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1 312.31 - CFR - Code of Federal Regulations Title 21 - FDA
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.31
An information amendment is required to bear prominent identification of its contents (e.g., "Information Amendment: Chemistry, Manufacturing, and Control", " ...
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2 Code of Federal Regulations | GovInfo
https://www.govinfo.gov/help/cfr
(2) Reference, if necessary, to specific technical information in the IND or in a concurrently submitted information amendment to the IND that the spon-.
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3 Public Information - Federal Register
https://www.federalregister.gov/documents/2022/09/13/2022-19736/public-information
The amendment to 21 CFR 20.33 requires FDA to include in FOIA response letters the contact information for the Office of Government Information ...
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4 21 CFR Ch. I (4–1–10 Edition) § 312.31
https://www.gpo.gov/fdsys/pkg/CFR-2010-title21-vol5/pdf/CFR-2010-title21-vol5-sec312-31.pdf
21 CFR Ch. I (4–1–10 Edition). § 312.31 submission that contained the pro- ... tocol, and all additional information ... 312.31 Information amendments.
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5 Required Amendments and Reports to a FDA-Accepted ...
https://research.vcu.edu/media/office-of-research-and-innovation/clinical/IND_required_amendments_and_reports.pdf
A. Protocol Amendments [21 CFR 312.30]. ... B. Information Amendments [21 CFR 312.31]. ... Examples Information Amendments .
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6 FDAAA 801 and the Final Rule - ClinicalTrials.gov
https://clinicaltrials.gov/ct2/manage-recs/fdaaa
42 CFR 11.20 Who must submit clinical trial registration information? ... the FD&C Act (PDF) as amended by Section 307 of FDAAA are considered ACTs and must ...
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7 Drugs IND Maintenance - ReGARDD
https://www.regardd.org/drugs/ind-maintenance
Information Amendments (21 CFR 312.31 ) · Submitted as necessary but not more than every 30 days, if feasible · The amendment should clearly: Identify its ...
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8 2019-02-21 Energy Conservation Program ... - Regulations.gov
https://www.regulations.gov/document/EERE-2012-BT-TP-0013-0041
This correction republishes amendments from both rulemakings that could not be incorporated into the Code of Federal Regulations (CFR) due to inaccurate ...
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9 Understanding FDA Regulatory Requirements for ... - NCBI
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435682/
Information Amendments (21 CFR 312.31). Similar to amendments in the research protocol, changes in the essential information regarding the IND that are not ...
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10 34 C.F.R. Part 106 - Department of Education
https://www2.ed.gov/policy/rights/reg/ocr/edlite-34cfr106.html
Regulation implementing Title IX of the Education Amendments of 1972. ... Such notification shall contain such information, and be made in such manner, ...
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11 Americans with Disabilities Act of 1990, As Amended | ADA.gov
https://www.ada.gov/law-and-regs/ada/
12101 note: Findings and Purposes of ADA Amendments Act of 2008, Pub. ... (B) information obtained regarding the medical condition or history of the ...
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12 Reporting New Information to the FDA and the Sponsor
https://ssri.psu.edu/clinicalresearchguidebook/reporting-new-information-fda-and-sponsor
FDA does not issue “permissions” or “approvals” for protocol amendments, your changes are effective immediately upon the receipt of your amendment by the FDA.
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13 Wages and the Fair Labor Standards Act
https://www.dol.gov/agencies/whd/flsa
More information about the rule can be found here. ... Type of Violation, Statutory Citation, CFR Citation, Maximum Civil Monetary Penalty on or before ...
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14 USPTO fee schedule
https://www.uspto.gov/learning-and-resources/fees-and-payment/uspto-fee-schedule
› fees-and-payment › uspto-fee-...
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15 HIPAA for Professionals - HHS.gov
https://www.hhs.gov/hipaa/for-professionals/index.html
This Rule set national standards for the protection of individually identifiable health information by three types of covered entities: health plans, health ...
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16 All Forms - USCIS
https://www.uscis.gov/forms/all-forms
You may obtain a copy of your own FBI record using the procedures outlined at 28 CFR 16.30-16.34. For more information, please visit: ...
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17 Complying with COPPA: Frequently Asked Questions
https://www.ftc.gov/business-guidance/resources/complying-coppa-frequently-asked-questions
The Commission published an amended Rule on January 17, 2013. ... over what information is collected from their young children online.
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18 2020 Compliance Supplement Addendum - The White House
https://www.whitehouse.gov/wp-content/uploads/2020/12/2020-Compliance-Supplement-Addendum_Final.pdf
This addendum supplements the 2020 OMB 2 CFR 200 Part 200, Appendix XI ... An update to Part 5 showing information relating to COVID-19 ...
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19 FEC: Home
https://www.fec.gov/
The Federal Election Campaign Act of 1971, as amended (52 U.S.C. §§30101-30146). 11 CFR 100.18. Prior to September 1, 2014, the Act appeared in Title 2 of the ...
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20 FDA 21 CFR Part 11 compliance: How to protect your scientific ...
https://www.colabra.app/blog/fda-21-cfr-part-11-compliance-protect-scientific-intellectual-property/
Any additions, deletions, or amendments to a previously entered record should not overwrite the record. Instead, any changes to a previously-entered document ...
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21 Updating Your Registration or Authority | FMCSA
https://www.fmcsa.dot.gov/registration/updating-your-registration
Biennial Updates. Federal Motor Carrier Safety Administration (FMCSA) requires all entities under its jurisdiction to update their information every two years.
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22 APA Legal References - Purdue OWL
https://owl.purdue.edu/owl/research_and_citation/apa_style/apa_formatting_and_style_guide/apa_legal%20references%20.html
CFR here stands for the Code of Federal Regulations. ... When citing particular articles and amendments, create reference list entries and in-text citations ...
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23 Code of Federal Regulations / CFR (CongressionalGlossary ...
https://hobnobblog.com/2012/04/code-of-federal-regulations-cfr-congressionalglossary-com/
To assist the user between revisions, there is the List of CFR Sections Affected (LSA), which shows amendments published in the Federal Register and not yet ...
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24 Continuum of Care (CoC) Program - HUD Exchange
https://www.hudexchange.info/programs/coc/
Log in to your e-snaps account and make sure your Applicant Profile is updated. HMIS: Homeless Management Information System ... Grant Agreement Amendments.
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25 danaher corporation - SEC.gov
https://www.sec.gov/Archives/edgar/data/313616/000031361620000065/dhr-202032x8k.htm
... pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ... inline XBRL with applicable taxonomy extension information contained in Exhibits 101) ...
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26 IRS Privacy Policy | Internal Revenue Service
https://www.irs.gov/privacy-disclosure/irs-privacy-policy
To amend a federal tax record, taxpayers must file Form 1040-X or follow IRS procedures for other changes, such as change of address. The ...
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27 IND Protocol Amendments
https://www.ctsi.ufl.edu/research/research-support/irb-consults/investigational-new-drug-applications-and-reporting-responsibilities/ind-protocol-amendments/
Protocol Amendment: Change in a Protocol Information Sheet: The information sheet must provide 1) a brief description of the change, and 2) reference (date and ...
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28 VA-SPORTS-21-NOFO.pdf - Veterans Affairs
https://www.blogs.va.gov/nvspse/wp-content/uploads/2021/01/VA-SPORTS-21-NOFO.pdf
FOR FURTHER INFORMATION CONTACT: Veterans Health Administration (VHA) ... Adaptive Sports Grant Program by regulation in 38 CFR Part 77. Funds made.
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29 KanCare
https://kancare.ks.gov/
Information about the when and where the public hearings will be held can be located below. ... KanCare 2.0 COVID-19 PHE Amendment Evaluation Design ...
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30 Updating Regulations from the CFR -- By Susan M Boland
https://uc.mediaspace.kaltura.com/media/1_fps8ul2i
Note that the e-CFR does not contain proposed amendments. The official publication of Federal rules is the Code of Federal Regulations that ...
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31 Does HUD Owe You A Refund?
https://entp.hud.gov/dsrs/refunds/
By accessing this information, you agree to the Rules of Behavior for this system and ... Public Law 89-174; 24 CFR 5.210; 24 CFR 200.1101; 24 CFR 203.35
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32 Privacy Impact Assessment - Department of Justice
https://www.justice.gov/d9/2022-11/usms_pia_vrs_2022_final.pdf
personally identifiable information (PII) by BWCs and the retention of said ... information and records, to include the DOJ Touhy Regulations, 28 C.F.R. ...
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33 Proposed Amendment to Federal Acquisition Regulation ...
https://www.gibsondunn.com/proposed-amendment-to-federal-acquisition-regulation-would-require-contractors-to-disclose-greenhouse-gas-emissions-reduction-climate-based-financial-risks/
[22] 48 C.F.R. § 9.103(a) (“Purchases shall be made from, and contracts shall be awarded to, responsible prospective contractors only.”) [23] ...
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34 Moody's affirms LifePoint's B2 CFR, revises the outlook to ...
https://www.moodys.com/research/Moodys-affirms-LifePoints-B2-CFR-revises-the-outlook-to-negative--PR_471544
For further information please see the issuer/deal page for the respective ... and issued with no amendment resulting from that disclosure.
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35 National Flood Hazard Layer | FEMA.gov
https://www.fema.gov/flood-maps/national-flood-hazard-layer
You can use the information to better understand your level of flood risk and type of ... Letter of Map Amendment Revalidation Statuses
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36 Declaration of Conformity/Compliance
https://www.foodgradepaint.com/declaration-of-conformity-compliance-food-contact-materials-and-coatings-eu-10-2011-and-fda-21-cfr-175.300_post_62_0_0_0.html
For example, a relevant amendment for the field of coatings was Regulation EU 2018/213 ... EC Regulation 2023/2006 and/or FDA 21 CFR 174.5 .
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37 Form FDA 483 - Wikipedia
https://en.wikipedia.org/wiki/Form_FDA_483
1 Form FDA 483 content. 1.1 Header information; 1.2 Observations. 1.2.1 Annotation. 1.3 Signatures; 1.4 Reverse side; 1.5 Addenda/amendments · 2 Public access to ...
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38 Emergency Response Information Requirements | Help Center
https://www.thecompliancecenter.com/emergency-response-information-requirements/
In addition, emergency response information must also be provided to the carrier Per 49 CFR 172.602. This information can be provided several ...
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39 8 USC 1101: Definitions
https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title8-section1101&num=0&edition=prelim
Jump To: Source CreditFuture AmendmentsMiscellaneousReferences In ... radio, film, or other foreign information media coming to engage in such vocation) ...
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40 Administrative Law: Updating & Tracking Federal Regs
https://libguides.law.drake.edu/c.php?g=150997&p=992519
section that has been impacted by changes published in the Federal Register since the C.F.R. volume's last revision date. It is a cumulative ...
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41 21 CFR Part 312 Investigational New Drug Application
https://www.gmp-compliance.org/guidelines/gmp-guideline/id-21-cfr-part-312-investigational-new-drug-application
› gmp-guideline › id-...
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42 Tracking regulatory changes in the Biden era
https://www.brookings.edu/interactives/tracking-regulatory-changes-in-the-biden-era/
The Brookings Center on Regulation and Markets Regulatory Tracker (“Reg Tracker”) provides background information and status updates on a ...
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43 21 CFR 803 Medical Device Reporting | Greenlight Guru
https://www.greenlight.guru/glossary/21-cfr-803-medical-device-reporting
Medical device user facilities must generate reports with the information outlined in 21 CFR 803.32, which generally correspond with the fields of Form FDA ...
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44 CFR - Code of Federal Regulations Title 21 (2022) - Wahlm
https://wahlm.com/article/cfr-code-of-federal-regulations-title-21-2
FDA Home Medical Devices Databases - The information on this page is current as of Jul 20, 2022. For the most up-to-date version of CFR ...
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45 CRS Reports
https://crsreports.congress.gov/
It operates solely at the behest of and under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other than public ...
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46 2018 CFR e-Book Title 17 Commodity and Securities Exchanges ...
https://books.google.com/books?id=23txDwAAQBAJ&pg=PA479&lpg=PA479&dq=cfr+information+amendment&source=bl&ots=M1FM2VszSz&sig=ACfU3U3Hn7ZK6TBqm9XQKLzsQDtTzIti_A&hl=en&sa=X&ved=2ahUKEwj-6Y6Amcv7AhXdl4kEHWaYCtcQ6AF6BQjHARAD
A registered municipal advisor shall promptly amend the information contained in its Form MA (17 CFR 249.1300): (1) At least annually, within 90 days of the ...
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47 2018 CFR Annual Print Title 10, Energy, Parts 1-50
https://books.google.com/books?id=Ut9wDwAAQBAJ&pg=PA249&lpg=PA249&dq=cfr+information+amendment&source=bl&ots=viDaInImFn&sig=ACfU3U3xTz7rg7353Ld9l8-ukJ6EZxgQBQ&hl=en&sa=X&ved=2ahUKEwj-6Y6Amcv7AhXdl4kEHWaYCtcQ6AF6BQjKARAD
For all other agency records, the Freedom of Information Act and Privacy Act Officer shall correct or amend the record. The Freedom of Information Act and ...
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48 2018 CFR e-Book Title 10, Energy, Parts 51-199: ...
https://books.google.com/books?id=cSBxDwAAQBAJ&pg=PA122&lpg=PA122&dq=cfr+information+amendment&source=bl&ots=eKGFpnxnPT&sig=ACfU3U2uRdtAal1CYd9-D63mLLug02PFNg&hl=en&sa=X&ved=2ahUKEwj-6Y6Amcv7AhXdl4kEHWaYCtcQ6AF6BQjPARAD
If an applicant or licensee proposes to depart from the information required ... amendment, or renewal of a license or for operation under 10 CFR 52.103(a) ...
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49 2018 CFR Annual Print Title 11, Federal Elections
https://books.google.com/books?id=XN9wDwAAQBAJ&pg=PA386&lpg=PA386&dq=cfr+information+amendment&source=bl&ots=DmU6udsl-K&sig=ACfU3U1u2c9Vy55k9tXis9evhePHngpKwg&hl=en&sa=X&ved=2ahUKEwj-6Y6Amcv7AhXdl4kEHWaYCtcQ6AF6BQjRARAD
§9410.5 Disclosure of requested information to individuals. (a) Upon submission of proof of ... 9410.6 Request for correction or amendment to record.
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50 New York Court of Appeals. Records and Briefs.: 84 NY2D 252, ...
https://books.google.com/books?id=pgw7d87w3wAC&pg=PA157&lpg=PA157&dq=cfr+information+amendment&source=bl&ots=6nKw2CFTwu&sig=ACfU3U22ETz5NvxwgcqXyby5XPuo-ckhBg&hl=en&sa=X&ved=2ahUKEwj-6Y6Amcv7AhXdl4kEHWaYCtcQ6AF6BQjSARAD
MAR 90 1992 → Dear Acting Commissioner Kaladjian : This letter constitutes a formal request for additional information on Plan Amendment 91-82 pursuant to ...
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51 The Code of Federal Regulations of the United States of ...
https://books.google.com/books?id=jxE5AAAAIAAJ&pg=PA2893&lpg=PA2893&dq=cfr+information+amendment&source=bl&ots=BXjytuzE8A&sig=ACfU3U0VwgYhBkAdfY6CArsIoBMpyvoO1g&hl=en&sa=X&ved=2ahUKEwj-6Y6Amcv7AhXdl4kEHWaYCtcQ6AF6BQjOARAD
( 9 ) Application for amendment of license ( 18 CFR , 131.30 ) . ... Information concerning any function , form , or procedure of the Commission under Part ...
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52 Little Company of Mary Hospital and Health Care Centers V. ...
https://books.google.com/books?id=uuSxaAX8lSQC&pg=PA2&lpg=PA2&dq=cfr+information+amendment&source=bl&ots=3YKOFA0qNv&sig=ACfU3U2DA3QEIYcm8wZugsrkHt84q9pcew&hl=en&sa=X&ved=2ahUKEwj-6Y6Amcv7AhXdl4kEHWaYCtcQ6AF6BQjIARAD
The amended regulation also provides that a unit must furnish a level a a of care ... The previous regulation was cited as 42 C.F.R. § 405.452 ( d ) and the ...
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