; (a) * * * as a manufacturing process. Please note
Government employees; Old-age, (2) * * * that if you include your name, contact
Survivors and Disability Insurance; (ii) The individual has not attained information, or other information that
Reporting and recordkeeping full retirement age as defined in identifies you in the body of your
requirements; Social security. § 404.409. comments, that information will be
Dated: March 25, 2016. * * * * * posted on http://www.regulations.gov.
[FR Doc. 2016–07602 Filed 4–1–16; 8:45 am] • If you want to submit a comment
Carolyn W. Colvin,
BILLING CODE 4191–02–P with confidential information that you
Acting Commissioner of Social Security.
do not wish to be made available to the
For the reasons set forth in the public, submit the comment as a
preamble, we amend subparts D and E DEPARTMENT OF HEALTH AND written/paper submission and in the
of part 404 of title 20 of the Code of HUMAN SERVICES manner detailed (see ‘‘Written/Paper
Federal Regulations as set forth below: Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration Written/Paper Submissions
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY 21 CFR Part 56 Submit written/paper submissions as
INSURANCE (1950– ). follows:
[Docket No. FDA–2015–N–5052] • Mail/Hand delivery/Courier (for
Subpart D—[Amended] written/paper submissions): Division of
Administrative Actions for Dockets Management (HFA–305), Food
■ 1. The authority citation for subpart D Noncompliance; Lesser Administrative and Drug Administration, 5630 Fishers
of part 404 continues to read as follows: Actions Lane, Rm. 1061, Rockville, MD 20852.
Authority: Secs. 202, 203(a) and (b), 205(a), AGENCY: Food and Drug Administration, • For written/paper comments
216, 223, 225, 228(a)–(e), and 702(a)(5) of the HHS. submitted to the Division of Dockets
Social Security Act (42 U.S.C. 402, 403(a) Management, FDA will post your
and (b), 405(a), 416, 423, 425, 428(a)–(e), and ACTION: Direct final rule.
comment, as well as any attachments,
902(a)(5)). SUMMARY: The Food and Drug except for information submitted,
■ 2. Amend § 404.317 by revising the Administration (FDA) is amending the marked and identified, as confidential,
fourth sentence to read as follows: regulation describing lesser if submitted as detailed in
administrative actions that may be ‘‘Instructions.’’
§ 404.317 How is the amount of my imposed on an Institutional Review
disability benefit calculated?
Instructions: All submissions received
Board (IRB) that has failed to comply must include the Docket No. FDA–
* * * Your monthly benefit amount with FDA’s IRB regulations. We are 2015–N–5052 for ‘‘Subpart E—
may be reduced if you receive workers’ clarifying that FDA may require the IRB Administrative Actions for
compensation or public disability to withhold approval of new FDA- Noncompliance; Lesser Administrative
payments before you attain full regulated studies, stop the enrollment of Actions.’’ Received comments will be
retirement age (as defined in § 404.409) new subjects in ongoing studies, and placed in the docket and, except for
(see § 404.408). * * * terminate ongoing studies, or any those submitted as ‘‘Confidential
combination of these actions until the Submissions,’’ publicly viewable at
Subpart E—[Amended]
noncompliance with FDA’s IRB http://www.regulations.gov or at the
■ 3. The authority citation for subpart E regulations is corrected. We are taking Division of Dockets Management
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of part 404 continues to read as follows: this action to ensure clarity and improve between 9 a.m. and 4 p.m., Monday
the accuracy of the regulations. through Friday.
Authority: Secs. 202, 203, 204(a) and (e),
205(a) and (c), 216(l), 222(c), 223(e), 224, 225, DATES: This rule is effective August 17, • Confidential Submissions—To
702(a)(5), and 1129A of the Social Security 2016. Submit electronic or written submit a comment with confidential
Act (42 U.S.C. 402, 403, 404(a) and (e), 405(a) comments on this direct final rule or its information that you do not wish to be
and (c), 416(l), 422(c), 423(e), 424a, 425, companion proposed rule by June 20, made publicly available, submit your
902(a)(5), and 1320a–8a); 48 U.S.C. 1801. 2016. comments only as a written/paper
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![19036 Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations
§ 56.120 Lesser administrative actions. ADDRESSES: To view documents are associated with the areas used in the
* * * * * mentioned in this preamble as being Charleston Race Week sailboat races
(b) On the basis of the IRB’s or the available in the docket, go to http:// that can be alleviated by prohibiting
institution’s response, FDA may www.regulations.gov, type USCG–2015– access to the regulated areas.
schedule a reinspection to confirm the 1055 in the ‘‘SEARCH’’ box and click
adequacy of corrective actions. In ‘‘SEARCH.’’ Click on Open Docket IV. Discussion of Comments, Changes,
addition, until the IRB or the parent Folder on the line associated with this and the Rule
institution takes appropriate corrective rule. As noted above, we received no
action, the Agency may require the IRB FOR FURTHER INFORMATION CONTACT: If comments on our NPRM published
to: you have questions about this rule, call February 5, 2016. There are no changes
(1) Withhold approval of new studies or email Lieutenant John Downing, in the regulatory text of this rule from
subject to the requirements of this part Sector Charleston Office of Waterways the proposed rule in the NPRM.
that are conducted at the institution or Management, Coast Guard;
reviewed by the IRB; telephone(843)740–3184, email From April 15, 2016 through April 17,
(2) Direct that no new subjects be John.Z.Downing@uscg.mil. 2016, Charleston Ocean Racing
added to ongoing studies subject to this Association will host three sailboat
SUPPLEMENTARY INFORMATION:
part; or races on Charleston Harbor in
(3) Terminate ongoing studies subject I. Table of Abbreviations Charleston, South Carolina during
to this part when doing so would not Charleston Race Week. Approximately
CFR Code of Federal Regulations
endanger the subjects. DHS Department of Homeland Security 300 sailboats will participate in the
(c) When the apparent noncompliance NPRM Notice of proposed rulemaking three races. This rule establishes a
creates a significant threat to the rights § Section special local regulation on certain
and welfare of human subjects, FDA U.S.C. United States Code waters of Charleston Harbor in
may notify relevant State and Federal Charleston, South Carolina. The special
regulatory agencies and other parties II. Background Information and
Regulatory History local regulation will be enforced daily
with a direct interest in the Agency’s from 8:30 a.m. until 5 p.m. on April 15,
action of the deficiencies in the On November 18, 2015, the 2016 through April 17, 2016. The
operation of the IRB. Charleston Ocean Racing Association special local regulation consists of the
* * * * * notified the Coast Guard that it will following three race areas.
sponsor a series of sailboat races in the
Dated: March 29, 2016. 1. Race Area #1. All waters
Charleston Harbor, Charleston, SC. from
Leslie Kux, encompassed within a 700 yard radius
8:30 a.m. to 5 p.m. April 15, 2016
Associate Commissioner for Policy. through April 17, 2016. In response, on of position 32°46′10″ N. 79°55′15″ W.
[FR Doc. 2016–07523 Filed 4–1–16; 8:45 am] February 5, 2016, the Coast Guard 2. Race Area #2. All waters
BILLING CODE 4164–01–P published a notice of proposed encompassed within a 700 yard radius
rulemaking titled Charleston Race of position 32°46′02″ N. 79°54′15″ W.
Week. There we stated why we issued 3. Race Area #3. All waters
DEPARTMENT OF HOMELAND the NPRM and invited comments on our encompassed within a 700 yard radius
SECURITY proposed regulatory action related to of position 32°45′55″ N. 79°53′39″ W.
this special local regulation. During the
Coast Guard comment period that ended March 7, Except for those persons and vessels
2016, we received no comments. participating in the sailboat races,
33 CFR Part 100 Under good cause provisions in 5 persons and vessels are prohibited from
[Docket Number USCG–2015–1055] U.S.C. 553(d)(3), we are making this rule entering, transiting through, anchoring
effective less than 30 days after its in, or remaining within any of the race
RIN 1625–AA08 areas unless specifically authorized by
publication in the Federal Register. The
Coast Guard finds that good cause exists the Captain of the Port Charleston or a
Special Local Regulation; Charleston designated representative. Persons and
Race Week, Charleston Harbor, for making this rule effective starting
April 15, 2016 because this special local vessels desiring to enter, transit through,
Charleston, SC
regulation is necessary to ensure the anchor in, or remain within any of the
AGENCY: Coast Guard, DHS. safety of life and property during this race areas may contact the Captain of
ACTION: Temporary final rule. high speed boat race and it would be the Port Charleston by telephone at
contrary to public interest not to make (843) 740–7050, or a designated
SUMMARY: The Coast Guard is this rule effective by April 15, 2016. representative via VHF radio on channel
establishing a special local regulation on Also, this regulation will have a limited 16, to request authorization. If
the waters of Charleston Harbor in impact on the waterway for a limited authorization to enter, transit through,
Charleston, SC during the Charleston time and designated representatives will anchor in, or remain within the race
Race Week from April 15, 2016 through be on scene to assist the public with areas is granted by the Captain of the
April 17, 2016. This special local compliance. Port Charleston or a designated
regulation is necessary to ensure the representative, all persons and vessels
safety of participants, spectators, and III. Legal Authority and Need for Rule receiving such authorization must
the general public during the event. The legal basis for the rule is the comply with the instructions of the
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This regulation prohibits persons and Coast Guard’s authority to establish Captain of the Port Charleston or a
vessels from being in the regulated area special local regulations: 33 U.S.C. designated representative. The Coast
unless authorized by the Captain of the 1233. The purpose of the rule is to Guard will provide notice of the
Port Charleston or a designated insure safety of life on navigable waters regulated areas by Local Notice to
representative. of the United States during three Mariners, Broadcast Notice to Mariners,
DATES: This rule is effective from April Charleston Race Week sailboat races. It and on-scene designated
15, 2016 through April 17, 2016. was determined that potential hazards representatives.
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Document Created: 2016-04-02 03:54:10
Document Modified: 2016-04-02 03:54:10
| 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 | Direct final rule. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 19033 | |
| CFR Associated | Human Research Subjects; Reporting and Recordkeeping Requirements and Safety |
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