Sunday - September 20, 2020
Federal Tipoffs Involving New Hampshire Newsletter for Sunday March 08, 2020 ( 6 items )  

EPA Extends Comment Period on Draft Clean Water Act Permit for Great Bay
PORTSMOUTH, New Hampshire, March 6 -- The Environmental Protection Agency issued the following news release: The U.S. Environmental Protection Agency (EPA) has extended the public comment period on the draft Clean Water Act permit for New Hampshire's Great Bay by 30 days to allow for additional input from stakeholders. The new deadline for members of the public to submit comments to EPA is April 8, 2020. If finalized as proposed, EPA believes this draft permit could result in significant decrea  more

FDA Issues Notice on Guidance for Industry on Specific Products
SPRINGFIELD, Virginia, March 4 -- The Health and Human Services' Food and Drug Administration has issued a notice, published in the Federal Register on March 3, entitled: "Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability". The notice was issued by Lowell J. Schiller, Principal Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Mara Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bl  more

FDA Issues Notice on Guidance Pertaining to Bone Anchors
SPRINGFIELD, Virginia, March 4 -- The Health and Human Services' Food and Drug Administration has issued a notice, published in the Federal Register on March 3, entitled: "Bone Anchors-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability". The notice was issued by Lowell J. Schiller, Principal Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Laurence Coyne, Center for Devices and Radiological Health, Food and  more

FDA Issues Notice on Guidance Pertaining to Contact Lenses-Performance Criteria
SPRINGFIELD, Virginia, March 4 -- The Health and Human Services' Food and Drug Administration has issued a notice, published in the Federal Register on March 4, entitled: "Soft (Hydrophilic) Daily Wear Contact Lenses-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability". The notice was issued by Lowell J. Schiller, Principal Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Jason Ryans,  more

FDA Issues Notice on Guidance Pertaining to Exocrine Pancreatic Insufficiency Drug Products
SPRINGFIELD, Virginia, March 5 -- The Food and Drug Administration has issued a notice, published in the Federal Register on March 5, entitled: "Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications; Withdrawal of Guidance". The notice was issued by Lowell J. Schiller, Principal Associate Commissioner for Policy. DATES: The withdrawal is effective March 23, 2020. FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Center for Drug Evaluation an  more

FDA Issues Notice on Guidance Pertaining to Purple Book Enhancement
SPRINGFIELD, Virginia, March 5 -- The Food and Drug Administration has issued a notice, published in the Federal Register on March 5, entitled: "Purple Book Enhancement; Establishment of a Public Docket; Request for Comments". The notice was issued by Lowell J. Schiller, Principal Associate Commissioner for Policy. DATES: Submit either electronic or written comments by May 4, 2020. FDA is establishing a docket for public comment. The docket number is FDA-2020-N-0437. The docket will close on M  more