73322 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 

presiding officer may omit a 

participant’s appearance. 

The presiding officer and other 

participants will use the collected 

information in a hearing to identify 

specific interests to be presented. This 

preliminary information serves to 

expedite the prehearing conference and 

commits participation. 

The respondents are individuals or 

households, State or local governments, 

not-for-profit institutions and 

businesses, or other for-profit groups 

and institutions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.30—Citizen Petition ........................................................ 207 1 207 24 4,968 

10.33—Administrative reconsideration of action ................. 4 1 4 10 40 

10.35—Administrative Stay of Action .................................. 5 1 5 10 50 

10.85—Advisory Opinions ................................................... 4 1 4 16 64 

12.22—Filing Objections and Requests for a Hearing on a 

Regulation or Order .......................................................... 3 1 3 20 60 

12.45—Notice of Participation ............................................. 4 1 4 3 12 

Total .............................................................................. 5,194 

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

The burden estimates for this 

collection of information are based on 

Agency records and experience over the 

past 3 years. 

Dated: December 4, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28825 Filed 12–9–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1067] 

Patient Counseling Information 

Section of Labeling for Human 

Prescription Drug and Biological 

Products—Content and Format; 

Guidance 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 a 

guidance for industry entitled ‘‘Patient 

Counseling Information Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ The recommendations in this 

guidance are intended to assist 

applicants in developing the ‘‘Patient 

Counseling Information’’ section of 

labeling and to help ensure that this 

section of labeling is clear, useful, 

informative, and to the extent possible, 

consistent in content and format. This 

guidance finalizes the draft guidance 

issued on September 18, 2013. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this 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, or 

the 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 guidance document. 

Submit electronic comments on the 

guidance 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: 

Jonas Santiago, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6348, 

Silver Spring, MD 20993–0002, 301– 

796–5346; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Patient 

Counseling Information Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ This guidance is intended to 

assist applicants in developing the 

Patient Counseling Information section 

of labeling required under 21 CFR 

201.57(c)(18). Recommendations 

include the following: (1) How to decide 

what topics to include in the section, (2) 

how to present information within the 

section, and (3) how to format and 

organize section contents. 

This guidance is one of a series of 

guidances FDA is developing, or has 

developed, to assist applicants with the 

content and format of labeling for 

human prescription drug and biological 

products. In the Federal Register of 

January 24, 2006 (71 FR 3922), FDA 

published a final rule on labeling for 

human prescription drug and biological 

products. The final rule and additional 

guidances can be accessed at http://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/

LawsActsandRules/ucm084159.htm. 

The labeling requirements and these 

guidances are intended to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use. 

This guidance finalizes the draft 

guidance issued on September 18, 2013 

(78 FR 57394). FDA reviewed all 

received comments carefully during the 

finalization of the guidance. Other than 

clarifying edits, no changes of 

significance were made to the final 

version of the guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73323 

current thinking on the content and 

format of the Patient Counseling 

Information section of labeling for 

human prescription drug and biological 

products. 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 the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document 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. 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. 

III. The Paperwork Reduction Act of 

1995 

This 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 201.56 and 201.57 have been 

approved under OMB control number 

0910–0572. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http://

www.regulations.gov. 

Dated: December 4, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28888 Filed 12–9–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0588] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; 

Guidance for Industry on 

Pharmacovigilance of Veterinary 

Medicinal Products: Electronic 

Standards for Transfer of Data; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

(GFI #214) entitled ‘‘Pharmacovigilance 

of Veterinary Medicinal Products: 

Electronic Standards for Transfer of 

Data’’ (VICH GL35). This 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 guidance document is 

intended to provide recommended 

standards to construct a single Adverse 

Event Report (AER) electronic message 

to transmit VICH GL42 contents to all 

member regions and Product Problem 

Reports (PPR) to FDA for veterinary 

medicinal products. Please note that 

VICH GL42 has been harmonized in GFI 

#188, ‘‘Data Elements for Submission of 

Veterinary Adverse Event Reports to the 

Center for Veterinary Medicine.’’ 

DATES: Submit either electronic or 

written comments on Agency guidance 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Margarita Brown, Center for Veterinary 

Medicine (HFV–240), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9048, 

CVMAESupport@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote the 

international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based, 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify, and then 

reduce, differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

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, the Japanese Veterinary 

Pharmaceutical Association, the 

Japanese Association of Veterinary 

Biologics, and the 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 

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