## 57545 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules

which, in combination with the heat generated by the taxi lights and landing lights on the ground reaching the auto-ignition temperature of the fuel, could result in ignition of any fuel or fumes present in the right-hand landing lights compartment.
(f) Compliance

Comply with this AD within the compliance times specified, unless already done.
(g) Retained Repetitive Inspections for Fuel Leaks With No Changes

This paragraph restates the requirements of paragraph (g) of AD 2014–20–01, Amendment 39–17974 (79 FR 59640, October 3, 2014) with no changes. Within 25 flight hours after October 20, 2014, (the effective date of AD 2014–20–01): Do a general visual inspection for any fuel leak in the right-hand landing lights compartment, and do all applicable related investigative and corrective actions, in accordance with Part A of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605–28– 008, Revision 02, dated July 9, 2014, except as required by paragraph (h) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at intervals not to exceed 8 flight hours until the replacement specified in paragraph (j) of this AD has been accomplished.

(h) Retained Corrective Action if Fuel Leak Is Found During Related Investigative Actions With No Changes

This paragraph restates the requirements of paragraph (h) of AD 2014–20–01, Amendment 39–17974 (79 FR 59640, October 3, 2014) with no changes. If any fuel leak is found during the related investigative actions required by paragraph (g) of this AD: Before further flight, do the terminating action specified in paragraph (j) of this AD, or do corrective actions using a method approved by the Manager, New York Aircraft Certification Office (ACO), ANE–170, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.’s TCCA Design Approval Organization (DAO). If approved by the DAO,the approval must include the DAOauthorized signature.
(i) Retained Inspection of Connector Wiring With No Changes

This paragraph restates the requirements of paragraph (j) of AD 2014–20–01, Amendment 39–17974 (79 FR 59640, October 3, 2014) with no changes. For airplanes having new connectors installed, in accordance with Part B of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605–28– 008, dated April 21, 2014: Within 6 months or 150 flight hours after October 20, 2014, (the effective date of AD 2014–20–01), whichever occurs first, do a detailed inspection for damage (cuts) of the connector wiring, in accordance with Part B of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605–28–008, Revision 02, dated July 9, 2014. If any damage (cuts) is found on the wires, before further flight, replace the wire with a new wire identified in kit 605K28–008A, in accordance with the Accomplishment Instructions of Bombardier Alert Service Bulletin A605–28–008, Revision 02, dated July 9, 2014.
(j) New Requirement: Terminating Action— Replacement of Connector

Within 5 months, or 150 flight hours after the effective date of this AD, replace the connector of the fuel boost pump canister of the APU and do all applicable related investigative actions, in accordance with Part B of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605–28– 008, Revision 02, dated July 9, 2014. Accomplishing this replacement terminates the repetitive actions required by paragraph (g) of this AD provided that the following actions are done, as applicable.

(1) If any damage (cuts) is found on the wires, before further flight, replace the wire with a new wire identified in kit 605K28– 008A, in accordance with the Accomplishment Instructions of Bombardier Alert Service Bulletin A605–28–008, Revision 02, dated July 9, 2014.

(2) If any damage is found on an O-ring, before further flight, replace the O-ring with a new O-ring, in accordance with the Accomplishment Instructions of Bombardier Alert Service Bulletin A605–28–008, Revision 02, dated July 9, 2014.

(3) If any fuel leak is found, before further flight, do corrective actions using a method approved by the Manager, New York ACO, ANE–170, FAA; or TCCA; or Bombardier, Inc.’s TCCA DAO. If approved by the DAO,the approval must include the DAOauthorized signature.

(k) Retained Credit for Previous Actions With a Redesignated Paragraph

This paragraph restates paragraph (k) of AD 2014–20–01, Amendment 39–17974 (79 FR 59640, October 3, 2014) with a redesignated paragraph. This paragraph provides credit for actions required by paragraph (j) of this AD, if those actions were performed before October 20, 2014, (the effective date of AD 2014–20–01, Amendment 39–17974 (79 FR 59640, October 3, 2014) using Bombardier Alert Service Bulletin A605–28–008, Revision 01, dated May 28, 2014, which is not incorporated by reference in this AD.

(l) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO, ANE–170, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516–228–7300; fax 516–794–5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD. (2) Contacting the Manufacturer: As of the effective date of this AD, for any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE–170, FAA; or TCCA; or Bombardier, Inc.’s TCCA DAO. If approved by the DAO, the approval must include the DAO-authorized signature.

(m) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF–2014–21, dated July 10, 2014, for related information. This MCAI may be found in the AD docket on the
Internet at http://www.regulations.gov by searching for and locating Docket No. FAA–

2015–3634.

(2) For service information identified in this AD, contact Bombardier, Inc., 400 Co ˆ teVertu Road West, Dorval, Que  ́bec H4S 1Y9, Canada; telephone 514–855–5000; fax 514– 855–7401; email thd.crj@ aero.bombardier.com; Internet http:// www.bombardier.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call

425–227–1221.

Issued in Renton, Washington, on September 15, 2015. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.

[FR Doc. 2015–24020 Filed 9–23–15; 8:45 am]

**BILLING CODE 4910–13–P**



### DEPARTMENT OF TRANSPORTATION

**Federal Aviation Administration**

**14 CFR Part 39**

**[Docket No. FAA–2015–3629; Directorate Identifier 2015–NM–011–AD]** 

**RIN 2120–AA64**



### Airworthiness Directives; Dassault **Aviation Airplanes**

**AGENCY** 

### : Federal Aviation Administration (FAA), DOT.

**ACTION** 

### : Notice of proposed rulemaking (NPRM).

**SUMMARY** 

### : We propose to adopt a new airworthiness directive (AD) for certain Dassault Aviation Model MYSTERE– FALCON 50, MYSTERE–FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. This proposed AD was prompted by a report of an in-flight lightning strike to the WHELEN anti-collision light located on the top of the vertical fin tip that caused severe damage and induced the loss of some airplane functions. This proposed AD would require modification of the anti-collision light bonding. We are


## 57546 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules

proposing this AD to prevent loss of electrical power and essential functions, and possible reduced control of the airplane.

**DATES** 

### : We must receive comments on this proposed AD by November 9, 2015.

**ADDRESSES** 

### : You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

Fax: 202–493–2251. Mail: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590.

Hand Delivery: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

For service information identified in this proposed AD, contact Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201– 440–6700; Internet http:// www.dassaultfalcon.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221.
Examining the AD Docket

You may examine the AD docket on the Internet at http:// www.regulations.gov by searching for and locating Docket No. FAA–2015– 3629; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800–647–5527) is in the **ADDRESSES** 

### section. Comments will be available in the AD docket shortly after receipt.

**FOR FURTHER INFORMATION CONTACT**

### : Tom Rodriguez, Aerospace Engineer, ANM 116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227– 1137; fax 425–227–1139.

**SUPPLEMENTARY INFORMATION** 

### :

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the

**ADDRESSES** 

### section. Include ‘‘Docket No. FAA–2015–3629; Directorate Identifier 2015–NM–011–AD’’ at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http:// www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015–0006, dated January 15, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or ‘‘the MCAI’’), to correct an unsafe condition for certain Dassault Aviation Model MYSTERE–FALCON 50, MYSTERE–FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. The MCAI states:

An occurrence was reported where aFalcon 2000 aeroplane experienced an inflight lightning strike, which caused severe damage and induced the loss of some aeroplane functions. The investigation results revealed that the entering point of the lightning was at the WHELEN anti-collision light located on the top of the vertical fin tip.

When the lightning strike hit the anticollision light, an electric arc occurredbetween the aeroplane structure and the anticollision light and created a conductive path by which the lightning current entered inside the aeroplane. Further analysis has determined that the electrical bonding between the WHELEN anti-collision light, Part Number (P/N) 01–0790044–09, and the fin tip fairing or the No. 2 engine air intake cover is insufficient to withstand a lightning strike.

In case of severe lightning, this condition, if not corrected, could lead to an unsafe condition (loss of electrical power and/or of essential functions) possibly resulting in reduced control of the aeroplane.

To address this potential unsafe condition, Dassault Aviation developed a modification (mod) to improve the WHELEN anti-collision light bonding when the anti-collision light is located on top of the vertical fin tip or on No. 2 engine air intake cover, and issued several Service Bulletins (SB) to modify all affected aeroplanes in service.

For the reasons described above, this[EASA] AD requires modification of the anticollision light bonding.



### You may examine the MCAI in the AD docket on the Internet at http:// www.regulations.gov by searching for and locating Docket No. FAA–2015–

3629.

Related Service Information Under 1 CFR Part 51

We reviewed the following Dassault Aviation service information:

• Dassault Service Bulletin F50–481, dated August 22, 2007.

• Dassault Service Bulletin F900–372, dated August 22, 2007.

• Dassault Service Bulletin F900–378, dated September 19, 2007.

• Dassault Service Bulletin F900EX– 285, dated July 18, 2007.

• Dassault Service Bulletin F900EX– 305, dated September 19, 2007.

• Dassault Service Bulletin F2000– 337, dated July 25, 2007.

• Dassault Service Bulletin F2000EX– 108, dated July 25, 2007.

The service information describes procedures to correct the electrical bonding of the WHELEN anti-collision light located at the vertical fin tip of the airplane. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the

**ADDRESSES** 

### section of this NPRM.
FAA’s Determination and Requirements of This Proposed AD

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type designs.
Costs of Compliance

We estimate that this proposed AD affects 778 airplanes of U.S. registry.

We also estimate that it would take about 12 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $801 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $1,416,738, or $1,821 per product.
Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA’s authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. ‘‘Subtitle VII:


## 57547 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules

Aviation Programs,’’ describes in more detail the scope of the Agency’s authority.

We are issuing this rulemaking under the authority described in ‘‘Subtitle VII, Part A, Subpart III, Section 44701: General requirements.’’ Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect 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.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a ‘‘significant regulatory action’’ under Executive Order 12866;

2. Is not a ‘‘significant rule’’ under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Proposed Amendment

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: **PART 39—AIRWORTHINESS DIRECTIVES** 

■ 

### 1. The authority citation for part 39 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

**§ 39.13 [Amended]**

■ 

### 2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):

Dassault Aviation: Docket No. FAA–2015– 3629; Directorate Identifier 2015–NM–
011–AD.

(a) Comments Due Date

We must receive comments by November
9, 2015.

(b) Affected ADs

None.
(c) Applicability

This AD applies to Dassault Aviation airplanes, certificated in any category, identified in table 1 to paragraph (c) of this
AD.



### TABLE 

### 1 TO 

### PARAGRAPH 

### (c) OF 

### THIS 

### AD—APPLICABILITY

Airplanes Configuration Except airplanes modified through 1

Dassault Mod embodied in production Service Bulletin in service

Dassault Aviation Model

MYSTERE–FALCON 50 airplanes. M1853 is embodied in production or in service through Dassault Service Bulletin F50–241–R2, dated February 9, 2000. M2083 or M3094 2

. Dassault Service Bulletin F50–257–R1, dated July 11, 2001. Dassault Aviation Model

MYSTERE–FALCON 900 airplanes. Group 1: M1682 is embodied in production or in servicethrough Dassault Service Bulletin F900–182, dated November 5, 1997 3

. M5381 .............. Not Applicable.

Dassault Aviation Model

MYSTERE–FALCON 900 airplanes. Group 2: M1682 is embodied in production or in servicethrough Dassault Service Bulletin F900–182, dated November 5, 1997, and Mod M1947 is embodied in production or in service through Dassault Service Bulletin F900– 176–R1, dated November 14, 2001 4

. M5386 .............. Not Applicable.

Dassault Aviation Model FALCON 900EX airplanes. Group 1: M1682 is embodied in production or in service through Dassault Service Bulletin F900EX–025, dated May 27, 1998. M5381 ............... Not Applicable.

Dassault Aviation Model FALCON 900EX airplanes. Group 2: M1682 is embodied in production or in service through Dassault Service Bulletin F900EX–025, dated May 27, 1998, and Mod M1947 is embodied in production or in service through Dassault Service Bulletin F900EX– 19–R1, dated November 14, 2001. M5103 or M5386. Not Applicable.

Dassault Aviation Model FALCON 2000 airplanes. M331 is embodied in production or in service through Dassault Service Bulletin F2000–44, dated December 9, 1998. M810 or M1061 or M2778. Dassault Service Bulletin F2000–111, dated October 28, 1998.Dassault Aviation Model FALCON 2000EX airplanes. M1802 is embodied in production .......................................... M810 or M1061 or M2778. Not Applicable.

1 The excluded airplanes as specified in the Table 1 to Paragraph (c) of this AD—Applicability, embody either one Mod in production or one service bulletin in service, as applicable.

2 Mod M2083, Service Bulletin F50–257, Mod M1947, Service Bulletin F900–176, Service Bulletin F900EX–19, Mod M5103, as applicable, introduce fin tip SATCOM fairing, in production or in service.

3 Group 1: Airplanes with WHELEN anti-collision light located on top of vertical fin tip.

4 Group 2: Airplanes with WHELEN anti-collision light located on top of air intake engine No. 2.

(d) Subject

Air Transport Association (ATA) of America Code 33, Lights. (e) Reason This AD was prompted by a report of anin-flight lightning strike to the WHELEN anticollision light located on the top of the vertical fin tip of a Falcon 2000 airplane that caused severe damage and induced the loss of some airplane functions. We are issuing this AD to prevent loss of electrical power


## 57548 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules

and/or of essential functions, and possible reduced control of the airplane.
(f) Compliance

Comply with this AD within the compliance times specified, unless already done.
(g) Modification

Within 24 months after the effective date of this AD, modify the anti-collision light bonding, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (g)(1) through (g)(7) of this AD.

(1) For Model MYSTERE–FALCON 50 airplanes: Dassault Service Bulletin F50–481, dated August 22, 2007.

(2) For Model MYSTERE–FALCON 900 airplanes with the WHELEN system installed on the fin tip: Dassault Service Bulletin F900–372, dated August 22, 2007.

(3) For Model MYSTERE–FALCON 900 airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900–378, dated September 19, 2007.

(4) For Model FALCON 900EX airplanes with the WHELEN system installed on the fin tip: Dassault Service Bulletin F900EX–285, dated July 18, 2007.

(5) For Model FALCON 900EX airplaneswith the WHELEN system installed on the Sduct cowl: Dassault Service Bulletin F900EX–305, dated September 19, 2007.

(6) For Model FALCON 2000 airplanes: Dassault Service Bulletin F2000–337, dated July 25, 2007.

(7) For Model FALCON 2000EX airplanes: Dassault Service Bulletin F2000EX–108, dated July 25, 2007.

(h) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1137; fax 425–227–1139. Information may be emailed to: 9-ANM-116- AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM– 116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Dassault Aviation’s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

(i) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency Airworthiness Directive 2015–0006, dated January 15, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA–2015–3629.

(2) For service information identified in this AD, contact Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201–440–6700; Internet http:// www.dassaultfalcon.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call

425–227–1221.

Issued in Renton, Washington, on September 2, 2015. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.

[FR Doc. 2015–22803 Filed 9–23–15; 8:45 am]

**BILLING CODE 4910–13–P**



### CONSUMER PRODUCT SAFETY **COMMISSION**

**16 CFR Part 1028**

**Protection of Human Subjects**

**AGENCY** 

### : Consumer Product Safety Commission.

**ACTION** 

### : Proposed rule.

**SUMMARY** 

### : On September 8, 2015, the federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the ‘‘Common Rule’’) published a notice of proposed rulemaking (‘‘NPR’’) amending the Common Rule. Through this proposed rule, the Consumer Product Safety Commission (‘‘CPSC’’ or ‘‘Commission’’) proposes to adopt the Common Rule NPR and solicits public comment on the proposal.

**DATES** 

### : Comments must be received no later than 5 p.m. on December 7, 2015.

**ADDRESSES** 

### : You may submit comments, identified by docket ID number HHS– OPHS–2015–0008, by one of the following methods:

• Federal eRulemaking Portal: http:// www.regulations.gov. Enter the above docket ID number in the ‘‘Enter Keyword or ID’’ field and click on ‘‘Search.’’ On the next Web page, click on ‘‘Submit a Comment’’ action and follow the instructions.

• Mail/Hand delivery/Courier [For paper, disk, or CD–ROM submissions]
to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted without change to www.regulations.gov.

**FOR FURTHER INFORMATION CONTACT**

### : Hope E.J. Nesteruk, Human Factors Engineer, Division of Human Factors, Directorate for Engineering Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301–987–2579; email: hnesteruk@cpsc.gov.

**SUPPLEMENTARY INFORMATION** 

### : I. Background

On June 18, 1991, the Department of Health and Human Services (‘‘HHS’’) issued a rule setting forth the Common Rule requirements for the protection of human subjects. (56 FR 28003). The HHS regulations are codified at 45 CFR part 46. At that time, 14 other agencies, including the CPSC, joined HHS in adopting a uniform set of rules for the protection of human subjects identical to subpart A of 45 CFR part 46. The Common Rule is codified in the CPSC’s regulations at 16 CFR part 1028. The basic provisions of the Common Rule include, among other things, requirements related to the review of human subjects research by an institutional review board, obtaining and documenting informed consent of human subjects, and submitting a written assurance of institutional compliance with the Common Rule.

On September 8, 2015, (80 FR 53933), HHS, on behalf of many of the same agencies that were signatories to the original Common Rule, proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The Common Rule NPR seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The participating departments and agencies proposed these revisions to the regulations because they believe these changes would strengthen protections for research subjects while facilitating important research.

The full description of the proposed revisions to the Common Rule is provided in the Common Rule NPR at 80 FR 53933. Although the CPSC is a signatory to the original Common Rule, the CPSC’s procedural requirements require Commission deliberation and vote on new rulemaking matters. Due to HHS’s expedited schedule regarding publication of the Common Rule NPR in the Federal Register, the CPSC was not