documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

13 rows where docket_id = "FDA-2015-N-0030" sorted by posted_date descending

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posted_year 9

document_type 3

agency_id 1

id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2015-N-0030-53769 FDA None FDA-2015-N-0030 Supplement from Novo Nordisk, Inc. Other Supplement (SUP) 2025-04-29T04:00:00Z 2025 4 2025-04-29T04:00:00Z   2025-04-29T19:32:09Z   0 0 0900006486abc35f
FDA-2015-N-0030-8513 FDA None FDA-2015-N-0030 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2023-02-14T05:00:00Z 2023 2 2023-02-14T05:00:00Z   2023-02-14T14:51:29Z 2023-03073 0 0 090000648569352b
FDA-2015-N-0030-8512 FDA None FDA-2015-N-0030 Extension of the Period Before the Food and Drug Administration Intends to Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products Rule Extension of Comment Period 2022-10-21T04:00:00Z 2022 10 2022-10-21T04:00:00Z   2022-10-21T12:22:13Z 2022-22876 0 0 0900006485442443
FDA-2015-N-0030-8511 FDA None FDA-2015-N-0030 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2022-10-07T04:00:00Z 2022 10 2022-10-07T04:00:00Z   2022-10-07T17:13:32Z 2022-21841 0 0 09000064853d45d8
FDA-2015-N-0030-8509 FDA None FDA-2015-N-0030 Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Notice 60 Day Proposed Information Collection 2022-06-17T04:00:00Z 2022 6 2022-06-17T04:00:00Z 2022-08-17T03:59:59Z 2022-09-19T19:18:53Z 2022-13068 0 0 0900006485178b8f
FDA-2015-N-0030-8507 FDA None FDA-2015-N-0030 Memorandum of Meeting from FDA/CDER Other Memorandum 2021-12-01T05:00:00Z 2021 12 2021-12-01T05:00:00Z   2021-12-01T21:02:19Z   0 0 0900006484e8cda7
FDA-2015-N-0030-8506 FDA None FDA-2015-N-0030 Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out of State Distribution of Compounded Human Drug Products Notice Extension of Compliance Date 2021-08-09T04:00:00Z 2021 8 2021-08-09T04:00:00Z   2021-08-09T13:10:59Z 2021-16937 0 0 0900006484c365db
FDA-2015-N-0030-8455 FDA None FDA-2015-N-0030 Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration; Availability Notice Withdrawal 2020-10-27T04:00:00Z 2020 10 2020-10-27T04:00:00Z   2020-10-27T13:41:21Z 2020-23687 0 0 090000648493647e
FDA-2015-N-0030-8454 FDA None FDA-2015-N-0030 Final Standard MOU Addressing Certain Distributions of Compounded Human Drug Products - For Implementation Other Additional Information 2020-10-26T04:00:00Z 2020 10 2020-10-26T04:00:00Z   2020-10-26T12:19:15Z   0 0 090000648492e60e
FDA-2015-N-0030-0327 FDA None FDA-2015-N-0030 Letter from Avella to FDA DDM Other Letter(s) 2018-08-15T04:00:00Z 2018 8 2018-08-15T04:00:00Z   2018-08-15T18:40:04Z   0 0 0900006483626771
FDA-2015-N-0030-0316 FDA None FDA-2015-N-0030 Testimony from International Academy of Compounding Pharmacists (IACP) Other Testimony 2017-06-09T04:00:00Z 2017 6 2017-06-09T04:00:00Z   2017-06-09T15:38:19Z   0 0 09000064826aef0f
FDA-2015-N-0030-0060 FDA None FDA-2015-N-0030 Testimony from National Home Infusion Association Other Testimony 2016-06-23T04:00:00Z 2016 6 2016-06-23T04:00:00Z   2016-06-23T19:59:14Z   0 0 0900006482046fd4
FDA-2015-N-0030-0001 FDA None FDA-2015-N-0030 Compounding of Human Drug Products Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket Notice Requests for Information (RFI) 2015-03-09T05:00:00Z 2015 3 2015-03-09T05:00:00Z   2026-02-20T20:29:40Z 2015-05376 1 0 0900006481a33cbd

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;