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📊FDA Guidance on Analytical Testing Methods for Tobacco Products

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The guidance provides information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients, and additives, as well as stability testing of tobacco products. This guidance is intended to help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products. This guidance finalizes the draft guidance of the same title issued in December 2021.

♻️EPA's Final Rule on Perchloroethylene Emission Standards for Dry Cleaners

This action finalizes the Clean Air Act (CAA) technology review (TR) conducted for the commercial and industrial dry cleaning facilities using perchloroethylene (PCE) as the cleaning solvent (PCE Dry Cleaning) source categories regulated under National Emission Standards for Hazardous air Pollutants (NESHAP). This final rule does not finalize the changes made at proposal and makes no amendments to the current NESHAP given the recently finalized action under the Toxic Substance Control Act (TSCA) which has instituted a 10-year phaseout of the use of PCE for dry cleaning.

⚖️FDA Guidance on Sex Differences in Clinical Evaluations Available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Study of Sex Differences in the Clinical Evaluation of Medical Products." Clinical trials and non-interventional studies of medical products should be designed to enroll sufficient numbers of females and males to reflect the prevalence of the disease or condition for which the medical product is being investigated to help ensure the generalizability of results and facilitate exploration of potential differences in effects by sex. This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. When finalized, this guidance will replace the guidance entitled "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" issued in July 1993.

📦USPS Notice on New Priority Mail Express Service Agreement

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

🩺NIH Meeting Notice

⚡Notice of Intent for Environmental Assessment - Shenandoah Hydroelectric Project

📦USPS Announces New Priority Mail and Ground Advantage Agreement

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

🧬FDA Guidance on Tissue Biopsies in Clinical Trials for Businesses

The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).

⚖️FDA Guidance on Evaluating Food Allergen Public Health Importance

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

🚢Coastwise Endorsement Eligibility Determination for Foreign Vessels

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.