3158 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

FDA withdrew the approval of multiple 

applications containing more than 325 

mg of acetaminophen whose sponsors 

voluntarily requested withdrawal and 

waived their opportunity for a hearing 

on or before that date. 

In a letter dated November 22, 2016, 

Watson voluntarily requested that FDA 

withdraw approval of its ANDA 074699 

for Pentazocine and Acetaminophen 

Tablets, 25 mg/650 mg, and waived its 

opportunity for a hearing. The letter also 

stated that the product was not 

manufactured or distributed after 

January 14, 2014. 

Therefore, under § 314.150(d), 

approval of this ANDA, and all 

amendments and supplements thereto, 

is withdrawn (see DATES). Distribution 

of this product in interstate commerce 

without an approved application is 

illegal and subject to regulatory action 

(see sections 505(a) and 301(d) of the 

FD&C Act (21 U.S.C. 355(a) and 331(d)). 

The safety issue discussed in this 

document and the January 14, 2011, 

Federal Register document is limited to 

products containing more than 325 mg 

of acetaminophen per dosage unit. 

Thus, the withdrawal of approval of this 

product does not change the approval 

status of any product with 325 mg or 

less of acetaminophen per dosage unit 

that is approved under the same 

application, or that refers to or relies on 

the withdrawn application. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01118 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0071] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Draft Guidance for 

Industry: Modified Risk Tobacco 

Product Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

‘‘Draft Guidance for Industry: Modified 

Risk Tobacco Product Applications’’ 

(MRTPA). 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 26, 2018. 

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 March 26, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 26, 2018. 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 

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– 

2012–D–0071 for ‘‘Draft Guidance for 

Industry: Modified Risk Tobacco 

Product Applications’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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. 

• 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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3159 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Draft Guidance for Industry: Modified 

Risk Tobacco Product Applications 

OMB Control Number 0910—NEW 

In the Federal Register of April 3, 

2012 (77 FR 20026), FDA published a 

notice of availability including the PRA 

analysis. FDA is republishing the 

paperwork analysis with updates to 

satisfy the requirements of the PRA. 

This draft guidance describes the 

information that the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) requires 

in an MRTPA submission as well as 

FDA’s recommendations regarding the 

scientific evidence that should be 

contained in a MRTPA for FDA to make 

an assessment and conduct an ongoing 

review of modified risk tobacco 

products (MRTPs). The draft guidance 

also permits the filing of a single 

application for any MRTP that is also a 

new tobacco product under section 910 

of the FD&C Act (21 U.S.C. 387k). The 

draft guidance discusses, among other 

things: (1) Who submits MRTPAs; (2) 

when to submit a MRTPA; (3) what 

information section 911 of the FD&C Act 

(21 U.S.C. 387j) requires applicants to 

submit in a MRTPA; (4) what scientific 

evidence FDA recommends applicants 

include in a MRTPA; (5) what 

information should be collected through 

postmarket surveillance and studies; 

and (6) how to organize and submit a 

MRTPA. The purpose of the proposed 

information collection is to allow FDA 

to collect statutorily mandated 

information regarding modified risk 

tobacco products and other information 

that will facilitate FDA’s effective and 

efficient review of MRTPAs. 

Modified risk tobacco products are 

tobacco products that are sold or 

distributed for use to reduce harm or the 

risk of tobacco-related disease 

associated with commercially marketed 

tobacco products (section 911(b)(1) of 

the FD&C Act). No person may 

introduce or deliver for introduction 

into interstate commerce any MRTP 

unless an order issued pursuant to 

section 911(g) is effective with respect 

to that product (section 911(a) of the 

FD&C Act). 

Under section 911(d) of the FD&C Act, 

a MRTPA must contain: 

• A description of the proposed 

product and any proposed advertising 

and labeling; 

• The conditions for using the 

product; 

• The formulation of the product; 

• Sample product labels and labeling; 

• All documents (including 

underlying scientific information) 

relating to research findings conducted, 

supported, or possessed by the tobacco 

product manufacturer relating to the 

effect of the product on tobacco-related 

diseases and health-related conditions, 

including information both favorable 

and unfavorable to the ability of the 

product to reduce risk or exposure and 

relating to human health; 

• Data and information on how 

consumers actually use the tobacco 

product; and 

• Such other information as the 

Secretary may require. 

Further, FDA’s regulation 

implementing the National 

Environmental Policy Act of 1969 

requires that ‘‘[a]ll applications or 

petitions requesting agency action 

require the submission of an 

[environmental assessment] or a claim 

of categorical exclusion’’ (21 CFR 

25.15(a)). 

Section 911(g) of the FD&C Act 

describes the demonstrations applicants 

must make to obtain an order from FDA. 

Section 911(g)(1) and (2) of the FD&C 

Act set forth two bases for FDA to issue 

an order. 

A ‘‘risk modification order’’ is an 

order permitting the introduction or 

delivery for introduction into interstate 

commerce of a tobacco product that 

FDA has found meets the criteria for an 

order under section 911(g)(1) of the 

FD&C Act. In order for FDA to issue a 

risk modification order under section 

911(g)(1) of the FD&C Act, the applicant 

must demonstrate that the proposed 

modified risk tobacco product, as it is 

actually used by consumers, will: 

• Significantly reduce harm and the 

risk of tobacco-related disease to 

individual tobacco users and 

• Benefit the health of the population 

as a whole taking into account both 

users of tobacco products and persons 

who do not currently use tobacco 

products. 

An ‘‘exposure modification order’’ is 

an order permitting the introduction or 

delivery for introduction into interstate 

commerce of a tobacco product that 

reduces or eliminates exposure to a 

substance and for which the available 

scientific evidence suggests that a 

measurable and substantial reduction in 

morbidity and mortality is likely to be 

demonstrated in future studies. In order 

for FDA to issue an exposure 

modification order, the applicant must 

satisfy all of the criteria for issuance of 

an order under section 911(g)(2) of the 

FD&C Act. 

FDA may issue an exposure 

modification order under section 

911(g)(2) of the FD&C Act (the ‘‘special 

rule’’) if it determines that the applicant 

has demonstrated that: 

• Such an order would be appropriate 

to promote the public health; 

• Any aspect of the label, labeling, 

and advertising for the product that 

would cause the product to be a MRTP 

is limited to an explicit or implicit 

representation that the tobacco product 

or its smoke does not contain or is free 

of a substance or contains a reduced 

level of a substance, or presents a 

reduced exposure to a substance in 

tobacco smoke; 

• Scientific evidence is not available 

and, using the best available scientific 

methods, cannot be made available 

without conducting long-term 

epidemiological studies for an 

application to meet the standards for 

obtaining an order under section 

911(g)(1); and 

• The scientific evidence that is 

available without conducting long-term 

epidemiological studies demonstrates 


sradovich on DSK3GMQ082PROD with NOTICES
3160 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

that a measurable and substantial 

reduction in morbidity or mortality 

among individual tobacco users is 

reasonably likely in subsequent studies 

(section 911(g)(2)(A) of the FD&C Act). 

Furthermore, for FDA to issue an 

exposure modification order, FDA must 

find that the applicant has demonstrated 

that: 

• The magnitude of overall 

reductions in exposure to the substance 

or substances, which are the subject of 

the application is substantial, such 

substance or substances are harmful, 

and the product as actually used 

exposes consumers to the specified 

reduced level of the substance or 

substances; 

• The product as actually used by 

consumers will not expose them to 

higher levels of other harmful 

substances compared to the similar 

types of tobacco products then on the 

market unless such increases are 

minimal and the reasonably likely 

overall impact of use of the product 

remains a substantial and measurable 

reduction in overall morbidity and 

mortality among individual tobacco 

users; 

• Testing of actual consumer 

perception shows that, as the applicant 

proposes to label and market the 

product, consumers will not be misled 

into believing that the product is or has 

been demonstrated to be less harmful, or 

presents or has been demonstrated to 

present less of a risk of disease than one 

or more other commercially marketed 

tobacco products; and 

• Issuance of the exposure 

modification order is expected to benefit 

the health of the population as a whole 

taking into account both users of 

tobacco products and persons who do 

not currently use tobacco products 

(section 911(g)(2)(B) of the FD&C Act). 

In evaluating the benefit to health of 

individuals and of the population as a 

whole under section 911(g)(1) and (2) of 

the FD&C Act, FDA must take into 

account: 

• The relative health risks the MRTP 

presents to individuals; 

• The increased or decreased 

likelihood that existing tobacco product 

users who would otherwise stop using 

such products will switch to using the 

modified risk tobacco product; 

• The increased or decreased 

likelihood that persons who do not use 

tobacco products will start using the 

modified risk tobacco product; 

• The risks and benefits to persons 

from the use of the MRTP compared to 

the use of smoking cessation drug or 

device products approved by FDA to 

treat nicotine dependence; and 

• Comments, data, and information 

submitted to FDA by interested persons 

(section 911(g)(4) of the FD&C Act). 

Furthermore, FDA must ensure that 

the advertising and labeling of the 

MRTP enable the public to comprehend 

the information concerning modified 

risk and to understand the relative 

significance of such information in the 

context of total health and in relation to 

all of the tobacco-related diseases and 

health conditions (section 911(h)(1) of 

the FD&C Act). 

FDA intends to determine whether it 

will issue an order under section 911(g) 

within 360 days after the receipt of a 

complete application and will issue 

such an order only if the application 

satisfies all the applicable requirements 

in section 911 of the FD&C Act. 

A risk modification order issued 

under section 911(g)(1) will be effective 

for the period of time specified in the 

order issued by FDA (section 911(h)(4) 

of the FD&C Act). An applicant to whom 

a risk modification order is issued under 

section 911(g)(1) must conduct 

postmarket surveillance and studies 

(section 911(i)(1) of the FD&C Act). 

An exposure modification order 

issued under section 911(g)(2) of the 

FD&C Act will be effective for a term of 

not more than 5 years. FDA may renew 

an exposure modification order if the 

applicant files a new application, and 

FDA finds that the requirements for 

such order under section 911(g)(2) 

continue to be satisfied (section 

911(g)(2)(C)(i) of the FD&C Act). 

Further, an exposure modification order 

will be conditioned on the applicant’s 

agreement to conduct postmarket 

surveillance and studies and to submit 

the results of such surveillance and 

studies to FDA annually (section 

911(g)(2)(C)(ii) and (iii) of the FD&C 

Act). 

The postmarket surveillance and 

studies that all applicants who receive 

orders are required to conduct are 

intended to determine the effect of 

issuance of an order on consumer 

perception, behavior, and health, and 

enable FDA to review the accuracy of 

the determinations upon which an order 

was based (section 911(g)(2)(C)(ii) and 

911(i)(1) of the FD&C Act). An applicant 

who receives a risk modification order 

must also conduct postmarket 

surveillance and studies that provide 

information FDA determines is 

otherwise necessary regarding the use or 

health risks involving the tobacco 

product (section 911(i)(1) of the FD&C 

Act). 

If the proposed MRTP is a new 

tobacco product within the meaning of 

section 910(a)(1), the new tobacco 

product must satisfy any applicable 

premarket review requirements under 

section 910 of the FD&C Act, in addition 

to any requirements under section 911 

of the FD&C Act. A new tobacco product 

must be found to be substantially 

equivalent, exempt from the 

requirement to obtain a substantial 

equivalence determination, or have a 

marketing authorization order under 

section 910(c)(1)(A)(i) of the FD&C Act. 

The collections of information relating 

to premarket review described in the 

‘‘Guidance for Industry: Section 905(j) 

Reports: Demonstrating Substantial 

Evidence for Tobacco Products’’ (OMB 

control number 0910–0673), 21 CFR 

part 1107 (‘‘Establishment Registration, 

Product Listing, and Substantial 

Equivalence Reports’’) (OMB control 

number 0910–0684), and ‘‘Deeming 

Tobacco Products To Be Subject to the 

FD&C Act ’’ (OMB control number 

0910–0768) have been previously 

approved by OMB. An applicant may 

file the appropriate report or application 

to satisfy any applicable premarket 

review requirements and a separate 

application under section 911 of the 

FD&C Act. To the extent data or 

information contained in the premarket 

review portion of the application is also 

relevant to or required for the modified 

risk determination, FDA encourages the 

applicant to cross-reference that data or 

information rather than duplicate it in 

the modified risk portion of the 

application. Additionally, due to the 

many similarities between the content 

requirements of sections 910(b)(1) (for 

premarket tobacco applications 

(PMTAs)) and 911(d) (for MRTPAs) of 

the FD&C Act, we recommend 

submitting a single application to seek 

both a marketing order under section 

910 of the FD&C Act and a modified risk 

order under section 911 of the FD&C 

Act. The single application must 

include the information required for 

premarket review under section 910(b) 

of the FD&C Act, as well as the 

information required to support 

issuance of an order under section 

911(g) of the FD&C Act. 

Description of Respondents: The 

respondents to this collection of 

information are applicants who are 

responsible for creating and submitting 

MRTP applications and who wish to 

obtain an FDA order to allow them to 

market their product. While it is 

expected that many of the respondents 

will be manufacturers, respondents 

could include importers, distributors, 

and retailers of tobacco products. 

FDA estimates the burden of this 

collection of information as follows: 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3161 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

MRTPA (section 911(d) of FD&C Act) ................................ 3 1 3 10,000 30,000 

Environmental analysis (21 CFR 25.15) .............................. 3 1 3 320 960 

Request for a meeting prior to submitting a MRTPA .......... 8 1 8 40 320 

All activities related to postmarket surveillance studies, including submission of protocols, conduct of studies, and 

annual reporting (section 911(g)(2)(C)(ii), 911(i)(1) and 

(2)) .................................................................................... 5 1 5 5,000 25,000 

Requests for renewal (section 911(g)(2)(C)(i) and 

911(h)(4)) .......................................................................... 1 1 1 1,000 1,000 

Total Hours ................................................................... ........................ ........................ ........................ ........................ 57,280 

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

Table 1 describes the annual reporting 

burden as a result of submitting a 

MRTPA. FDA estimates that it will 

receive three MPRTAs annually and that 

it will take the applicant 10,000 hours 

per response to conduct studies and 

collect the information needed to 

support an MRTPA. FDA is also 

including an estimation of the burden 

associated with preparing 

environmental analyses. FDA estimates 

that it will take an additional 320 hours 

to prepare any environmental analyses. 

FDA encourages persons considering 

developing a MRTPA to meet with the 

Center for Tobacco Products to discuss 

MRTPA submission and investigational 

requirements. FDA anticipates that eight 

respondents considering developing 

MRTPAs may request meetings with 

FDA. FDA estimates it will take 40 

hours per response to prepare a meeting 

request, including background 

information. 

Section 911 of the FD&C Act requires 

applicants to whom FDA issues orders 

to conduct postmarket surveillance and 

studies and submit relevant information 

to FDA on an annual basis. Applicants 

must submit and receive FDA approval 

of surveillance protocols. FDA estimates 

that it will take 5,000 hours per 

response to collect and submit the 

protocol information to FDA, conduct 

the postmarket surveillance and studies 

and to submit results of postmarket 

surveillance and studies to FDA 

annually. FDA expects five respondents 

to carry out postmarket surveillance and 

studies annually. 

Because orders issued under section 

911(g) of the FD&C Act are valid for 

only a set number of years, FDA expects 

applicants will submit requests for 

renewal. Because the dates on which 

orders are issued and the length of the 

period for which the order is valid will 

vary, FDA expects one request for 

renewal annually. FDA estimates that it 

will take 1,000 hours to prepare the 

request for renewal. 

The estimated total burden hours for 

this collection of information is 

estimated to be 57,280. These burden 

estimates were computed using FDA 

staff expertise and by reviewing 

comments received from recent FDA 

information collections for other 

tobacco-related initiatives. In addition, 

FDA notes that due to the many 

similarities between the content 

requirements of sections 910(b)(1) (from 

PMTAs) and 911(d) (for MRTPAs) of the 

FD&C Act, and the likelihood that many 

respondents will submit joint PMTAs 

and MRTPAs, or cross-reference the 

applications, that part of the collection 

of information burden for respondents 

submitting an MRTPA will be captured 

in the preparation of the PMTA. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01121 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6879] 

Electronic Study Data Submission; 

Data Standards; Timetable for Updates 

to the Food and Drug Administration 

Data Standards Catalog for Study Data 

Submitted Electronically Under the 

Federal Food, Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the timetable for updates to 

the FDA Data Standards Catalog for 

study data submitted electronically in 

new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), biologics license applications 

(BLAs), and certain investigational new 

drug applications (INDs) to the Center 

for Biologics Evaluation and Research 

(CBER) and the Center for Drug 

Evaluation and Research (CDER). The 

initial implementation timetable for 

submitting standardized study data in 

electronic format was 24 months for 

NDAs, ANDAs, and applications, and 36 

months for certain INDs after 

publication of the final guidance 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized 

Study’’ in December 2014. When future 

updates to study data standards listed in 

the FDA Data Standards Catalog 

(Catalog) occur, these updated standards 

will be required in studies with a start 

date no earlier than 12 months after a 

Federal Register notice announcing 

such updates is published. When future 

new study data standards are listed in 

the Catalog, these new standards will be 

required in studies with a start date no 

earlier than 24 months after a Federal 

Register notice announcing such new 

standards is published. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 


sradovich on DSK3GMQ082PROD with NOTICES