14894 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled 

‘‘Considerations for the Development of 

Chimeric Antigen Receptor (CAR) T Cell 

Products; Draft Guidance for Industry.’’ 

The draft guidance document is 

intended to assist sponsors, including 

industry and academic sponsors, 

developing CAR T cell products. The 

guidance includes CAR T cell-specific 

recommendations regarding CMC, 

pharmacology and toxicology, and 

clinical study design. While the 

guidance specifically focuses on CAR T 

cell products, much of the information 

and recommendations provided will 

also be applicable to other genetically 

modified lymphocyte products, such as 

CAR Natural Killer cells or T cell 

receptor-modified T cells. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of another human gene 

therapy draft guidance document 

entitled ‘‘Human Gene Therapy 

Products Incorporating Human Genome 

Editing: Draft Guidance for Industry.’’ 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Considerations for the Development 

of Chimeric Antigen Receptor (CAR) T 

Cell Products.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 50 have been 

approved under OMB control number 

0910–0755; the collections of 

information in 21 CFR part 211 have 

been approved under OMB control 

number 0910–0139; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; and the collections 

of information in 21 CFR part 1271 have 

been approved under OMB control 

number 0910–0543. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/ or https://

www.regulations.gov. 

Dated: March 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05539 Filed 3–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1960] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; MedWatch: The 

Food and Drug Administration Safety 

Information and Adverse Event 

Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by April 15, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0291. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–45, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

MedWatch: The FDA Safety 

Information and Adverse Event 

Reporting Program 

OMB Control Number 0910–0291— 

Revision 

I. Background 

MedWatch is FDA’s program for 

reporting serious reactions, product 

quality problems, therapeutic 

inequivalence/failure, and product use 

errors associated with FDA-regulated 


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products. Examples of these products 

include prescription and over-thecounter medicines; biologics such as 

blood components, blood/plasma 

derivatives, and gene therapies; medical 

devices such as hearing aids, breast 

pumps, and pacemakers; combination 

products such as pre-filled drug syringe, 

metered-dose inhalers, and nasal spray; 

special nutritional products such as 

dietary supplements, medical foods, and 

infant formulas; cosmetics such as 

moisturizers, makeup, shampoos, hair 

dyes, and tattoos; and food, such as 

beverages and ingredients added to 

foods. 

MedWatch receives reports from the 

public and, when appropriate, publishes 

safety alerts intended to protect the 

public health. More information 

regarding the MedWatch program, 

including user guides and consumer 

assistance on reporting problems to 

FDA, may be found on our website at 

https://www.fda.gov/safety/medwatchfda-safety-information-and-adverseevent-reporting-program. Reports are 

submitted to FDA by health 

professionals, patients, and consumers, 

and FDA issues an acknowledgement 

upon receipt of the report. Forms may 

be downloaded from our website at 

https://www.fda.gov/safety/medicalproduct-safety-information/medwatchforms-fda-safety-reporting and 

submitted by Fax or mail following the 

instructions; by completing and 

submitting forms online; or by calling 

FDA at 800–FDA–1088 (800–322–1088) 

and reporting by telephone. 

Some adverse event reports (AERs) 

are required to be submitted to FDA 

(mandatory reporting), while other 

reporting is done voluntarily (voluntary 

reporting). Upon receipt of the report, it 

is directed to the FDA center 

responsible for ensuring the product’s 

compliance with statutory requirements 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) and/or any 

related authorities. Certain requirements 

regarding mandatory reporting of 

adverse events or product problems 

have been codified in Agency 

regulations, including those found in 21 

CFR parts 310, 314, 514, 600, 803, 1114, 

and 1271. 

We are revising the information 

collection to include electronic 

submission of AERs, currently approved 

in OMB control number 0910–0645. 

Most reports are submitted using the 

Electronic Submissions Gateway (ESG), 

our centralized system for securely 

receiving electronic submissions. 

Reports may also be submitted via the 

Safety Reporting Portal (SRP), found at 

https://www.safetyreporting.hhs.gov/ 

SRP2/en/Home.aspx?sid=c16bcd94- 

42a8-4a68-9272-df4a62d8462c, which is 

intended to streamline the process of 

reporting product safety issues to FDA 

using ‘‘Rational Questionnaires.’’ 

II. MedWatch Reporting Forms 

A. MedWatch Form FDA 3500 

(Voluntary Reporting for Health 

Professionals) 

Form FDA 3500 is used by healthcare 

professionals as well as consumers to 

submit all reports not mandated by 

Federal law or regulation. Individual 

health professionals are not required to 

submit reports with the exception of 

certain adverse reactions following 

immunization with vaccines as 

mandated by the National Childhood 

Vaccine Injury Act of 1986 (42 U.S.C. 

300aa–1). Form FDA 3500 may be used 

to report serious adverse events, product 

problems, and product use errors and 

therapeutic failures. Reporting is 

supported for drugs, non-vaccine 

biologicals, medical devices, special 

nutritional products, cosmetics, and 

nonprescription (over-the-counter) 

human drug products marketed without 

an approved application. Form FDA 

3500 may also be used to submit reports 

about tobacco products and dietary 

supplements. 

B. MedWatch Form FDA 3500A 

(Mandatory Reporting) 

Form FDA 3500A is used by 

manufacturers, user facilities, 

distributers, importers, and other 

respondents subject to mandatory 

reporting. Mandatory reporting of 

adverse events or product experiences is 

governed by statute and often codified 

in Agency regulations. Mandatory 

reporting of adverse reactions for human 

cells, tissues, and cellular- and tissuebased products is codified at 21 CFR 

1271.350. 

Reporting Under Sections 760 and 

761 of the FD&C Act. The Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act of 2006 (Pub. 

L. 109–462) amended the FD&C Act by 

adding sections 760 and 761 (21 U.S.C. 

379aa and 379aa–1). Section 760 of the 

FD&C Act defines ‘‘adverse event’’ and 

‘‘serious adverse event’’ for 

nonprescription drugs and prescribes 

specific reporting requirements, 

submission timing, and associated 

recordkeeping. The final guidance 

document entitled ‘‘Postmarketing 

Adverse Event Reporting for 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application,’’ available for download at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/postmarketing-adverseevent-reporting-nonprescription-humandrug-products-marketed-withoutapproved, discusses the statutory 

requirements and provides instructions 

on the reporting elements and the use of 

Form FDA 3500A. Similarly, section 

761 of the FD&C Act defines ‘‘adverse 

event’’ and ‘‘serious adverse event’’ for 

dietary supplements and prescribes 

specific reporting requirements, 

submission timing, and associated 

maintenance of reporting records. The 

document entitled ‘‘Guidance for 

Industry; Questions and Answers 

Regarding Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act,’’ available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

guidance-industry-questions-andanswers-regarding-adverse-eventreporting-and-recordkeeping-dietary, 

discusses these statutory requirements 

and provides instruction on the use and 

submission of Form FDA 3500A and 

discusses records required under 

section 761. 

C. MedWatch Form FDA 3500B 

(Voluntary Reporting for Consumers) 

Form FDA 3500B is a consumerfriendly version of Form FDA 3500 and 

is used for voluntary reporting. 

Respondents with access to the internet 

may visit our website at https://

www.fda.gov and download Form FDA 

3500B or contact us for assistance with 

completing and submitting the 

information. Form FDA 3500B is 

available in both English and Spanish. 

III. FDA Safety Reporting Portal 

Rational Questionnaires 

FDA currently receives several types 

of adverse event reports electronically 

via the SRP using rational 

questionnaires. These include: 

1. Reportable Food Registry 

Section 417 of the FD&C Act (21 

U.S.C. 350f) defines ‘‘reportable food’’ 

and establishes reporting requirements 

for articles of foods (other than infant 

formula or dietary supplements) for 

which there is a reasonable probability 

that the use of, or exposure to, will 

cause serious adverse health 

consequences or death to humans or 

animals. We designed the reportable 

food registry (RFR) rational 

questionnaire to enable us to quickly 

identify, track, and remove from 

commerce an article of food (other than 

infant formula or dietary supplements) 

for which there is a reasonable 

probability that the use of, or exposure 

to, such article of food will cause 


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14896 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 

serious adverse health consequences or 

death to humans or animals. FDA’s 

Center for Food Safety and Applied 

Nutrition uses the information to help 

ensure that these products are quickly 

and efficiently removed from the market 

to prevent foodborne illnesses. Both 

mandatory and voluntary RFR reports 

must be submitted via the SRP. 

2. Food, Infant Formula, and Cosmetic 

Adverse Event Reports 

Rational questionnaires have also 

been developed for submitting adverse 

event reports for dietary supplements, 

food, infant formula, and cosmetics. 

3. Animal Food Adverse Event and 

Product Problem Reports 

Section 1002(b) of the FDA 

Amendments Act of 2007 (Pub. L. 110– 

85) directs the Secretary to establish an 

early warning and surveillance system 

to identify adulteration of the pet food 

supply and outbreaks of illness 

associated with pet food. We developed 

the Pet Food Early Warning System 

rational questionnaire as a user-friendly 

data collection tool, as well as a 

questionnaire for collecting voluntary 

adverse event reports associated with 

livestock food. Information collected in 

these voluntary adverse event reports 

contributes to our ability to identify 

adulteration of the livestock food supply 

and outbreaks of illness associated with 

livestock food. We use the information 

collected to help ensure that such 

products are quickly and efficiently 

removed from the market to prevent 

foodborne illnesses. 

4. Voluntary Tobacco Product Adverse 

Event and Product Problem Reports 

The Center for Tobacco Products 

(CTP) has developed two voluntary 

rational questionnaires on the SRP. The 

first is utilized by consumers and 

concerned citizens to report tobacco 

product adverse event or product 

problems. A second rational 

questionnaire is used by tobacco 

product investigators in clinical trials 

with investigational tobacco products. 

Both CTP voluntary rational 

questionnaires capture tobacco-specific 

adverse event and product problem 

information from reporting entities such 

as healthcare providers, researchers, 

consumers, and other users of tobacco 

products. 

In the Federal Register of June 30, 

2021 (86 FR 34754), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. One comment was received 

requesting clarification with regard to 

certain terms applicable to medical 

device reporting and exemptions from 

reporting. We note that information 

collection pertaining to medical device 

reporting is approved under OMB 

control number 0910–0437. The 

comment also discussed electronic 

reporting currently approved in OMB 

control number 0910–0645. Upon 

consideration of the comment and to 

help increase our organizational 

efficiency, we are consolidating the 

related reporting activities currently 

approved in OMB control number 0910– 

0645 into this single information 

collection request. Upon OMB approval 

of our request, we will discontinue 

OMB control number 0910–0645. In 

consideration of the comment, we have 

also proposed the following updates to 

the information collection instruments 

to help clarify information to be 

included in the corresponding data 

fields: 

1. Revising the ‘‘gender’’ field to 

Forms FDA 3500, 3500A, and 3500B; to 

align with Centers for Disease Control 

and Prevention’s use of these terms 

(https://www.cdc.gov/hiv/clinicians/ 

transforming-health/health-careproviders/collecting-sexualorientation.html), with the exception of 

the term ‘‘Undifferentiated,’’ which is 

included in the CDISC (Clinical Data 

Interchange Standards Consortium) 

language (premarket) standards (https:// 

www.cdisc.org/kb/articles/sex-andgender); 

2. Revising Section B of Form FDA 

3500 to the ‘‘product problem’’ field to 

include information about the root 

cause(s) of problem(s). 

3. Revising instructions to clarify 

reporting instructions for paper-based 

reporting pertaining to adverse events 

associated with tobacco products; and 

4. Revising instructions to clarify the 

term ‘‘smoking’’ refers to use of 

combusted products (cigarettes, cigars, 

pipes) to ‘‘tobacco product use,’’ which 

encompasses combusted and noncombusted tobacco products. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Reportable Foods Registry—Mandatory Reports ....... 875 1 875 0.6 (36 minutes) ..... 525 

Reportable Foods Registry—Voluntary Reports ......... 5 1 5 0.6 (36 minutes) ..... 3 

Food, Infant Formula, and Cosmetic Adverse Event 

Reports.

1,165 1.2 1,398 0.6 (36 minutes) ..... 839 

Voluntary Dietary Supplement Adverse Event Reports.360 1.2 432 0.6 (36 minutes) ..... 259 

Mandatory Dietary Supplement Adverse Event Reports.80 12 960 1 ............................. 960 

Animal Food: Pet Food Reports .................................. 2,024 1 2,024 0.6 (36 minutes) ..... 1,214.40 

Animal Food: Livestock Food Reports ........................ 25 1 25 0.6 (36 minutes) ..... 15 

Voluntary Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports to 

SRP (both questionnaires).

204 1 204 0.6 (36 minutes) ..... 122 

Mandatory Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports.1 1 1 0.6 (36 minutes) ..... 1 

Total ...................................................................... ........................ ........................ 5,924 ................................ 3,938.4 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimate of the number of 

respondents and the total annual 

responses is based primarily on 

mandatory and voluntary adverse event 

reports submitted to the Agency. The 

estimated total annual responses are 

based on initial reports. Followup 

reports, if any, are not counted as new 

reports. Based on our experience with 


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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 14897 

adverse event reporting, we assume it 

takes respondents 0.6 hour to submit a 

voluntary adverse event report via the 

SRP, 1 hour to submit a mandatory 

adverse event report via the SRP (except 

CTP, which estimates 0.6 hour), and 0.6 

hour to submit a mandatory AER via the 

ESG (gateway-to-gateway transmission). 

CTP used two data sources to estimate 

the reporting burden for tobacco 

product AEs. CTP researched the 

number of voluntary AE reports 

submitted to the center since the launch 

of the first tobacco questionnaire in the 

SRP in 2014. Our records indicated a 

total of 1,426 initial reports over the last 

7 full calendar years. We used the total 

number of reports to average the number 

of yearly reports to 204. As referenced 

above, the premarket tobacco product 

application rule requires firms to submit 

adverse experience reports for tobacco 

products with marketing orders. The 

burden for these mandatory reports has 

been approved under OMB control 

number 0910–0879. For this collection, 

we have included 1 hour to 

acknowledge the inclusion under this 

collection. Therefore, the estimate for 

CTP voluntary and mandatory reports is 

expected to be 123 hours. 

The submission of mandatory reports 

associated with drug products and 

biological drug products is accounted 

for and approved under OMB control 

number 0910–0230; the submission of 

mandatory reports associated with the 

Vaccine Adverse Event Reporting 

System is accounted for and approved 

under OMB control number 0910–0308; 

medical device report submissions are 

accounted for and approved under OMB 

control number 0910–0437; and the 

submission of mandatory reports 

associated with animal drug products is 

accounted for and approved under OMB 

control number 0910–0284. 

Dated: March 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05514 Filed 3–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0398] 

Human Gene Therapy Products 

Incorporating Human Genome Editing; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

document entitled ‘‘Human Gene 

Therapy Products Incorporating Human 

Genome Editing; Draft Guidance for 

Industry.’’ The draft guidance document 

provides recommendations to sponsors 

developing human gene therapy 

products incorporating genome editing 

(GE) of human somatic cells. 

Specifically, the guidance provides 

recommendations regarding information 

that should be provided in an 

investigational new drug (IND) 

application in order to assess the safety 

and quality of the investigational GE 

product, including information on 

product design, product manufacturing, 

product testing, preclinical safety 

assessment, and clinical trial design. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 14, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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): 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 

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– 

2021–D–0398 for ‘‘Human Gene 

Therapy Products Incorporating Human 

Genome Editing; Draft Guidance for 

Industry.’’ 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 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• 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 

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 Dockets Management 

Staff. 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.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 


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