80 FR 52756 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Electronic Exchange of Documents: Electronic File Format; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 169 (September 1, 2015)

Page Range		52756-52757
FR Document		2015-21582

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #225) entitled ``Electronic Exchange of Documents: Electronic File Format'' (VICH GL53). 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 cover the electronic file format specifications for individual documents and collections of multiple related documents that do not need subsequent modification during the regulatory procedure and are utilized for electronic exchange between industry and regulatory authorities in the context of regulatory approval of veterinary medicinal products.

Federal Register, Volume 80 Issue 169 (Tuesday, September 1, 2015)

[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52756-52757]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1177]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; 
Electronic Exchange of Documents: Electronic File Format; Guidance for 
Industry; 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 #225) entitled 
``Electronic Exchange of Documents: Electronic File Format'' (VICH 
GL53). 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 cover the electronic file format 
specifications for individual documents and collections of multiple 
related documents that do not need subsequent modification during the 
regulatory procedure and are utilized for electronic exchange between 
industry and regulatory authorities in the context of regulatory 
approval of veterinary medicinal products.

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 Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed 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 to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Scott Fontana, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0656, [email protected].

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; the 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 Federation for Animal 
Health (IFAH). An IFAH representative also participates in the VICH 
Steering Committee meetings.

II. Guidance on Electronic Exchange of Documents: Electronic File 
Format

    In the Federal Register of August 28, 2014 (79 FR 51342), FDA 
published a notice of availability for a draft guidance entitled 
``Electronic Exchange of Documents: Electronic File Format'' (VICH 
GL53) giving interested persons until October 27, 2014, to comment on 
the draft guidance. FDA received two comments on the draft guidance and 
those comments, as well as those received by other VICH member 
regulatory agencies, were considered as the guidance was finalized. The 
guidance announced in this notice finalizes the draft guidance dated 
August 2014. The final guidance is a product of the Electronic File 
Format Expert Working Group of the VICH.
    This VICH guidance document provides recommendations to industry 
regarding electronic file format specifications (e.g., file format, 
file size, file security, and cross-referencing) for individual 
documents and collections of multiple related documents for the 
transfer of electronic regulatory information in support of 
applications for the approval of veterinary medicinal products. This 
guidance applies to communication or data exchanged as documents in the 
context of all regulatory procedures where regulatory authorities 
accept electronic transfer of such documents. This can include but is 
not limited to applications for initial marketing authorizations, 
related pre-submission or post-authorization

[[Page 52757]]

procedures, applications for maximum residue limits, clinical trial 
applications, drug/active substance master files, or requests for 
regulatory or scientific advice.

III. Significance of Guidance

    This guidance, developed under the VICH process, has been revised 
to conform with FDA's good guidance practices regulation (21 CFR 
10.115). For example, the document has been designated ``guidance'' 
rather ``guideline''. In addition, guidance documents must not include 
mandatory language such as ``shall'', ``must'', ``require'', or 
``requirements'', unless FDA is using these words to describe a 
statutory or regulatory requirement. The guidance represents the 
current thinking of FDA on electronic exchange of documents: Electronic 
file format. 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 applicable statutes and regulations.

IV. 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 part 514 have been approved under 
OMB control number 0910-0032.

V. 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.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: August 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21582 Filed 8-31-15; 8:45 am]
BILLING CODE 4164-01-P

52756 Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices

requests should be identified by the title DATES: Submit either electronic or European Medicines Evaluation Agency;
of the information collection. Email written comments on Agency guidances European Federation of Animal Health,
address: infocollection@acf.hhs.gov. at any time. Committee on Veterinary Medicinal
OMB Comment: OMB is required to ADDRESSES: Submit written requests for Products; FDA; the U.S. Department of
make a decision concerning the single copies of this guidance to the Agriculture; the Animal Health
collection of information between 30 Policy and Regulations Staff (HFV–6), Institute; the Japanese Veterinary
and 60 days after publication of this Center for Veterinary Medicine, Food Pharmaceutical Association; the
document in the Federal Register. and Drug Administration, 7519 Standish Japanese Association of Veterinary
Therefore, a comment is best assured of Pl., Rockville, MD 20855. Send one self- Biologics; and the Japanese Ministry of
having its full effect if OMB receives it addressed adhesive label to assist that Agriculture, Forestry, and Fisheries.
office in processing your request. See Six observers are eligible to
within 30 days of publication. Written
the SUPPLEMENTARY INFORMATION section participate in the VICH Steering
comments and recommendations for the
for electronic access to the guidance Committee: One representative from the
proposed information collection should
document. government of Australia/New Zealand,
be sent directly to the following: Office
Submit electronic comments on the one representative from the industry in
of Management and Budget, Paperwork
guidance to http://www.regulations.gov. Australia/New Zealand, one
Reduction Project, Fax: 202–395–7285,
Submit written comments to the representative from the government of
Email: OIRA_SUBMISSION@
Division of Dockets Management (HFA– Canada, one representative from the
OMB.EOP.GOV, Attn: Desk Officer for industry of Canada, one representative
the Administration for Children and 305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, from the government of South Africa,
Families. and one representative from the
MD 20852.
Robert Sargis, industry of South Africa. The VICH
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Officer. Secretariat, which coordinates the
Scott Fontana, Center for Veterinary preparation of documentation, is
[FR Doc. 2015–21619 Filed 8–31–15; 8:45 am] Medicine (HFV–100), Food and Drug provided by the International
BILLING CODE 4184–01–P Administration, 7500 Standish Pl., Federation for Animal Health (IFAH).
Rockville, MD 20855, 240–402–0656, An IFAH representative also
scott.fontana@fda.hhs.gov. participates in the VICH Steering
DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION: Committee meetings.
HUMAN SERVICES
I. Background II. Guidance on Electronic Exchange of
Food and Drug Administration Documents: Electronic File Format
In recent years, many important
initiatives have been undertaken by In the Federal Register of August 28,
[Docket No. FDA–2014–D–1177] regulatory authorities and industry 2014 (79 FR 51342), FDA published a
associations to promote the notice of availability for a draft guidance
International Cooperation on
international harmonization of entitled ‘‘Electronic Exchange of
Harmonisation of Technical
regulatory requirements. FDA has Documents: Electronic File Format’’
Requirements for Registration of
participated in efforts to enhance (VICH GL53) giving interested persons
Veterinary Medicinal Products;
harmonization and has expressed its until October 27, 2014, to comment on
Electronic Exchange of Documents:
commitment to seek scientifically based the draft guidance. FDA received two
Electronic File Format; Guidance for
harmonized technical procedures for the comments on the draft guidance and
Industry; Availability
development of pharmaceutical those comments, as well as those
AGENCY: Food and Drug Administration, products. One of the goals of received by other VICH member
HHS. harmonization is to identify and then regulatory agencies, were considered as
reduce differences in technical the guidance was finalized. The
ACTION: Notice. requirements for drug development guidance announced in this notice
among regulatory agencies in different finalizes the draft guidance dated
SUMMARY: The Food and Drug countries. August 2014. The final guidance is a
Administration (FDA) is announcing the FDA has actively participated in the product of the Electronic File Format
availability of a guidance for industry International Conference on Expert Working Group of the VICH.
(GFI #225) entitled ‘‘Electronic Harmonisation of Technical This VICH guidance document
Exchange of Documents: Electronic File Requirements for Registration of provides recommendations to industry
Format’’ (VICH GL53). This guidance Pharmaceuticals for Human Use for regarding electronic file format
has been developed for veterinary use several years to develop harmonized specifications (e.g., file format, file size,
by the International Cooperation on technical requirements for the approval file security, and cross-referencing) for
Harmonisation of Technical of human pharmaceutical and biological individual documents and collections of
Requirements for Registration of products among the European Union, multiple related documents for the
Veterinary Medicinal Products (VICH). Japan, and the United States. The VICH transfer of electronic regulatory
This VICH guidance document is is a parallel initiative for veterinary information in support of applications
intended to cover the electronic file medicinal products. The VICH is for the approval of veterinary medicinal
format specifications for individual concerned with developing harmonized products. This guidance applies to
mstockstill on DSK4VPTVN1PROD with NOTICES

documents and collections of multiple technical requirements for the approval communication or data exchanged as
related documents that do not need of veterinary medicinal products in the documents in the context of all
subsequent modification during the European Union, Japan, and the United regulatory procedures where regulatory
regulatory procedure and are utilized for States, and includes input from both authorities accept electronic transfer of
electronic exchange between industry regulatory and industry representatives. such documents. This can include but is
and regulatory authorities in the context The VICH Steering Committee is not limited to applications for initial
of regulatory approval of veterinary composed of member representatives marketing authorizations, related pre-
medicinal products. from the European Commission, submission or post-authorization

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Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices 52757

procedures, applications for maximum DEPARTMENT OF HEALTH AND Counterterrorism and Emerging Threats,
residue limits, clinical trial HUMAN SERVICES Food and Drug Administration, 10903
applications, drug/active substance New Hampshire Ave., Bldg. 1, Rm.
master files, or requests for regulatory or Food and Drug Administration 4347, Silver Spring, MD 20993–0002,
scientific advice. [Docket No. FDA–2015–N–3042] 301–796–8510 (this is not a toll free
number).
III. Significance of Guidance
Authorization of Emergency Use of an SUPPLEMENTARY INFORMATION:
This guidance, developed under the In Vitro Diagnostic Device for
VICH process, has been revised to Detection of Middle East Respiratory I. Background
conform with FDA’s good guidance Syndrome Coronavirus; Availability Section 564 of the FD&C Act (21
practices regulation (21 CFR 10.115). U.S.C. 360bbb–3) as amended by the
AGENCY: Food and Drug Administration,
For example, the document has been Project BioShield Act of 2004 (Pub. L.
HHS.
designated ‘‘guidance’’ rather 108–276) and the Pandemic and All-
ACTION: Notice. Hazards Preparedness Reauthorization
‘‘guideline’’. In addition, guidance
documents must not include mandatory SUMMARY: The Food and Drug Act of 2013 (Pub. L. 113–5) allows FDA
language such as ‘‘shall’’, ‘‘must’’, Administration (FDA) is announcing the to strengthen the public health
‘‘require’’, or ‘‘requirements’’, unless issuance of an Emergency Use protections against biological, chemical,
FDA is using these words to describe a Authorization (EUA) (the Authorization) nuclear, and radiological agents. Among
statutory or regulatory requirement. The for an in vitro diagnostic device for other things, section 564 of the FD&C
guidance represents the current thinking detection of Middle East Respiratory Act allows FDA to authorize the use of
of FDA on electronic exchange of Syndrome Coronavirus (MERS-CoV). an unapproved medical product or an
documents: Electronic file format. It FDA issued this Authorization under unapproved use of an approved medical
does not establish any rights for any the Federal Food, Drug, and Cosmetic product in certain situations. With this
person and is not binding on FDA or the Act (the FD&C Act), as requested by EUA authority, FDA can help assure
public. You can use an alternative altona Diagnostics GmbH. The that medical countermeasures may be
approach if it satisfies the requirements Authorization contains, among other used in emergencies to diagnose, treat,
of applicable statutes and regulations. things, conditions on the emergency use or prevent serious or life-threatening
of the authorized in vitro diagnostic diseases or conditions caused by
IV. Paperwork Reduction Act of 1995 biological, chemical, nuclear, or
device. The Authorization follows the
This guidance refers to previously May 29, 2013, determination by the radiological agents when there are no
approved collections of information Department of Health and Human adequate, approved, and available
found in FDA regulations. These Services (HHS) Secretary that there is a alternatives.
collections of information are subject to significant potential for a public health Section 564(b)(1) of the FD&C Act
review by the Office of Management and emergency that has a significant provides that, before an EUA may be
Budget (OMB) under the Paperwork potential to affect national security or issued, the Secretary of HHS must
Reduction Act of 1995 (44 U.S.C. 3501– the health and security of U.S. citizens declare that circumstances exist
3520). The collections of information in living abroad and that involves MERS- justifying the authorization based on
21 CFR part 514 have been approved CoV. On the basis of such one of the following grounds: (1) A
under OMB control number 0910–0032. determination, the Secretary of HHS determination by the Secretary of
also declared on May 29, 2013, that Homeland Security that there is a
V. Comments circumstances exist justifying the domestic emergency, or a significant
authorization of emergency use of in potential for a domestic emergency,
Interested persons may submit either involving a heightened risk of attack
electronic comments regarding this vitro diagnostic devices for detection of
MERS-CoV subject to the terms of any with a biological, chemical, radiological,
document to http://www.regulations.gov or nuclear agent or agents; (2) a
or written comments to the Division of authorization issued under the FD&C
Act. The Authorization, which includes determination by the Secretary of
Dockets Management (see ADDRESSES). It Defense that there is a military
is only necessary to send one set of an explanation of the reasons for
issuance, is reprinted in this document. emergency, or a significant potential for
comments. Identify comments with the a military emergency, involving a
docket number found in brackets in the DATES: The Authorization is effective as
heightened risk to U.S. military forces of
heading of this document. Received of July 17, 2015.
attack with a biological, chemical,
comments may be seen in the Division ADDRESSES: Submit written requests for radiological, or nuclear agent or agents;
of Dockets Management between 9 a.m. single copies of the EUA to the Office (3) a determination by the Secretary of
and 4 p.m., Monday through Friday, and of Counterterrorism and Emerging HHS that there is a public health
will be posted to the docket at http:// Threats, Food and Drug Administration, emergency, or a significant potential for
www.regulations.gov. 10903 New Hampshire Ave., Bldg. 1, a public health emergency, that affects,
Rm. 4338, Silver Spring, MD 20993– or has a significant potential to affect,
VI. Electronic Access 0002. Send one self-addressed adhesive national security or the health and
Persons with access to the Internet label to assist that office in processing security of U.S. citizens living abroad,
may obtain the guidance at either your request or include a fax number to and that involves a biological, chemical,
which the Authorization may be sent.
mstockstill on DSK4VPTVN1PROD with NOTICES

http://www.fda.gov/cvm or http:// radiological, or nuclear agent or agents,
www.regulations.gov. See the SUPPLEMENTARY INFORMATION or a disease or condition that may be
section for electronic access to the attributable to such agent or agents; or
Dated: August 26, 2015. Authorization. (4) the identification of a material threat
Leslie Kux,
FOR FURTHER INFORMATION CONTACT: by the Secretary of Homeland Security
Associate Commissioner for Policy. Carmen Maher, Acting Assistant under section 319F–2 of the Public
[FR Doc. 2015–21582 Filed 8–31–15; 8:45 am] Commissioner for Counterterrorism Health Service (PHS) Act (42 U.S.C.
BILLING CODE 4164–01–P Policy and Acting Director, Office of 247d–6b) sufficient to affect national

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Document Created: 2018-02-26 10:04:34
Document Modified: 2018-02-26 10:04:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Scott Fontana, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0656, [email protected]
FR Citation		80 FR 52756

80 FR 52756 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Electronic Exchange of Documents: Electronic File Format; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 169 (September 1, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration