Administrative practices and procedures; internal review of agency decisions---FDA. Direct final rule

The Food and Drug Administration (FDA) is amending its regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. This action is being taken to clarify the availability of review of scientific controversies by such advisory panels and committees. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule. If any significant adverse comment is received, FDA will withdraw the direct final rule and will follow its usual procedures for notice-and-comment rulemaking based on the companion proposed rule.     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The agency is taking this action to clarify the availability of review of scientific controversies by such advisory panels or committees. This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. If FDA receives any significant adverse comment, the direct final rule will be withdrawn, and the comments will be considered in the development of a final rule using usual notice and comment rulemaking based on this proposed rule.     

Advisory committee; Pediatric Advisory Committee; establishment. Final Rule

The Food and Drug Administration (FDA) is announcing the establishment of a Pediatric Advisory Committee in the Office of the Commissioner. Elsewhere in this issue of the Federal Register, FDA is publishing a document requesting nominations for the membership on this committee. This document adds the Pediatric Advisory Committee to the agency's list of standing advisory committees in 21 CFR 14.100.     

Advisory committees; OTC Drugs Advisory Committee; establishment--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the establishment by the Commissioner of Food and Drugs of the OTC Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. Elsewhere in this issue of the Federal Register, FDA is publishing a notice requesting nominations for membership on this committee. This document adds to the agency's list of standing advisory committees.     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.     

Delegations of authority to the Commissioner of Food and Drugs--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to redelegate the authority of the Assistant Director for Health to make determinations to close advisory committee meetings to the public to the Commissioner of Food and Drugs (the Commissioner) and other agency heads. FDA is further redelegating this authority from the Commissioner to the Deputy Commissioner for Operations.     

The politics of abortion in the House of Representatives in 1976

The discussion in the U. S. Congress preceeding the passage of the 1976 Hyde Amendment, prohibiting the use of Medicaid funds for abortions, was described and the results of a multivariate analysis of the factors influencing the votes on the amendment in the House of Representatives were presented. Between June 24-August 10, 1976 there were 3 roll call votes on the amendment in the House of Representatives and during this period support for the amendment increased from 54%-69%. Multiple classification analysis was used to analyze the relative influence of 11 independent variables on the voting behavior of the representatives. The 11 variables included 1) the age, educational level, sex, and religious affliation of the representative; 2) the representative's party affliation, degree of constituent support, and previous voting record on liberal issues; and 3) the average income, racial composition, geographical location, and the % of urban residents in the representative's district. The factor which served as the best indicator of the representative's vote on the amendment was the representative's previous voting record on liberal issues. Those with more liberal voting records tended to vote against the amendment and those with more conservative voting records tended to vote for the amendment. The 2nd best predictor of amendment votes was the religious affliation of the representative. Catholic representatives, compared to Protestant and Jewish representatives, were more likely to support the amendment. Geographical location of the representative's district was a moderate indicator of the representative's vote on the amendment. Representatives from the south were more likely to support the amendment. The degree of constituent support for the representative in his own district was also a moderate indicator of the representatives vote on the amendment. The 11 factors together accounted for 1/3 of the votes.     

Work activity of persons working as members of advisory committees established under the Federal Advisory Committee Act (FACA). Final rule

We are revising our disability regulations under titles II and XVI of the Social Security Act to establish a new, special rule that affects individuals who are receiving payments or providing services as members or consultants of a committee, board, commission, council or similar group established under the Federal Advisory Committee Act (FACA). Under this special rule, we will not count any earnings an individual is receiving from serving as a member or consultant of a FACA advisory committee when we determine if the individual is engaging in substantial gainful activity under titles II and XVI of the Social Security Act (the Act). In addition, we will not evaluate any of the services the individual is providing as a member or consultant of the FACA advisory committee when determining if the individual has engaged in substantial gainful activity under titles II and XVI of the Act. Based on our experience with FACA advisory committees and the frequency and level of activity required by these committees, we believe that performance of activity on these committees does not demonstrate the ability to perform substantial gainful activity. We believe this to be consistent with Congress's view, as it has recognized in creating the Ticket to Work advisory committee, for example, that current disability beneficiaries should be considered for membership. This also will encourage individuals with disabilities to serve on FACA advisory committees, thereby providing the benefit of their unique perspective on policies and programs to the Federal Government.     

Revisions to the requirements applicable to blood, blood components, and source plasma; confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule issued in the Federal Register of August 19, 1999. The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is amending Title 21 Code of Federal Regulations to reinstate the former provisions.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule that appeared in the Federal Register of May 14, 1999 (64 FR 26282). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is hereby amending Title 21 Code of Federal Regulations to reinstate the former provisions. In addition, FDA is correcting the precision of the value for protein concentration that was inadvertently omitted from the codified section of the direct final rule.     

Status of certain additional over-the-counter drug category II and III active ingredients--FDA. Final rule

The Food and Drug administration (FDA) is issuing a final rule stating that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA is issuing this final rule after considering the reports and recommendations of various OTC drug advisory review panels and public comments on proposed agency regulations, which were issued in the form of a tentative final monograph (proposed rule). Based on the absence of substantive comments in opposition to the agency's proposed nonmonograph status for these ingredients, as well as the failure of interested parties to submit new data or information to FDA under the regulation, the agency has determined that the presence of these ingredients in an OTC drug product would result in that drug product not being generally recognized as safe and effective or would result in misbranding. This final rule is part of the ongoing review of OTC drug products conducted by FDA.     

Knowledge,Expertise, and Committee Power in the Contemporary Congress

Scholars, practitioners, and observers typically portray committee influence as rooted in traditional congressional processes and practices, which are thought to provide committees with powerful opportunities to block and shape legislative proposals. The erosion of regular order processes suggests these traditional processes cannot underlie committee power in the contemporary Congress. Drawing on a mixed‐methods approach of interviews with congressional staff and an original data set of every amendment offered on the floor of the House of Representatives from 2005 to 2008, I find that absent these traditional process norms, committees in the contemporary Congress can rely on their specialized knowledge and expertise to influence the behavior of their colleagues and shape the legislation that passes.     

Rights by Fortune or Fight? Reexamining the Addition of Sex to Title VII of the Civil Rights Act

It is widely believed that the extension of protection against employment discrimination to women through Title VII of the Civil Rights Act (CRA) was a fluke, the product of an attempted “killer amendment” by civil rights opponents gone awry. My analysis challenges this conventional wisdom, showing that the coalition of Republicans and southern Democrats in support of the sex amendment to Title VII was consistent with broader patterns of support for the Equal Rights Amendment (ERA) in the early to mid‐20th century. In other words, support appears to have been sincere, not sophisticated—proponents preferred a CRA with the sex amendment to one without. I proceed to show that concern about the direct impact on women, and not simply the instrumental impact on labor, played an important role in motivating this support. But, I also find reason for caution in interpreting support for workplace rights as evidence of broad support for women's rights at this time.     

Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule

The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing advisory committees.     

Advisory committees; establishment and termination--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the establishment by the Commissioner of Food and Drugs of the Medical Devices Advisory Committee and the termination of the existing devices panels. This document revises the agency's list of standing advisory committees to show these actions.     

Employment discrimination: procedures for handling complaints--Equal Employment Opportunity Commission. Proposed rule

This proposed rule sets forth procedures for the handling of complaints of employment discrimination which are filed with Federal fund granting agencies under Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972 and other provisions of Federal law which prohibit discrimination on grounds of race, color, religion, age, sex or national origin in programs or activities receiving Federal financial assistance. The regulations allow the fund granting agency to refer complaints to the Equal Employment Opportunity Commission (EEOC). For complaints covered both by Title VII of the Civil Rights Act of 1964, as amended, or other statutes within EEOC's jurisdiction and by Title VI of the Civil Rights Act or Title IX, the regulations contemplate that most complaints of individual acts of discrimination will be referred to EEOC for investigation and conciliation, while most complaints of systemic discrimination will be retained by the fund granting agency. Employment discrimination complaints which are not covered by Title VI or Title IX will be transferred to EEOC. This proposed rule is not a "major rule" as defined by Section 1(b) of Executive Order 12291.     

Advisory committee; Medical Imaging Drugs Advisory Committee; re-establishment

The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.     

First amendment protection for online platforms

The United States is home to some of the largest online platforms in the world, in part due to Section 230 of the Communications Decency Act of 1996. Section 230 provides platforms with extraordinarily broad immunity from lawsuits arising from user content. The statute is under unprecedented scrutiny, and Congress already has amended the statute to weaken its protections. This Article examines the First Amendment protections that would remain for online platforms if Congress were to entirely eliminate Section 230. After reviewing pre-Internet cases involving offline distributors such as bookstores and newsstands, this Article concludes that although the First Amendment would offer some protections to platforms, these protections would be limited and likely would require platforms to significantly alter their operations and business models.     

First Amendment Protection for Online Platforms

The United States is home to some of the largest online platforms in the world, in part due to Section 230 of the Communications Decency Act of 1996. Section 230 provides platforms with extraordinarily broad immunity from lawsuits arising from user content. The statute is under unprecedented scrutiny, and Congress already has amended the statute to weaken its protections. This Article examines the First Amendment protections that would remain for online platforms if Congress were to entirely eliminate Section 230. After reviewing pre-Internet cases involving offline distributors such as bookstores and newsstands, this Article concludes that although the First Amendment would offer some protections to platforms, these protections would be limited and likely would require platforms to significantly alter their operations and business models.