Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35007 

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. 

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copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

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 that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Dina 

Zand, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5239, Silver Spring, 

MD 20993, 240–402–2538; or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Inborn Errors of Metabolism That Use 

Dietary Management: Considerations for 

Optimizing and Standardizing Diet in 

Clinical Trials for Drug Product 

Development.’’ This draft guidance 

describes FDA’s current 

recommendations regarding how to 

optimize and standardize dietary 

management in clinical trials for the 

development of drugs treating IEM for 

which dietary management is a key 

component of patients’ metabolic 

control. Optimizing dietary management 

in these patients before entry into and 

during the clinical trial(s) is essential to 

providing an accurate evaluation of the 

efficacy of new drug products. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on how sponsors can optimize and 

standardize dietary management for 

clinical trials in the development of 

drugs for inborn errors of metabolism 

that use dietary management. 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. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: July 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15777 Filed 7–23–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2733] 

Pharmacy Compounding 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 Pharmacy Compounding 

Advisory Committee (PCAC). The 

general function of the committee is to 

provide advice on scientific, technical, 

and medical issues concerning drug 

compounding under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act), 

and, as required, any other product for 

which FDA has regulatory 

responsibility, and to make appropriate 

recommendations to the Agency. The 

meeting will be open to the public. FDA 

is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

September 12, 2018, from 8 a.m. to 4:30 

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–2733. 

The docket will close on September 11, 

2018. Submit either electronic or 

written comments on this public 

meeting by September 11, 2018. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before September 11, 2018. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

September 11, 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 

August 28, 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 


jstallworth on DSKBBY8HB2PROD with NOTICES
35008 Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 

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–2733 for ‘‘Pharmacy 

Compounding 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 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: Jay 

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, PCAC@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: 

Background: Section 503A of the 

FD&C Act (21 U.S.C. 353a) describes the 

conditions that must be satisfied for 

human drug products compounded by a 

licensed pharmacist in a State licensed 

pharmacy or a Federal facility, or a 

licensed physician, to be exempt from 

the following three sections of the FD&C 

Act: (1) Section 501(a)(2)(B) (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice); (2) section 

502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use); and (3) 

section 505 (21 U.S.C. 355) (concerning 

the approval of human drug products 

under new drug applications or 

abbreviated new drug applications). 

One of the conditions that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that a bulk drug substance (active 

pharmaceutical ingredient) used in a 

compounded drug product must meet 

one of the following criteria: (1) 

Complies with the standards of an 

applicable United States Pharmacopoeia 

(USP) or National Formulary 

monograph, if a monograph exists, and 

the USP chapter on pharmacy 

compounding; (2) if an applicable 

monograph does not exist, is a 

component of a drug approved by the 

Secretary of Health and Human Services 

(the Secretary); or (3) if such a 

monograph does not exist and the drug 

substance is not a component of a drug 

approved by the Secretary, appears on a 

list developed by the Secretary through 

regulations issued by the Secretary (the 

‘‘503A Bulks List’’) (see section 

503A(b)(1)(A)(i) of the FD&C Act). 

Agenda: The committee will receive 

information on the following two issues 

to follow up on discussions from 

previous PCAC meetings: Balancing the 

criteria for the 503A bulk drug 

substance evaluation and compounding 

as it relates to dietary supplements. In 

addition, the committee will discuss six 

bulk drug substances nominated for 

inclusion on the 503A Bulks List. FDA 

will discuss the following nominated 

bulk drug substances: Alpha lipoic acid, 

coenzyme Q10, creatine monohydrate, 

pyridoxal 5 phosphate, choline 

chloride, and quercetin. The chart 

below identifies the use(s) FDA 

reviewed for each of the six bulk drug 

substances being discussed at this 

advisory committee meeting. The 

nominators of these substances will be 

invited to make a short presentation 

supporting the nomination. 

Drug Uses reviewed 

Alpha lipoic acid ................................. Diabetic neuropathy and associated pain, acute liver toxicity from Amanita spp. mushroom poisoning 

and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain. 

Coenzyme Q10 ................................... Mitochondrial disorders. 

Creatine monohydrate ........................ Mitochondrial disorders. 

Pyridoxal 5 phosphate ........................ Epilepsy and seizure disorders. 

Choline chloride .................................. Hepatic steatosis, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis. 


jstallworth on DSKBBY8HB2PROD with NOTICES
Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35009 

Drug Uses reviewed 

Quercetin ............................................ Asthma, allergy, cancer prevention and treatment, and hypertension. 

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 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

August 28, 2018, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 9:30 a.m. and 9:40 a.m., 

10:45 a.m. and 10:55 a.m., 11:50 a.m. 

and 12 noon, 1:50 p.m. and 2 p.m., 3:05 

p.m. and 3:15 p.m., and 4:10 p.m. and 

4:20 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 August 20, 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 August 21, 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 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: July 19, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15782 Filed 7–23–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2354] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Studies 

To Evaluate the Metabolism and 

Residue Kinetics of Veterinary Drugs 

in Food-Producing Species: Marker 

Residue Depletion Studies To 

Establish Product Withdrawal Periods 

in Aquatic Species; 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 (GFI) #257 

entitled ‘‘Studies to Evaluate the 

Metabolism and Residue Kinetics of 

Veterinary Drugs in Food-Producing 

Species: Marker Residue Depletion 

Studies to Establish Product Withdrawal 

Periods in Aquatic Species’’ (VICH 

GL57). This draft guidance has been 

developed for veterinary use by the 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH). 

This VICH draft guidance document is 

intended to provide study design 

recommendations that will facilitate the 

universal acceptance of the generated 

residue depletion data to fulfill the 

national/regional requirements. This 

draft guidance document provides 

recommendations on what should be 

included in a marker residue depletion 

study design for aquatic food-producing 

species. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 24, 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.’’ 


jstallworth on DSKBBY8HB2PROD with NOTICES