Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42489 

(a) Applicability 

This AD applies to Model AS350B3 

helicopters with a dual hydraulic system 

installed, certificated in any category. 

Note 1 to paragraph (a) of this AD: The 

dual hydraulic system for Model AS350B3 

helicopters is referred to as Airbus 

modification OP 3082 or OP 3346. 

(b) Unsafe Condition 

This AD defines the unsafe condition as 

lack of hydraulic pressure in a tail rotor 

(T/R) hydraulic system. This condition could 

result in loss of T/R flight control and 

subsequent loss of control of the helicopter. 

(c) Affected ADs 

This AD supersedes AD 2015–22–53, 

Amendment 39–18331 (80 FR 74982, 

December 1, 2015). 

(d) Comments Due Date 

We must receive comments by November 

7, 2017. 

(e) Compliance 

You are responsible for performing each 

action required by this AD within the 

specified compliance time unless it has 

already been accomplished prior to that time. 

(f) Required Actions 

(1) Before further flight, insert a copy of 

this AD into the rotorcraft flight manual, 

Section 4 Normal Operating Procedures, or 

make pen and ink changes to the preflight 

and post-flight procedures as follows: 

(i) Stop performing the yaw load 

compensator check (ACCU TST switch) 

during preflight procedures, and instead 

perform the yaw load compensator check 

during post-flight procedures after rotor shutdown. 

(ii) The yaw servo hydraulic switch 

(collective switch) must be in the ‘‘ON’’ 

(forward) position before takeoff. 

Note 2 to paragraph (f)(1)(ii) of this AD: 

The yaw servo hydraulic switch is also called 

the hydraulic pressure switch or hydraulic 

cut off switch in various Airbus Helicopters 

rotorcraft flight manuals. 

(2) Within 350 hours time-in-service: 

(i) Install a timer relay for the yaw servo 

hydraulic switch (collective switch) by 

following the Accomplishment Instructions, 

paragraph 3.B.2.b.1, 3.B.2.b.2, 3.B.2.b.3, 

3.B.2.b.4, 3.B.2.b.5, or 3.B.2.b.6, as applicable 

to the configuration of your helicopter, of 

Airbus Helicopters Service Bulletin (SB) No. 

AS350–67.00.64, Revision 0, dated February 

25, 2015 (AS350–67.00.64). If your helicopter 

has an automatic pilot system, also comply 

with paragraph 3.B.2.b.7 of AS350–67.00.64. 

(ii) Install an indicator light on the caution 

and warning panel by following the 

Accomplishment Instructions, paragraph 

3.B.2.c.1 or 3.B.2.c.2, as applicable to the 

configuration of your helicopter, of AS350– 

67.00.64. 

(iii) Replace the bistable ACCU TST button 

on the control panel with a monostable 

button as depicted in Figure 1 or Figure 3, 

as applicable to the configuration of your 

helicopter, of Airbus Helicopters SB No. 

AS350–67.00.65, Revision 0, dated August 

25, 2016. 

(3) After the effective date of this AD, do 

not install a bistable ACCU TST button on 

any helicopter. 

(g) Special Flight Permits 

A special flight permit may be issued for 

paragraph (f)(2) of this AD only. 

(h) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Safety Management 

Section, FAA, may approve AMOCs for this 

AD. Send your proposal to: George Schwab, 

Aviation Safety Engineer, Safety Management 

Section, Rotorcraft Standards Branch, FAA, 

10101 Hillwood Pkwy., Fort Worth, TX 

76177; telephone (817) 222–5110; email 

9-ASW-FTW-AMOC-Requests@faa.gov. 

(2) For operations conducted under a 14 

CFR part 119 operating certificate or under 

14 CFR part 91, subpart K, we suggest that 

you notify your principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office or 

certificate holding district office before 

operating any aircraft complying with this 

AD through an AMOC. 

(i) Additional Information 

(1) Airbus Helicopters SB No. AS350– 

67.00.66, Revision 1, dated October 22, 2015, 

which is not incorporated by reference, 

contains additional information about the 

subject of this AD. For service information 

identified in this AD, contact Airbus 

Helicopters, 2701 N. Forum Drive, Grand 

Prairie, TX 75052; telephone (972) 641–0000 

or (800) 232–0323; fax (972) 641–3775; or at 

http://www.helicopters.airbus.com/website/ 

en/ref/Technical-Support_73.html. You may 

review the referenced service information at 

the FAA, Office of the Regional Counsel, 

Southwest Region, 10101 Hillwood Pkwy, 

Room 6N–321, Fort Worth, TX 76177. 

(2) The subject of this AD is addressed in 

European Aviation Safety Agency (EASA) AD 

No. 2016–0220, dated November 4, 2016. 

You may view the EASA AD on the Internet 

at http://www.regulations.gov in the AD 

Docket. 

(j) Subject 

Joint Aircraft Service Component (JASC) 

Code: 2910, Main Hydraulic System. 

Issued in Fort Worth, Texas, on August 29, 

2017. 

Scott A. Horn, 

Deputy Director for Regulatory Operations, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[FR Doc. 2017–18973 Filed 9–7–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2017–0867; Product 

Identifier 2017–CE–021–AD] 

RIN 2120–AA64 

Airworthiness Directives; Viking Air 

Limited Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for all 

Viking Air Limited Models DHC–2 Mk. 

I, DHC–2 Mk. II, and DHC–2 Mk. III 

airplanes. This proposed AD results 

from mandatory continuing 

airworthiness information (MCAI) 

originated by an aviation authority of 

another country to identify and correct 

an unsafe condition on an aviation 

product. The MCAI describes the unsafe 

condition as cracking found in the wing 

rear spar web at the wing station where 

the flap outboard hinge is attached. We 

are issuing this proposed AD to require 

actions to address the unsafe condition 

on these products. 

DATES: We must receive comments on 

this proposed AD by October 23, 2017. 

ADDRESSES: You may send comments 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 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

For service information identified in 

this proposed AD, contact Viking Air 

Limited Technical Support, 1959 De 

Havilland Way, Sidney, British 

Columbia, Canada, V8L 5V5; telephone: 

(North America) (800) 663–8444; fax: 

(250) 656–0673; email: 

technical.support@vikingair.com; 

Internet: http://www.vikingair.com/ 

support/service-bulletins. You may 

review this referenced service 

information at the FAA, Policy and 

Innovation Division, 901 Locust, Kansas 


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42490 Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 

City, Missouri 64106. For information 

on the availability of this material at the 

FAA, call (816) 329–4148. 

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–2017– 

0867; 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 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: Aziz 

Ahmed, Aerospace Engineer, FAA, New 

York ACO Branch, 1600 Stewart 

Avenue, Suite 410, Westbury, New York 

11590; telephone: (516) 228–7329; fax: 

(516) 794–5531; email: aziz.ahmed@

faa.gov. 

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–2017–0867; Product Identifier 

2017–CE–021–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 because of those 

comments. 

We will post all comments we 

receive, without change, to http://

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 Transport Canada, which is the 

aviation authority for Canada, has 

issued AD Number CF–2017–17, dated 

May 18, 2017 (referred to after this as 

‘‘the MCAI’’), to correct an unsafe 

condition for all Viking Air Limited 

Models DHC–2 Mk. I, DHC–2 Mk. II, 

and DHC–2 Mk. III airplanes and was 

based on mandatory continuing 

airworthiness information originated by 

an aviation authority of another country. 

The MCAI states: 

It was reported that a crack was found in 

the wing rear spar web, part number 

C2W1007, at wing station 123.5 where the 

flap outboard hinge is attached. An aileron 

hinge bracket has also been found cracked. 

Viking Air Ltd. analysis shows that similar 

cracks may develop on the wing rear spar 

web and flap/aileron hinge arm support 

brackets at the other flap/aileron hinge 

attachment locations. 

Undetected cracking of the wing rear spar 

or flap/aileron hinge bracket may lead to the 

failure of the component with consequent 

loss of aeroplane control. 

The MCAI requires inspecting the lefthand and right-hand wing rear spar and 

the flap/aileron hinge air support 

brackets for cracks, damage, or 

discrepancy and repairing or replacing 

any cracked, damaged, or discrepant 

parts. You may examine the MCAI on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2017– 

0867. 

Related Service Information Under 1 

CFR Part 51 

Viking Air Limited has issued 

DHC–2 Beaver Service Bulletin Number: 

V2/0009, Revision A, dated February 10, 

2017. The service information describes 

procedures for inspecting the left-hand 

and right-hand wing rear spars, the flap/ 

aileron hinge brackets, and the exterior 

store support bracket for cracks, 

damage, and discrepancies and specifies 

repairing or replacing any cracked, 

damaged, or discrepant parts. 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 the 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 this State of 

Design Authority, they have notified us 

of the unsafe condition described in the 

MCAI and service information 

referenced above. We are proposing this 

AD because we evaluated all 

information and determined the unsafe 

condition exists and is likely to exist or 

develop on other products of the same 

type design. 

Interim Action 

We consider this proposed AD 

interim action. The inspection report 

required by this proposed AD allows us 

to obtain better information into the 

nature, cause, and extent of the damage 

to the wing rear spars and flap/aileron 

hinge arm support brackets and to 

develop final action to address the 

unsafe condition. Once final action has 

been identified, we may consider 

further rulemaking. 

Costs of Compliance 

We estimate that this proposed AD 

will affect 140 products of U.S. registry. 

We also estimate that it would take 

about 11work-hours per product to 

comply with the basic inspection 

requirements of this proposed AD. The 

average labor rate is $85 per work-hour. 

Based on these figures, we estimate 

the basic cost of this proposed AD on 

U.S. operators to be $130,900, or $935 

per product. 

In addition, the following is an 

estimate of possible necessary follow-on 

replacement actions. We have no way of 

determining the number of products 

that may need these actions. 

Part No. 

Left-hand (LH) or 

right-hand (RH) 

wing 

Description Number per 

airplane Parts cost 

Number of 

work-hours 

to replace 

C2W123A ............. Both (one per 

wing).

Hinge bracket LH inboard (flap)/ RH 

outboard (aileron).

2 ............................ $288 for both ........ 12 for both. 

C2W124A ............. Both (one per 

wing).

Hinge bracket RH inboard (flap)/ LH 

outboard (aileron).

2 ............................ $288 for both ........ 12 for both. 

C2W143 ............... Both (four per 

wing).

Hinge bracket, flap and aileron (common part—multiple wing stations 

(WS)).

8 ............................ $271 for all eight ... 12 for all eight. 

C2W143A (Agricultural Option).Both (one per 

wing).

Agricultural (optional configuration)— 

hinge bracket, support arm (IPC 

PSM 1–2–4 Figure 128, Item 15).

2 (if applies) .......... $271 for both ........ 12 for both. 

C2W63 ................. LH ........................ Inboard spar, rear spar ..................... ............................... $277 ...................... 60. 

C2W64 ................. RH ....................... Inboard spar, rear spar ..................... ............................... $277 ...................... 60. 


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Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42491 

Part No. 

Left-hand (LH) or 

right-hand (RH) 

wing 

Description Number per 

airplane Parts cost 

Number of 

work-hours 

to replace 

C2W155 ............... Both (one per 

wing).

Intermediate spar .............................. 2 ............................ $563 for both ........ 60 for both. 

C2W65A ............... LH ........................ Spar WS 89.16 to WS 170.16 .......... 1 * .......................... $835 ...................... 60. 

C2W66A ............... RH ....................... Spar WS 89.16 to WS 170.16 .......... 1 * .......................... $835 ...................... 60. 

C2W67A ............... LH ........................ Outboard spar, WS 170.16 to WS 

245.75.

1 * .......................... $835 ...................... 60. 

C2W68A ............... RH ....................... Outboard spar, WS 170.16 to WS 

245.75.

1 * .......................... $835 ...................... 60. 

* To replace any wing spar section takes 60 work-hours. 

To replace all four wing spar sections 

per wing takes 240 work-hours. 

Paperwork Reduction Act 

A federal agency may not conduct or 

sponsor, and a person is not required to 

respond to, nor shall a person be subject 

to penalty for failure to comply with a 

collection of information subject to the 

requirements of the Paperwork 

Reduction Act unless that collection of 

information displays a current valid 

OMB control number. The control 

number for the collection of information 

required by this AD is 2120–0056. The 

paperwork cost associated with this AD 

has been detailed in the Costs of 

Compliance section of this document 

and includes time for reviewing 

instructions, as well as completing and 

reviewing the collection of information. 

Therefore, all reporting associated with 

this AD is mandatory. Comments 

concerning the accuracy of this burden 

and suggestions for reducing the burden 

should be directed to the FAA at 800 

Independence Ave. SW., Washington, 

DC 20591. ATTN: Information 

Collection Clearance Officer, AES–2000. 

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: 

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. 

This AD is issued in accordance with 

authority delegated by the Executive 

Director, Aircraft Certification Service, 

as authorized by FAA Order 8000.51C. 

In accordance with that order, issuance 

of ADs is normally a function of the 

Compliance and Airworthiness 

Division, but during this transition 

period, the Executive Director has 

delegated the authority to issue ADs 

applicable to small airplanes and 

domestic business jet transport 

airplanes to the Director of the Policy 

and Innovation Division. 

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 AD: 

Viking Air Limited: Docket No. FAA–2017– 

0867; Product Identifier 2017–CE–021– 

AD. 

(a) Comments Due Date 

We must receive comments by October 23, 

2017. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Viking Air Limited 

Models DHC–2 Mk. I, DHC–2 Mk. II, and 

DHC–2 Mk. III airplanes, all serial numbers, 

certificated in any category. 

(d) Subject 

Air Transport Association of America 

(ATA) Code 57: Wings. 

(e) Reason 

This AD was prompted by mandatory 

continuing airworthiness information (MCAI) 

originated by an aviation authority of another 

country to identify and correct an unsafe 

condition on an aviation product. The MCAI 

describes the unsafe condition as cracking 

found in the wing rear spar web at the wing 

station (WS) where the flap outboard hinge 

is attached. We are issuing this AD to detect 

and correct cracks in the wing rear spars and 

the flap/aileron hinge arm support brackets, 

which could cause these parts to fail. Failure 

of the wing rear spars and the flap/aileron 

hinge arm support brackets could result in 

loss of control. 

(f) Actions and Compliance 

Unless already done, do the actions in 

paragraphs (f)(1) through (5) of this AD: 

(1) Within the next 400 hours time-inservice (TIS) after the effective date of this 

AD, visually inspect the left-hand and righthand wing rear spar and flap/aileron hinge 

arm support brackets following the 

Accomplishment Instructions of Viking 

DHC–2 Beaver Service Bulletin Number: V2/ 

0009, Revision A, dated February 10, 2017 

(SB V2/0009, Revision A). 


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(2) For airplanes with agricultural 

configuration installed (SOO Mod 2/984), 

within the next 400 hours TIS after the 

effective date of this AD, inspect the exterior 

store support arm bracket at wing station 

(WS) 101.24 following the Accomplishment 

Instructions of SB V2/0009, Revision A. 

(3) If any discrepancies are found during 

the inspections required in paragraphs (f)(1) 

and (2) of this AD, before further flight, repair 

or replace using a method approved by the 

Manager, New York ACO Branch, FAA; or 

Transport Canada; or Viking Air Limited’s 

Transport Canada Design Organization 

Approval (DOA). If approved by the DOA, 

the approval must include the DOAauthorized signature. 

(4) Within 30 days after completing the 

inspections required in paragraphs (f)(1) and 

(2) of this AD, using the Operator Reply Form 

on page 7 of SB V2/0009, Revision A, report 

the inspection results to Viking Air Limited 

at the address specified in paragraph (h) of 

this AD. 

(5) As of the effective date of this AD, do 

not install a wing on any airplane affected by 

this AD unless it has been inspected as 

specified in paragraph (f)(1) of this AD and 

paragraph (f)(2) of this AD, as applicable, and 

is found free of any discrepancies. 

(g) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, New York ACO 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. Send 

information to ATTN: Aziz Ahmed, 

Aerospace Engineer, FAA, New York ACO 

Branch, 1600 Stewart Avenue, Suite 410, 

Westbury, New York 11590; telephone: (516) 

228–7329; fax: (516) 794–5531; email: 

aziz.ahmed@faa.gov. Before using any 

approved AMOC on any airplane to which 

the AMOC applies, notify your appropriate 

principal inspector (PI) in the FAA Flight 

Standards District Office (FSDO), or lacking 

a PI, your local FSDO. 

(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, New York ACO Branch, 

FAA; or Transport Canada; or Viking Air 

Limited’s Transport Canada Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, a federal 

agency may not conduct or sponsor, and a 

person is not required to respond to, nor 

shall a person be subject to a penalty for 

failure to comply with a collection of 

information subject to the requirements of 

the Paperwork Reduction Act unless that 

collection of information displays a current 

valid OMB Control Number. The OMB 

Control Number for this information 

collection is 2120–0056. Public reporting for 

this collection of information is estimated to 

be approximately 5 minutes per response, 

including the time for reviewing instructions, 

completing and reviewing the collection of 

information. All responses to this collection 

of information are mandatory. Comments 

concerning the accuracy of this burden and 

suggestions for reducing the burden should 

be directed to the FAA at: 800 Independence 

Ave. SW., Washington, DC 20591, Attn: 

Information Collection Clearance Officer, 

AES–200. 

(h) Related Information 

Refer to MCAI Transport Canada AD 

Number CF–2017–17, dated May 18, 2017, 

for related information. You may examine the 

MCAI on the Internet at http://

www.regulations.gov by searching for and 

locating Docket No. FAA–2017–0867. For 

service information related to this AD, 

contact Viking Air Limited Technical 

Support, 1959 De Havilland Way, Sidney, 

British Columbia, Canada, V8L 5V5; 

telephone: (North America) (800) 663–8444; 

fax: (250) 656–0673; email: 

technical.support@vikingair.com; Internet: 

http://www.vikingair.com/support/servicebulletins. You may review this referenced 

service information at the FAA, Policy and 

Innovation Division, 901 Locust, Kansas City, 

Missouri 64106. For information on the 

availability of this material at the FAA, call 

(816) 329–4148. 

Issued in Kansas City, Missouri, on August 

29, 2017. 

Melvin Johnson, 

Deputy Director, Policy and Innovation 

Division, Aircraft Certification Service. 

[FR Doc. 2017–18900 Filed 9–7–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2017–N–5092] 

Review of Existing Center for Biologics 

Evaluation and Research Regulatory 

and Information Collection 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for comments and 

information. 

SUMMARY: As part of the implementation 

of Executive Order 13771 entitled, 

‘‘Reducing Regulation and Controlling 

Regulatory Costs,’’ and Executive Order 

13777 entitled, ‘‘Enforcing the 

Regulatory Reform Agenda,’’ the Food 

and Drug Administration (FDA, Agency, 

or we) is seeking comments and 

information from interested parties to 

help FDA identify existing regulations 

and related paperwork requirements 

that could be modified, repealed, or 

replaced, consistent with the law, to 

achieve meaningful burden reduction 

while allowing us to achieve our public 

health mission and fulfill statutory 

obligations. This document relates to 

the products regulated by the Center for 

Biologics Evaluation and Research 

(CBER). 

DATES: Submit either electronic or 

written comments on this document by 

December 7, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 7, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 7, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 


sradovich on DSK3GMQ082PROD with PROPOSALS