Department of Health and Human Services November 14, 2012 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration User Fee System
In accordance with the requirements of the Privacy Act of 1974 and the Food and Drug Administration's (FDA) regulations for the protection of privacy, FDA is publishing notice of a Privacy Act system of records entitled, ``FDA User Fee System, HHS/FDA,'' System Number 09-10-0021. FDA utilizes the User Fee System (UFS) to collect fees pursuant to Federal law and FDA's implementing regulations. The records kept in this system relate to fees assessed under the Freedom of Information Act (FOIA), the Prescription Drug User Fee Act, the Medical Device User Fee and Modernization Act, the Animal Drug User Fee Act, the Animal Generic Drug User Fee Act, the Mammography Quality Standards Act, the Family Smoking Prevention and Tobacco Control Act, the Food Safety Modernization Act, the Biosimilar User Fee Act, the Generic Drug User Fee Act, and other fees assessed by FDA under its Federal Food, Drug and Cosmetic Act authority such as color additive certification fees and export certificate fees. For purposes of this notice, these fees are collectively referred to as user fees.
Submission for OMB Review; Comment Request: NEXT Generation Health Study; Correction Notice
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 23, 2012 (Volume 77, Number 36) and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment, to correct the omission of the peers survey in the previous notice, and to correct the errant data that appeared in Table 1 and Table 2 of the notice. The data in Table 1 and Table 2 of this notice are correct. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
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