2794 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

compounder has the option of not filling 

a prescription with a compounded drug 

if a prescriber determination is not 

provided. 

Issue Five: One commenter stated that 

requiring a notation on the prescription 

that a compounded drug was on the 

drug shortage list when compounded, 

and the date the list was checked, 

would be overly burdensome. 

FDA Response to Issue Five: FDA 

does not believe this presents a 

significant burden, as a compounder 

that wants to rely on a drug shortage to 

establish that a compounded drug is not 

essentially a copy of a commercially 

available drug would need to check 

FDA’s shortage website. Noting the date 

the list was checked is not onerous, and 

is necessary for FDA to verify 

compliance during inspections. FDA 

estimates this activity would take 2 

minutes. 

Issue Six: One commenter requested 

clarity on how long records should be 

maintained; what specific information 

should be maintained; and when such 

records should be presented to FDA. 

FDA Response to Issue Six: FDA has 

revised the guidance to include a 

recommended duration of 3 years for 

maintaining records. The guidance 

describes the records that can be 

retained to demonstrate compliance. 

FDA may request to review such records 

during establishment inspections. 

FDA estimates the burden of this 

collection of information as follows: 

We estimate that annually a total of 

approximately 6,888 compounders 

(‘‘number of respondents’’ in table 1, 

line 1) will consult a prescriber to 

determine whether he or she has made 

a determination that the compounded 

drug has a change that produces a 

significant difference for a patient as 

compared to the comparable 

commercially available drug, and that 

the compounders will document this 

determination on approximately 

172,200 prescription orders for 

compounded drugs (‘‘total annual 

disclosures’’ in table 1, line 1). We 

estimate that the consultation between 

the compounder and the prescriber and 

adding a notation to each prescription 

that does not already document this 

determination will take approximately 3 

minutes per prescription order. 

In addition, we estimate that a total of 

approximately 6,888 compounders 

(‘‘number of respondents’’ in table 1, 

line 2) will document this information 

on approximately 344,400 prescription 

orders for compounded drugs (‘‘total 

annual disclosures’’ in table 1, line 2). 

We estimate that checking FDA’s drug 

shortage list and documenting this 

information will take approximately 2 

minutes per prescription order. 

We estimate that a total of 

approximately 3,444 compounders 

(‘‘number of recordkeepers’’ in table 2) 

will keep approximately 165,312 

records (‘‘total annual records’’). We 

estimate that maintaining the records 

will take approximately 2 minutes per 

record. 

TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1

Type of reporting Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden per 

disclosure Total hours 

Consultation between the compounder and prescriber and the notation on the prescription documenting the prescriber’s determination of significant difference.6,888 50 344,400 0.05 (3 minutes) ....... 17,220 

Checking FDA’s drug shortage list and documenting on the prescription that the drug is in 

shortage.

6,888 50 344,400 0.03 (2 minutes) ....... 10,332 

Total ................................................................... ........................ ........................ ........................ ................................... 27,552 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Records of frequency and number of prescriptions 

filled for compounded drugs that are essentially a 

copy.

3,444 48 165,312 0.03 (2 minutes) ....... 4,959 

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

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00917 Filed 1–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0055] 

Gastrointestinal Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Gastrointestinal Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2795 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

March 8, 2018, from 8 a.m. to 5 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–0055. 

The docket will close on March 7, 2018. 

Submit either electronic or written 

comments on this public meeting by 

March 7, 2018. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 7, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 7, 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. 

Comments received on or before 

February 22, 2018, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by FDA. 

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, 

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– 

2018–N–0055 for ‘‘Gastrointestinal 

Drugs Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

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.’’ FDA 

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 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 the 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: Jay 

R. Fajiculay, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, Fax: 

301–847–8533, email: GIDAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committee will discuss 

supplemental new drug application 

(sNDA) 203214 supplement 18, 

XELJANZ (tofacitinib) tablets, submitted 

by Pfizer Inc., proposed for the 

treatment of adult patients with 

moderately to severely active ulcerative 

colitis who have demonstrated an 

inadequate response, loss of response, 

or intolerance to corticosteroids, 

azathioprine, 6-mercaptopurine, or 

tumor necrosis factor inhibitor therapy. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 


daltland on DSKBBV9HB2PROD with NOTICES
2796 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 7, 2018. Oral 

presentations from the public will be 

scheduled between approximately 12:40 

p.m. and 1:40 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

13, 2018. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 14, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jay R. 

Fajiculay (See, FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00903 Filed 1–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6969] 

Product Title and Initial U.S. Approval 

in Highlights for Human Prescription 

Drug and Biological Products— 

Content and Format; 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 

guidance for industry entitled ‘‘Product 

Title and Initial U.S. Approval in the 

Highlights of Prescribing Information for 

Human Prescription Drug and Biological 

Products—Content and Format.’’ The 

labeling regulations for human drug and 

biological products require that the 

Highlights of Prescribing Information 

(Highlights) contain a product title and 

the year of initial U.S. approval. This 

draft guidance provides 

recommendations on the content and 

format of the product title and initial 

U.S. approval to bring greater 

consistency to the presentation of these 

required elements and to help ensure 

these elements provide clear and useful 

information to the health care provider. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 20, 2018 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– 

2017–D–6969 for ‘‘Product Title and 

Initial U.S. Approval in Highlights for 

Human Prescription Drug and Biological 

Products—Content and Format; 

Guidance for Industry; Availability.’’ 

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. 

• 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 


daltland on DSKBBV9HB2PROD with NOTICES