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  • Ea Final Guidance

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H (CDER) Center for Biologics Evaluation and Research (CBER) July 1998 CMC 6 Revision 1 Guidance for Industry Environmental Assessment of Human Drug and Biologics Applications Copies of this guidance are available from the Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, 5600 Fishers Lane, Rockville, MD 20857 (Phone 301-827-4573) or from the Internet at http://www.fda.gov/cder/guidance/index.htm. Copies also are available from the.

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An EA is to determine whether a specific threshold is crossed – the threshold of "significant" impact. An EIS simply has to reveal the impacts, not demonstrate that a threshold is or is not crossed.

General to Specific A change from a general to a specific indication for use is defined as: Any proposed increase in the level of specificity of the indication for use of a medical device.

A federal agency can determine that a Categorical Exclusion (CATEX) does not apply to a proposed action. The federal agency may then prepare an Environmental Assessment (EA). The EA determines whether or not a federal action has the potential to cause significant environmental effects.

If the EA concludes that no significant impacts will occur, a Finding of No Significant Impact (FONSI) is prepared.

FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR). FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency's current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA.

A guidance document is an agency statement of general applicability and future effect, other than a regulatory action, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.

Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.

Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232