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💼NIH Closed Meeting on Drug Research Contract Proposals Notification

📦Postal Service Announces Priority Mail and Ground Advantage Changes

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 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).

🧬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(FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical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).

📦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.

⚡Notice of Intent for Environmental Assessment - Shenandoah Hydroelectric Project

🩺NIH Meeting Notice

📦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.

⚖️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.

♻️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.