Information Collection

Submission of Controlled Correspondence

IC 262988 under ICR 202310-0910-004 · OMB 0910-0727.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0727 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0727 Competitive Generic Therapies Final guidance OCT 2022.pdf	Other-Agency Guidance
0727 Competitive Generic Therapies Final guidance OCT 2022.pdf	Other-Agency Guidance
0727 Cover Letter Attachments for Controlled Correspondence and ANDA Submissions JUNE 2023.pdf	Other-Agency Guidance
0727 Cover Letter Attachments for Controlled Correspondence and ANDA Submissions JUNE 2023.pdf	Other-Agency Guidance
0727 - CPAs draft guidance SEPT 2022.pdf	Other-Agency Guidance
0727 - CPAs draft guidance SEPT 2022.pdf	Other-Agency Guidance
0727 Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA - OCT 2022.pdf	Other-Agency Guidance
0727 Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA - OCT 2022.pdf	Other-Agency Guidance
0727 Controlled Correspondence draft DEC 2022.pdf	Other-Agency Guidance
0727 Controlled Correspondence draft DEC 2022.pdf	Other-Agency Guidance
0727 Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.pdf	Other-Agency Guidance
0727 Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.pdf	Other-Agency Guidance

IC Title:

Submission of Controlled Correspondence

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 10.115; Good guidance practice 21 CFR 314.445; Guidance documents

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	0727 Competitive Generic Therapies Final guidance OCT 2022.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0727 Cover Letter Attachments for Controlled Correspondence and ANDA Submissions JUNE 2023.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0727 - CPAs draft guidance SEPT 2022.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0727 Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA - OCT 2022.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0727 Controlled Correspondence draft DEC 2022.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0727 Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 500

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	5,000	5,000
Annual IC Time Burden (Hours)	25,000	25,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.