Submission of Controlled Correspondence

Generic Drug User Fee Program

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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0727 - CPAs draft guidance SEPT 2022.pdf Other-Agency Guidance
0727 - CPAs draft guidance SEPT 2022.pdf Other-Agency Guidance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

Information Collection (IC) Details

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:

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Other-Agency Guidance	0727 - CPAs draft guidance SEPT 2022.pdf	Yes	Yes	Fillable Fileable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 %

	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

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.