The applicant shall specify in the notice sent under paragraph (a) of this section the full name of the drug subject to review, the name and contact information of: (1) The individual or organization that was notified pursuant to paragraph (a) of this section in December 2007, and; (2) All the persons and entities to whom the applicant has disclosed the information required by paragraph (a) of this section within the previous 18 months. (d) Form. The notice required by paragraph (a) of this section includes as an attachment the following: (1) A notice of nondisclosure, and; (2) A statement from the applicant's counsel that, pursuant to 21 U.S.C. secs. 360b(a)(4) and 351(a)(42), if the notice was properly provided to the public health officer responsible for drug approval, the applicant has provided the drug subject to review under that authority the opportunity for review of the applicant's abbreviated new drug application in accordance with paragraph (c) of this section and to determine whether the application complies with the requirements of this section. (e) Electronic transmission. The applicant shall electronically transmit the notice to FDA by the date specified in the applicable subsection of this part. (f) Effective date. The notice sent to FDA shall indicate that it is effective 180 days after FDA's receipt of the notice or as otherwise specified by the Secretary. (g) Notice. The abbreviated new drug application may not contain the abbreviated new drug claims in the following forms or as otherwise specified by the Secretary: (1) The claims may not directly or indirectly refer to the abbreviated new drug if the abbreviated new drug application has been amended pursuant to paragraph (b) of this section. (2) The claims may not describe any of the conditions that form the basis for approval, but any claims of the product's intended uses, adverse effects, or other relevant information may be provided if the products uses or intended uses have been disclosed in the relevant clinical trials. These disclosures should be provided on the form approved for submission pursuant to the provisions of section 505 of the Federal Food, Drug, and Cosmetic Act. (h) Compliance. After FDA's determination that the abbreviated new drug application is complete or contains the statements required by this section, the abbreviated new drug application must be submitted to FDA without further review.
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314.96 which the applicant is seeking approval. (b) Sending the notice. The applicant shall send the notice required by paragraph (a) of this section when it receives from FDA an acknowledgment letter
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What is 21 cfr ch i?
21 CFR Part 1 is a section of the Code of Federal Regulations that pertains to the general enforcement regulations for food and drugs in the United States.
Who is required to file 21 cfr ch i?
Manufacturers, importers, distributors, and other parties involved in the production and distribution of food and drugs are required to comply with and file reports under 21 CFR Part 1.
How to fill out 21 cfr ch i?
The specific requirements for filling out 21 CFR Part 1 vary depending on the type of report or filing required. It is recommended to refer to the relevant regulations and guidance documents provided by the FDA for detailed instructions.
What is the purpose of 21 cfr ch i?
The purpose of 21 CFR Part 1 is to establish the general enforcement regulations and requirements for ensuring the safety, purity, and effectiveness of food and drug products in the United States.
What information must be reported on 21 cfr ch i?
The specific information required to be reported on 21 CFR Part 1 depend on the type of report or filing. It may include information about the product, its ingredients, manufacturing processes, labeling, packaging, and distribution.
When is the deadline to file 21 cfr ch i in 2023?
The specific deadline to file 21 CFR Part 1 in 2023 may vary depending on the type of report or filing. It is recommended to refer to the relevant regulations or contact the FDA for specific deadlines.
What is the penalty for the late filing of 21 cfr ch i?
The penalties for late filing of 21 CFR Part 1 can vary depending on the nature of the violation and may include monetary fines, product recalls, suspension of operations, or other enforcement actions by the FDA. It is recommended to consult the specific regulations and guidance documents for detailed information on penalties.
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