Anonymous ID: c6466c Nov. 13, 2020, 4:44 p.m. No.11634440   🗄️.is 🔗kun

>>11634275

POTUS has seemed like he understood that premise all along, but the pharmaturds are balls deep in the world population, and allowing a respectable pull out saving face for them is the best way forward so long as it isn't mandatory and the media finds something better to obsess about. Take the L like a champ and with dignity, Science.

Anonymous ID: c6466c Nov. 13, 2020, 5:01 p.m. No.11634693   🗄️.is 🔗kun

>>11634367

>>11634367

 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=11.3

 

[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2019]

[CITE: 21CFR11.3]

 

 

TITLE 21–FOOD AND DRUGS

CHAPTER I–FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

 

Subpart A - General Provisions

 

Sec. 11.3 Definitions.

(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.

 

(b) The following definitions of terms also apply to this part:

 

(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393)).

 

(2) Agency means the Food and Drug Administration.

 

(3) Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

 

(4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

 

(5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

 

(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

 

(7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

 

(8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

 

(9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

Anonymous ID: c6466c Nov. 13, 2020, 5:08 p.m. No.11634763   🗄️.is 🔗kun   >>4782 >>4818

Re: 11.3

'''As it relates to us/me/(you)

 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=11.3

 

[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2019]

[CITE: 21CFR11.3]

 

 

TITLE 21–FOOD AND DRUGS

CHAPTER I–FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

 

Subpart A - General Provisions

 

Sec. 11.3 Definitions.

(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.

 

(b) The following definitions of terms also apply to this part:

 

(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393)).

 

(2) Agency means the Food and Drug Administration.

 

(3) Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

 

(4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

 

(5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

 

(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

 

(7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

 

(8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

 

(9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.)

Anonymous ID: c6466c Nov. 13, 2020, 5:10 p.m. No.11634782   🗄️.is 🔗kun

>>11634763

Section 201

 

Section 201 Investigations

Under section 203 of the Trade Act of 1974, 19 U.S.C. § 2253, if the U.S. International Trade Commission transmits a report containing an affirmative finding of serious injury, the President shall take all appropriate and feasible action within his power that he determines will facilitate efforts by the domestic industry in question to make a positive adjustment to import competition and provide greater economic and social benefits than costs. USTR leads an interagency body in recommending to the President on the action to take.

 

Section 201 – Imported Solar Cells and Modules (Solar) (initiated May 17, 2017)

Section 201 – Imported Large Residential Washing Machines (Washers) (initiated June 5, 2017)

 

https://ustr.gov/issue-areas/enforcement/section-201-investigations

Anonymous ID: c6466c Nov. 13, 2020, 5:14 p.m. No.11634818   🗄️.is 🔗kun   >>4832 >>4908

>>11634763

11.4

 

§ 11.4 Other laws and regulations.

(a) The provisions of the Administrative Procedure Act generally applicable to agency adjudications (5 U.S.C. 554-557), and the Equal Access to Justice Act (5 U.S.C. 504) and its implementing regulations at 7 CFR part 1, subpart J, shall apply to proceedings under this part except for proceedings under § 11.5 and § 11.6(a).

 

(b) The Federal Rules of Evidence, 28 U.S.C. App., shall not apply to proceedings under this part.

 

[64 FR 33373, June 23, 1999, as amended at 74 FR 57401, Nov. 6, 2009]

 

>https://www.law.cornell.edu/cfr/text/7/11.4

Anonymous ID: c6466c Nov. 13, 2020, 5:22 p.m. No.11634908   🗄️.is 🔗kun

>>11634818

AGENCY:

Administrative Conference of the United States.

 

ACTION:

Notice of availability; Revised Model Rules for Implementation of the Equal Access to Justice Act.

 

SUMMARY:

The Office of the Chairman of the Administrative Conference of the United States is issuing these Revised Model Rules for Implementation of the Equal Access to Justice Act. These Revised Model Rules update the uniform procedures for the submission and consideration of applications for attorney fees under the Equal Access to Justice Act that were last issued in 1986. These Revised Model Rules reflect, among other things, amendments to the Act made by the Small Business Regulatory Enforcement Fairness Act and evolving adjudicative practices. They are designed to assist Federal agencies in adopting or modifying their own regulations for implementation of the Act.

 

FOR FURTHER INFORMATION CONTACT:

Alexandria Tindall Webb, Attorney Advisor, Administrative Conference of the United States, Suite 706 South, 1120 20th Street NW, Washington, DC 20036; Telephone 202-480-2080.

 

SUPPLEMENTARY INFORMATION:

The Administrative Conference Act, 5 U.S.C. 591-596, established the Administrative Conference of the United States. The Conference studies the efficiency, adequacy, and fairness of the administrative procedures used by Federal agencies and makes recommendations to agencies, the President, Congress, and the Judicial Conference of the United States for procedural improvements (5 U.S.C. 594(1)). For further information about the Conference and its activities, see www.acus.gov.