12502 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use for 

several years to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission, 

European Medicines Evaluation Agency, 

European Federation of Animal Health, 

Committee on Veterinary Medicinal 

Products, FDA, U.S. Department of 

Agriculture, the Animal Health 

Institute, Japanese Veterinary 

Pharmaceutical Association, Japanese 

Association of Veterinary Biologics, and 

Japanese Ministry of Agriculture, 

Forestry, and Fisheries. 

Six observers are eligible to 

participate in the VICH Steering 

Committee: One representative from the 

government of Australia/New Zealand, 

one representative from the industry in 

Australia/New Zealand, one 

representative from the government of 

Canada, one representative from the 

industry of Canada, one representative 

from the government of South Africa, 

and one representative from the 

industry of South Africa. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation for Animal Health (IFAH). 

An IFAH representative also 

participates in the VICH Steering 

Committee meetings. 

II. Revised Guidance on Studies To 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue 

Depletion Studies To Establish Product 

Withdrawal Periods 

In June 2014, the VICH Steering 

Committee agreed that a revised 

guidance document entitled ‘‘Studies to 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue 

Depletion Studies to Establish Product 

Withdrawal Periods’’ (VICH GL48(R)) 

should be made available to the public. 

The revised guidance is a revision of a 

final guidance on the same topic for 

which a notice of availability was 

published in the Federal Register of 

September 15, 2011 (76 FR 57056). The 

revised guidance includes minor 

changes that clarify recommendations 

for conducting a single timepoint study 

for products proposed for a 0-day 

withdrawal period or a 0-day milk 

discard time. In addition, the design for 

a 0-day milk discard timestudy was 

described, and a definition for 

preruminant was added. This revised 

guidance is a product of the Metabolism 

and Residue Kinetics Expert Working 

Group of the VICH. 

As part of the approval process for 

veterinary medicinal products in foodproducing animals, national/regional 

regulatory authorities require data from 

marker residue depletion studies in 

order to establish appropriate 

withdrawal periods in edible tissues, 

including meat, milk, and eggs. The 

objective of this guidance is to provide 

study design recommendations that will 

facilitate the universal acceptance of the 

generated residue depletion data to 

fulfill the national/regional 

requirements. 

III. Significance of Guidance 

As a result of Level 2 revisions, this 

VICH revised guidance is being issued 

in final, consistent with FDA’s good 

guidance practice (GGP) regulations at 

21 CFR 10.115(g)(4). This guidance, 

developed under the VICH process, has 

been revised to conform to FDA’s GGP 

regulation (21 CFR 10.115). For 

example, the document has been 

designated ‘‘guidance’’ rather than 

‘‘guideline.’’ In addition, guidance 

documents must not include mandatory 

language such as ‘‘shall,’’ ‘‘must,’’ 

‘‘require,’’ or ‘‘requirement,’’ unless 

FDA is using these words to describe a 

statutory or regulatory requirement. 

This VICH guidance represents the 

Agency’s current thinking on this topic. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of applicable statutes and 

regulations. 

IV. Paperwork Reduction Act of 1995 

This revised 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 514 have 

been approved under OMB control 

number 0910–0032. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to www.regulations.gov or 

written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http://

www.regulations.gov. 

VI. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

http://www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: March 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05345 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Bioequivalence 

Recommendations; Draft and Revised 

Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific bioequivalence (BE) 

recommendations. The 

recommendations provide productspecific guidance on the design of BE 

studies to support abbreviated new drug 

applications (ANDAs). In the Federal 

Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site. The BE 

recommendations identified in this 

notice were developed using the process 

described in that guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12503 

10.115(g)(5)), to ensure that the Agency 

considers your comments on these draft 

and revised draft guidances before it 

begins work on the final versions of the 

guidances, submit either electronic or 

written comments on the draft and 

revised draft product-specific BE 

recommendations listed in this notice 

by May 8, 2015. 

ADDRESSES: Submit written requests for 

single copies of the individual BE 

guidances 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. 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 

recommendations. 

Submit electronic comments on the 

draft product-specific BE 

recommendations to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4730, 

Silver Spring, MD 20993–0002, 301– 

796–5850. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

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

ComplianceRegulatoryInformation/

Guidances/default.htm. 

As described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific BE recommendations and 

provide a meaningful opportunity for 

the public to consider and comment on 

those recommendations. Under that 

process, draft recommendations are 

posted on FDA’s Web site and 

announced periodically in the Federal 

Register. The public is encouraged to 

submit comments on those 

recommendations within 60 days of 

their announcement in the Federal 

Register. FDA considers any comments 

received, and either publishes final 

recommendations or publishes revised 

draft recommendations for comment. 

Recommendations were last announced 

in the Federal Register on December 30, 

2014 (79 FR 78447). This notice 

announces draft product-specific 

recommendations, either new or 

revised, that are posted on FDA’s Web 

site. 

II. Drug Products for Which New Draft 

Product-Specific BE Recommendations 

Are Available 

FDA is announcing the availability of 

a new draft guidance for industry on 

product-specific BE recommendations 

for drug products containing the 

following active ingredients: 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR

DRUG PRODUCTS

A ..... Avanafil. 

Azilsartan medoxomil; Chlorthalidone. 

B ..... Buprenorphine hydrochloride; 

Naloxone hydrochloride. 

C ..... Chlorpheniramine maleate; Ibuprofen; 

Phenylephrine hydrochloride. 

Cyclosporine (multiple reference listed 

drugs). 

D ..... Deferiprone. 

Desoximetasone. 

Diclofenac. 

Dorzolamide. 

Doxepin hydrochloride. 

E ..... Eltrombopag olamine. 

Emtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarate. 

F ..... Flucinolone acetonide; Hydroquinone; 

Tretinoin. 

I ....... Ibrutinib. 

Ibuprofen. 

Ipratropium bromide. 

Isosorbide dinitrate. 

Isotretinoin. 

Ivacaftor. 

L ...... Loperamide hydrochloride (multiple 

reference listed drugs and dosage 

forms). 

M ..... Minocycline hydrochloride. 

N ..... Naproxen sodium; Diphenhydramine 

hydrochloride. 

O ..... Oseltamivir phosphate. 

Oxybutynin chloride. 

P ..... Potassium chloride. 

Praziquantel. 

Pyrimethamine. 

S ..... Sodium polystyrene sulfonate 

Spinosad. 

Sucroferric oxyhydroxide. 

T ..... Ticagrelor. 

Topiramate (multiple reference listed 

drugs). 

V ..... Vigabatrin. 

III. Drug Products for Which Revised 

Draft Product-Specific BE 

Recommendations Are Available 

FDA is announcing the availability of 

a revised draft guidance for industry on 

product-specific BE recommendations 

for drug products containing the 

following active ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS

FOR DRUG PRODUCTS

B ..... Brimonidine tartrate (multiple reference listed drugs). 

Brimonidine tartrate; Brinzolamide. 

Brinzolamide. 

Budesonide. 

C ..... Carbamazepine (multiple reference 

listed drugs and dosage forms). 

Ciprofloxacin; dexamethasone. 

D ..... Dexmethylphenidate hydrochloride. 

Dextroamphetamine sulfate. 

Doxepin hydrochloride. 

G ..... Gabapentin. 

I ....... Isotretinoin. 

M ..... Methylphenidate hydrochloride. 

Mirtazapine. 

N ..... Nisoldipine. 

P ..... Paliperidone. 

T ..... Teriflunomide. 

For a complete history of previously 

published Federal Register notices 

related to product-specific BE 

recommendations, go to http://

www.regulations.gov and enter Docket 

No. FDA–2007–D–0369. 

These draft and revised draft 

guidances are being issued consistent 

with FDA’s good guidance practices 

regulation (21 CFR 10.115). These 

guidances represent the Agency’s 

current thinking on product-specific 

design of BE studies to support ANDAs. 

They do not create or confer any rights 

for or on any person and do not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

IV. Comments 

Interested persons may submit either 

electronic comments on any of the 

specific BE recommendations posted on 

FDA’s Web site to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (see ADDRESSES). It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. The 

guidances, notices, and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

mstockstill on DSK4VPTVN1PROD with NOTICES

12504 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

1See Thompson v. Western States Med. Ctr., 535 

U.S. 357 (2002). 

will be posted to the docket at http://

www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: March 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05347 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0030] 

Compounding of Human Drug 

Products Under the Federal Food, 

Drug, and Cosmetic Act; 

Establishment of a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of public 

docket. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

establishing a public docket to receive 

information, recommendations, and 

comments on matters related to the 

Agency’s regulation of compounding of 

human drug products under sections 

503A and 503B of the Federal Food, 

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

This docket is intended for general 

comments related to human drug 

compounding that are not specific to 

documents or issues that are the subject 

of other dockets. 

DATES: Comments may be submitted to 

this docket at any time. 

ADDRESSES: You may submit comments, 

identified by Docket No. [FDA–2015–N– 

0030], by any of the following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written comments in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. [FDA–2015–N–0030]. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

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 Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Philantha Bowen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg.51, Rm. 5175, 

Silver Spring, MD 20993–0002, 301– 

796–2466. 

SUPPLEMENTARY INFORMATION: 

I. 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 or 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 drugs under 

new drug applications or abbreviated 

new drug applications). Previously, the 

conditions of section 503A of the FD&C 

Act also included restrictions on the 

advertising or promotion of the 

compounding of any particular drug, 

class of drug, or type of drug and the 

solicitation of prescriptions for 

compounded drugs. These provisions 

were challenged in court and held 

unconstitutional by the U.S. Supreme 

Court in 2002.1

On November 27, 2013, President 

Obama signed the Drug Quality and 

Security Act (DQSA) (Pub. L. 113–54), 

which contains important provisions 

relating to the oversight of human drug 

compounding. This new law removes 

from section 503A of the FD&C Act the 

provisions that had been held 

unconstitutional by the U.S. Supreme 

Court in 2002. By removing these 

provisions, the new law clarifies that 

section 503A of the FD&C Act applies 

nationwide. In addition, the DQSA adds 

a new section, 503B, to the FD&C Act 

(21 U.S.C. 353b) that creates a new 

category of ‘‘outsourcing facilities’’. 

Outsourcing facilities, as defined in 

section 503B of the FD&C Act, are 

facilities that meet certain conditions 

described in section 503B, including 

registration with FDA as an outsourcing 

facility. If these conditions are satisfied, 

a drug compounded for human use by 

or under the direct supervision of a 

licensed pharmacist in an outsourcing 

facility is exempt from three sections of 

the FD&C Act: (1) Section 502(f)(1), (2) 

section 505, and (3) section 582 (21 

U.S.C. 360eee), but not section 

501(a)(2)(B). 

Since enactment of the DQSA, FDA 

has sought public comment on a 

number of specific human drug 

compounding issues and has published 

several Federal Register notices seeking 

public input. These have included 

notices inviting comment on the 

registration process and product 

reporting requirements for human drug 

compounding outsourcing facilities (78 

FR 72899 and 78 FR 72897), requesting 

nominations for the list of drugs that 

present demonstrable difficulties for 

compounding (78 FR 72840), and 

seeking input on other specific matters. 

A complete list of the human drug 

compounding policy documents issued 

by the Agency for public comment can 

be found at http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Pharmacy

Compounding/ucm166743.htm. The 

Agency will continue to seek public 

comment on specific documents and 

issues through future Federal Register 

notices. The Agency recognizes, 

however, that it would be useful to have 

a docket available for submissions of 

any information related to human drug 

compounding that may be unrelated to 

the specific issues and documents 

published for public comment. 

II. Establishment of a Docket 

FDA is establishing a public docket so 

that anyone can share information, 

research, and ideas on any matters 

related to human drug compounding 

that are not specific to the documents or 

issues addressed in other dockets. This 

information will give the Agency insight 

into stakeholders’ experiences and 

views regarding human drug 

compounding as the Agency works to 

implement sections 503A and 503B of 

the FD&C Act. 

This docket will be open for comment 

simultaneously with a number of other 

dockets that are specific to particular 

human drug compounding documents 

or issues (see http://www.fda.gov/drugs/ 

mstockstill on DSK4VPTVN1PROD with NOTICES