Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42509 

Center’s website following the meeting: 

https://healthpolicy.duke.edu/events/ 

expanding-access-to-treatment-for-OUD. 

Webcast participants will be able to 

submit questions and comments via the 

webcast portal. Persons interested in 

participating in the live webcast must 

register online by September 19, 2018, 

by 5 p.m. Eastern Time (see Registration 

section above). Early registration is 

recommended because webcast 

connections are limited. Organizations 

are required to register all participants; 

however, we request that organizations 

view the meeting using one connection 

per location whenever possible. 

Other Issues for Consideration: All 

event materials will be provided to 

registered attendees via email prior to 

the meeting and will be made publicly 

available at the Duke-Margolis Center’s 

website: https://healthpolicy.duke.edu/ 

events/expanding-access-to-treatmentfor-OUD. A 1-hour lunch break is 

scheduled, but food will not be 

provided. There are multiple restaurants 

within walking distance of the 

Conference Center. 

IV. References 

The following references are on 

display in the Dockets Management 

Staff (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, and are 

available for viewing by interested 

persons between 9 a.m. and 4 p.m., 

Monday through Friday; they are also 

available electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Hedegaard, H., M. Warner, and A.M. 

Minin ̃ o, ‘‘Drug Overdose Deaths in the 

United States, 1999–2016,’’ NCHS Data 

Brief, no. 294, Hyattsville, MD: National 

Center for Health Statistics. 2017 

(available at https://www.cdc.gov/nchs/ 

products/databriefs/db294.htm), 

accessed June 27, 2018. 

2. Substance Abuse and Mental Health 

Services Administration, Center for 

Behavioral Health Statistics and Quality, 

‘‘Results from the 2016 National Survey 

on Drug Use and Health: Detailed 

Tables.’’ September 8, 2016 (available at 

https://www.samhsa.gov/data/sites/ 

default/files/NSDUH-DetTabs-2016/ 

NSDUH-DetTabs-2016.htm), accessed 

June 27, 2018. 

Dated: August 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18071 Filed 8–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0449] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Sun Protection 

Factor Labeling and Testing 

Requirements for Over-the-Counter 

Sunscreen Drug Products 

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 extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on sun protection 

factor (SPF) labeling and testing 

requirements for over-the-counter (OTC) 

sunscreen products containing specified 

ingredients and marketed without 

approved applications, and comments 

on compliance with Drug Facts labeling 

requirements for all OTC sunscreen 

products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 22, 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 October 22, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 22, 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– 

2011–N–0449 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Sun 

Protection Factor Labeling and Testing 

Requirements and Drug Facts Labeling 

for Over-the-Counter Sunscreen Drug 

Products.’’ 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 


amozie on DSK3GDR082PROD with NOTICES1
42510 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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, 

including each proposed extension of an 

existing 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. 

SPF Labeling and Testing Requirements 

for OTC Sunscreen Products—21 CFR 

201.327(a)(1) and (i), 21 CFR 201.66(c) 

and (d) 

OMB Control Number 0910–0717— 

Extension 

I. Background 

In the Federal Register of June 17, 

2011 (76 FR 35620), we published a 

final rule establishing labeling and 

effectiveness testing requirements for 

certain OTC sunscreen products 

containing specified active ingredients 

without approved applications (2011 

sunscreen final rule; § 201.327 (21 CFR 

201.327)). In addition to establishing 

testing requirements, the 2011 

sunscreen final rule lifted the delay of 

implementing the prior 1999 sunscreen 

final rule (published in the Federal 

Register of May 21, 1999 (64 FR 27666) 

and stayed in the Federal Register of 

December 31, 2001 (66 FR 67485) from 

complying with the 1999 Drug Facts 

labeling final rule (published in the 

Federal Register of March 17, 1999 (64 

FR 13254)), in which we amended our 

regulations governing requirements for 

human drug products to establish 

standardized format and content 

requirements for the labeling of all 

marketed OTC drug products in part 201 

(21 CFR part 201). Specifically, the 1999 

Drug Facts labeling final rule added new 

§ 201.66 to part 201. Section 201.66 

establishes content and format 

requirements for the Drug Facts portion 

of OTC drug product labels. We 

specifically exempted OTC sunscreen 

products from complying with the 1999 

Drug Facts labeling final rule until we 

lifted the stay of the 1999 sunscreen 

final rule. The 2011 sunscreen final rule 

became effective December 17, 2012, for 

sunscreen products with annual sales of 

$25,000 or more and December 17, 

2013, for sunscreen products with 

annual sales of less than $25,000 when 

we published an extension date notice 

in the Federal Register of May 11, 2012 

(77 FR 27591) (2012 extension date 

notice). 

II. SPF Labeling and Testing for OTC 

Sunscreens Containing Specified Active 

Ingredients and Marketed Without 

Approved Applications 

In the Federal Register of June 17, 

2011 (76 FR 35678), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information regarding SPF labeling and 

testing requirements for OTC sunscreen 

products containing specified 

ingredients and marketed without 

approved applications (2011 60-day 

notice). In that notice, we stated that 

§ 201.327(a)(1) requires the principal 

display panel (PDP) labeling of a 

sunscreen covered by the 2011 

sunscreen final rule to include the SPF 

value determined by conducting the 

SPF test outlined in § 201.327(i). 

Therefore, that provision resulted in an 

information collection with a thirdparty disclosure burden for 

manufacturers of OTC sunscreens 

covered by the 2011 sunscreen rule. We 

determined that products need only 

complete the testing and labeling 

required by the 2011 sunscreen rule 

once and then continue to use the 

resultant labeling (third-party 

disclosure) going forward without 

additional burden. This one-time testing 

would need to be conducted within the 

first 3 years after publication of the 2011 

sunscreen final rule for all OTC 

sunscreens covered by that rule. 

We determined that the third-party 

disclosure burden by manufacturers of 

OTC sunscreens covered by the 2011 

sunscreen rule was based on: (1) An 

estimate of the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each collection of 

information; (2) the conduct of SPF 

testing based on the estimated number 

of existing formulations; (3) an estimate 

of the time to relabel currently marketed 

OTC sunscreens containing specified 

ingredients and marketed without 

approved applications; and (4) testing 

and labeling of new products 

introduced each year. The estimate for 

this burden in the 2011 60-day notice 

was a total of 30,066 hours in years 1 

and 2, and a total of 966 in each 

subsequent year. 

All currently marketed OTC 

sunscreen drug products are already 

required to comply with the SPF 

labeling requirements specified by the 

2011 sunscreen final rule. However, our 

original estimate also included the 

burden of new products introduced 

each year. We estimated that as many as 


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60 new OTC sunscreen products stock 

keeping units (SKUs) may be introduced 

each year, which must be tested and 

labeled with the SPF value determined 

in the test. We estimated that the 60 

new sunscreen SKUs represent 39 new 

formulations. The burden for testing and 

labeling these formulations was 

estimated at 30 hours per year. 

We received only two comments on 

our estimated information collection 

burden (FDA–2011–N–0449–0002 and 

FDA–2011–N–0449–0003). These 

comments were already addressed in 

FDA’s notice entitled ‘‘Agency 

Information Collection Activities; 

Submission for Office of Management 

and Budget Review; Comment Request; 

Sun Protection Factor Labeling and 

Testing Requirements and Drug Facts 

Labeling for Over-the Counter 

Sunscreen Drug Products’’ published in 

the Federal Register of May 9, 2012 (77 

FR 27230). 

In the Federal Register of April 16, 

2015 (80 FR 20499), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number 

of respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Conduct SPF testing in accordance with 

§ 201.327(i) for new sunscreens.

20 1.95 39 24 ................................... 936 

Create PDP labeling in accordance with 

§ 201.327(a)(1) for new sunscreen SKUs.

20 3 60 0.5 (30 minutes) ............. 30 

Total ............................................................. ........................ ........................ ........................ ........................................ 966 

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

III. Drug Facts Labeling for OTC 

Sunscreens 

Because the 2011 sunscreen final rule 

also lifted the delay of implementing the 

Drug Facts regulations (§ 201.66) for 

OTC sunscreens, the rule also modified 

the information collection associated 

with § 201.66 (currently approved under 

OMB control number 0910–0340) and 

added a third-party disclosure burden 

resulting from requiring OTC sunscreen 

products to comply with Drug Facts 

regulations. In the 1999 Drug Facts 

labeling final rule, we amended our 

regulations governing requirements for 

human drug products to establish 

standardized format and content 

requirements for the labeling of all 

marketed OTC drug products, codified 

in § 201.66. This section establishes 

requirements for the Drug Facts portion 

of labels on OTC drug products 

requiring such labeling, to include 

uniform headings and subheadings, 

presented in a standardized order with 

minimum standards for type size and 

other graphical features. Therefore, OTC 

sunscreen products already on the 

market at that time incurred a one-time 

burden to comply with the requirements 

in § 201.66(c) and (d). In the 60-day 

notice, the burden was estimated as 

43,200 hours for existing sunscreen 

SKUs and 720 hours for new sunscreen 

SKUs. 

The compliance dates for the 2011 

sunscreen final rule that lifted the delay 

of the § 201.66 labeling implementation 

data for OTC sunscreen products were 

December 17, 2012, for sunscreen 

products with annual sales of $25,000 or 

more and December 17, 2013, for 

sunscreen products with annual sales of 

less than $25,000, respectively, when 

we published the 2012 extension date 

notice. All currently marketed 

sunscreen products are, therefore, 

already required to comply with the 

Drug Facts labeling requirements in 

§ 201.66 and will incur no further 

burden in the 1999 Drug Facts labeling 

final rule. However, new OTC sunscreen 

drug products will be subject to a onetime burden to comply with Drug Facts 

labeling requirements in § 201.66. In the 

2011 60-day notice, we estimated that as 

many as 60 new product SKUs marketed 

each year must comply with Drug Facts 

regulations. We estimated that these 60 

SKUs would be marketed by 30 

manufacturers, which will spend 

approximately 12 hours on each label 

based on the most recent estimate used 

for other OTC drug products to comply 

with the 1999 Drug Facts labeling final 

rule, including public comments 

received on this estimate in 2010 that 

addressed sunscreens. This is equal to 

720 hours annually (60 SKUs, 12 hours 

per SKU). We stated that we do not 

expect any OTC sunscreens to apply for 

exemptions or deferrals of the Drug 

Facts regulations in § 201.66(e). 

However, we considered this in 2013 

and estimated the burden for an 

exemption or deferral by considering 

the number of exemptions or deferrals 

we have received since publication of 

the 1999 Drug Facts labeling final rule 

(one response) and estimating that a 

request for deferral or exemption would 

require 24 hours to complete. 

Multiplying the annual frequency of 

response (0.125) by the number of hours 

per response (24) gives a total response 

time for requesting an exemption or 

deferral equal to 3 hours. 

FDA estimates the burden of this 

collection of information as follows: 


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TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number 

of respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Format labeling in accordance with § 201.66(c) and (d) for 

new sunscreen SKUs ....................................................... 20 3 60 12 720 

Request for Drug Facts exemption or deferral § 201.66(e) 1 0.125 0.125 24 3 

Total .............................................................................. ........................ ........................ ........................ ........................ 723 

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

We note that these estimates may be 

adjusted in the future development of 

an upcoming rulemaking on over-thecounter sunscreen products (RIN 0910– 

AA01). FDA intends to amend this 

information collection and/or seek 

approval of additional information 

collections, as appropriate, concurrent 

with this rulemaking. 

Dated: August 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18073 Filed 8–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2018–P–1335 and FDA– 

2018–P–1361] 

Determination That DITROPAN XL 

(Oxybutynin Chloride) Extended 

Release Tablets, 15 Milligrams, Were 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that DITROPAN XL 

(oxybutynin chloride) Extended Release 

Tablets, 15 milligrams (mg), were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for DITROPAN 

XL (oxybutynin chloride) Extended 

Release Tablets, 15 mg, if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: Glen 

Cheng, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6210, Silver Spring, 

MD 20993–0002, 301–796–1494. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 5 mg, 10 mg, 

and 15 mg, are the subject of NDA 

020897, held by Janssen 

Pharmaceuticals Inc., and initially 

approved on December 16, 1998. 

DITROPAN XL is indicated for the 

treatment of overactive bladder with 

symptoms of urge urinary incontinence, 

urgency, and frequency, and for the 

treatment of pediatric patients aged 6 

years and older with symptoms of 

detrusor overactivity associated with a 

neurological condition (e.g., spina 

bifida). 

In a letter dated December 14, 2017, 

Janssen Pharmaceuticals Inc. notified 

FDA that DITROPAN XL (oxybutynin 

chloride) Extended Release Tablets, 15 

mg, were being discontinued, and FDA 

moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. Although 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 5 mg and 10 

mg, were also previously listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book, they are 

now listed in the ‘‘Prescription Drug 

Product List’’ section of the Orange 

Book. 

Hyman, Phelps & McNamara, P.C., 

submitted a citizen petition dated 

March 30, 2018 (Docket No. FDA–2018– 

P–1335), and Ajanta Pharma Limited 

submitted a citizen petition dated April 

2, 2018 (Docket No. FDA–2018–P– 

1361), under 21 CFR 10.30, requesting 

that the Agency determine whether 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 5 mg, 10 mg, 

and 15 mg, were withdrawn from sale 

for reasons of safety or effectiveness. 

As noted, DITROPAN XL (oxybutynin 

chloride) Extended Release Tablets, 5 

mg and 10 mg, are no longer listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book, and 

therefore we need not determine 

whether they were withdrawn from sale 

for reasons of safety or effectiveness. 

With regard to DITROPAN XL 

(oxybutynin chloride) Extended Release 

Tablets, 15 mg, after considering the 

citizen petition and reviewing Agency 

records, and based on the information 

we have at this time, FDA has 

determined under § 314.161 that 

DITROPAN XL (oxybutynin chloride) 

Extended Release Tablets, 15 mg, were 

not withdrawn from sale for reasons of 

safety or effectiveness. The petitioners 

have identified no data or other 

information suggesting that this drug 


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