Robert Latta

Mr. LATTA

Mr. LATTA. Madam Speaker, it is my great pleasure to pay special tribute to an outstanding student from Ohio's Fifth Congressional District. I am pleased to announce that John Hamernik of Maumee, Ohio has been offered an appointment to the United States Military Academy in West Point, New York. John's offer of appointment permits him to attend the United States Military Academy this fall with the incoming Class of 2024. Attending one of our nation's military academies not only offers the opportunity to serve our country, but also guarantees a world-class education while undertaking one of the most challenging and rewarding experiences of their lives. John brings a tremendous amount of leadership, service, and dedication to the incoming Class of 2024. While attending Anthony Wayne High School in Whitehouse, Ohio, John was a member of the National Honor Society, Student Council President, member of the Rotary Interact Club, and a Buckeye Boys State attendee, while maintaining a 4.25 GPA. Throughout high school, John was involved with baseball and rowing among other extracurricular activities. I am confident that John will carry the lessons of his student and athletic leadership to the Military Academy. Madam Speaker, I ask my colleagues to join me in congratulating John Hamernik on his offer of appointment to the United States Military Academy. Our service academies offer the finest military training and education available. I am positive that John will excel during his career at West Point, and I ask my colleagues to join me in extending their best wishes to him as he begins his service to our nation.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I thank my friend for yielding. Mr. Speaker, I rise in opposition to H. Res. 965, which is a flagrant disregard to the Constitution and House traditions. Proxy voting has previously been deliberated in this body. In 1970, an amendment was offered to ban all forms of proxy voting in committees. It argued committee members should be present in person to listen to debate, discuss, and vote. Proxy voting tends to add to the cloud of suspicion hanging over Congress. The use of proxy voting on important bills gives up a Member's voice and adds to the appearance of secrecy. In 1974, an amendment was offered to entirely ban proxy voting. It was adopted by this House but later overturned by the Democratic Caucus. A CRS report gave the opponents' views to proxy voting by stating that it contributes to the domination of committee chairs, contributes to absenteeism, and detracts from the care necessary to formulate sound legislation. A history maxim states that he who forgets the past is condemned to repeat it. Learn from our past and vote ``no.''

Mr. LATTA

Mr. LATTA. Mr. Speaker, I include in the Record this Statement of Intent on Data Required for General Recognition of Safety and Effectiveness. The OTC drug monograph reform legislation requires that nonprescription drugs be shown to be generally recognized as safe and effective. This standard of general recognition is based on statutory language that has been in the Federal Food, Drug, and Cosmetic Act since its enactment in 1938, and it was incorporated in the regulations issued by the Food and Drug Administration when the OTC Drug Review was established in 1972. In particular, 21 CFR 330.10(a)(4)(i) states that: . . . Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use. This proof shall include results of significant human experience during marketing. General recognition of safety shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data. Similarly, 21 CFR 330.10(a)(4)(ii) states that: . . . Proof of effectiveness shall consist of controlled clinical investigations as defined in Sec. 314.126(b) of this chapter, unless this requirement has been waived on the basis of a showing that it is not reasonably applicable to the drug or essential to the validity of the investigation and that an alternative method of investigation is adequate to substantiate effectiveness. Investigations may be corroborated by partially controlled or uncontrolled studies, documented clinical trials by qualified experts, and reports of significant human experience during marketing. Isolated case reports, random experience, and reports lacking the details which permit scientific investigation will not be considered. General recognition shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data. These regulations clearly recognize the importance of what is now termed ``real world evidence,'' including experience from marketing, in determining general recognition of safety and effectiveness. In addition, they recognize that results of clinical studies supporting general recognition of safety and effectiveness will in most instances be contained in the published scientific literature. Such publications seldom, if ever, contain the same level of detail as the clinical study reports and data tabulations submitted in support of new drug applications, but it has long been understood that they may form the basis for determinations of general recognition of safety and effectiveness under the OTC monograph system. Finally, the regulations clearly permit determinations of general recognition of safety and effectiveness to be based on sources of information other than the published scientific literature, including, for example, unpublished data from studies carried out by federal government agencies or other competent bodies which are made available to the FDA in the process of administering the OTC monograph system. It is our intent that the FDA should continue to apply these standards in making determinations of general recognition of safety and effectiveness under the monograph reform legislation. Statement of Intent as to Minor Changes Provision Under current law, dosage forms for monograph OTC drugs have largely been limited to the technology in use in 1972, when the OTC Drug Review began. The only mechanism for introducing truly innovative dosage forms has been through the new drug application (NDA) process, which entails disproportionate costs and delays. This has proved to be a significant hurdle to use of new technologies that could offer consumers greater convenience and choice in OTC drug products. The legislation creates two new procedures for introducing innovative dosage forms for monograph OTC drugs that would not otherwise be permitted under subsection (b). First, sponsors may initiate proceedings for the issuance of administrative orders under subsection (c) to provide for use of novel dosage forms. Second, in appropriate cases, sponsors may make minor changes in dosage forms without prior approval from FDA, using the procedure in subsection (d). The sponsor must maintain information necessary to demonstrate that the change will not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the drug in comparison to a suitable reference product. The sponsor must also submit updated drug listing information to FDA within 30 days of introducing the new product to the market. FDA will have the right to demand access to the relevant files, and there will be a quick and simple procedure to resolve any disagreement between FDA and the sponsor as to the adequacy of the data supporting the change. Before the subsection (d) procedure takes effect, FDA must issue administrative orders setting out the type of information required to support minor changes in dosage forms. In issuing those orders, FDA will take account of standard procedures and practices for evaluating the quality of drug products, including applicable provisions of the United States Pharmacopeia/National Formulary, as well as special needs of populations, including children. The procedures in subsections (c) and (d) will only be required for changes that would not otherwise be permitted under subsection (b). Thus, changes in excipients or other inactive ingredients and similar aspects of formulation of monograph OTC drug products will be permitted without prior approval provided they are fully consistent with requirements of applicable monographs or administrative orders and with general requirements for monograph OTC drugs, including, among other things, requirements for the use of suitable inactive ingredients which are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays. When such changes are made, sponsors will be required to submit updated drug listing information to FDA within 30 days of introducing a product to the market. USP and International Conference on Harmonization as sources for standards descriptions in minor changes administrative order with guidances by route of administration An important objective of this legislation is to create procedures that will promote innovation by permitting manufacturers to introduce certain new and improved dosage forms for nonprescription monograph drugs without the need for prior FDA approval. Manufacturers will be required to maintain files containing data showing that such changes will not affect the safety or effectiveness of their products and provide those files to FDA on request. The bill directs FDA to issue administrative orders and guidances describing the types of changes that can be made without prior approval and the data that manufacturers should have on file. Subsection (d)(3)(B) requires that, in issuing such orders and guidances, FDA should take account of relevant public standards for evaluating the quality of drug products. Examples of the standards that FDA should take into account include the monographs and other provisions of United States Pharmacopeia/National Formulary and guidelines issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). FDA is a major stakeholder in both organizations, and it is appropriate that any administrative orders it adopts should take account of relevant requirements issued by them. Labeling considerations under minor changes provision This bill establishes procedures under which FDA can issue binding administrative orders setting forth the requirements under which nonprescription drugs will be regarded as generally recognized as safe and effective and may be lawfully marketed without an approved new drug application. It is intended that these orders will be similar in content to the monographs that FDA has issued under the current procedures of the Over-the-Counter (OTC) Drug Review. That is, they will contain provisions concerning active ingredients, dosages and dosage forms, and instructions for safe use of the products to which they apply and, where appropriate, other conditions required to assure safety and effectiveness. Nonprescription drugs marketed under such orders must also comply with general requirements of the Federal Food, Drug, and Cosmetic Act and applicable FDA regulations, including general requirements for labeling and quality. As is true under the current regulatory system, labels and labeling for nonprescription drugs may contain additional information, including brand names, promotional statements, and other information, provided that any such information is truthful and non-misleading.

Mr. LATTA

Mr. LATTA. Madam Speaker, I rise today to celebrate the Bicentennial of Paulding County, Ohio, the last frontier to be settled in our great state. Our country was founded because of the brave pioneers who ventured into the Great Outdoors in order to create a better life for future settlers. In 1819, Captain James Riley and his surveyors trudged through the mosquito infested Great Black Swamp to lay out the township lines for what would later become Paulding County. The Great Black Swamp covered more than 1,500 square miles. It was created more than 10,000 years ago after the glaciers receded and formed the Great Lakes. From the surveyor's notes, we know that the Ottawa and Shawnee Indian tribes inhabited this land of deciduous swamp forest. The giant oaks, hickory, elm, ash, and many other large tree species created a dense canopy, which blocked sunlight from reaching the forest floor. The dense forest and mucky conditions made settlement of the area extremely difficult as Paulding County, in its entirety, laid beneath the swamp. The landscape required drastic alterations before settlers were able to make Paulding County into the flat, agriculturally rich region that it is today. In 1820, this area was named Paulding County in honor of John Paulding, an American hero during the American Revolution who aided in the capture of Major John Andre, a British spy who was the co- conspirator of Benedict Arnold. The celebration of the 200th Anniversary of Paulding County reminds our community of the determination and pioneering attitude upon which counties throughout Ohio and our country were founded. Congratulations to Paulding County on this significant milestone.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I thank the Republican leader of the Energy and Commerce Committee for yielding. I rise in opposition to H. Res. 826. This resolution is solely a political talking point. The administration's proposal does not harm Medicaid. I applaud the Trump administration for moving in the right direction. Block grants give States the flexibility to invest in their citizens' best interests, while spending an estimated $1.4 trillion over the next 10 years. That is trillion. It is plain and simple. Children, seniors, and individuals with disabilities will not be negatively affected by this option, and those in low-income communities will be greatly benefited. Additionally, CHIP and many of the other Medicaid demonstrations are currently running under similar structures. As earlier stated by the Republican leader, States do know what is best for their residents. By giving States the options to voluntarily participate in this program and to share in the Federal savings, it is a win. This resolution is simply a Democrat health scare tactic, and I encourage all of my colleagues to oppose H. Res. 826.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I rise today in support of the right to life for every unborn child. But before I start, I want to thank the gentleman from Jersey for his tireless work and efforts to reverse this decision and to make sure that life is what we are about in this country, because, tragically, in the 47 years since Roe v. Wade, there have been more than 60 million abortions in our country. This is more than a statistic. These are innocent lives lost. Even if this decision is brought back before the Supreme Court, abortions can still be prevalent due to the increasing use of chemical abortion pills. That is why my bill, the SAVE Moms and Babies Act, is necessary, to ensure that the current FDA policy regulating these dangerous pills will stay in place--preventing expanded use--to protect the health and safety of women. I am a committed advocate for pro-life policies, for the protection of the sanctity of life. I appreciate and thank those who offer an unwavering dedication to defending the unborn, despite a culture that often marginalizes pro-life values. Such perseverance is incredibly inspiring. It is an important reminder that we must all be a voice for the voiceless. The fight for life must continue.

Mr. LATTA

Mr. LATTA. Madam Speaker, I yield 1 minute to the gentleman from North Dakota (Mr. Armstrong).

Mr. LATTA. Madam Speaker, I yield myself the balance of my time. It is absolutely important that the United States develop these standards so that we can stay at the top of 5G deployment. As I mentioned in the earlier bill, we want to make sure that 5G is out there to support everyone across the United States. Because of that, we have to make sure that we have these standards in place. Madam Speaker, I urge support of this legislation, and I yield back the balance of my time.

Mr. LATTA. Madam Speaker, I yield 3 minutes to the gentlewoman from Indiana (Mrs. Brooks) and I thank her very much for her work on this legislation.

Mr. LATTA. Madam Speaker, I yield 2 minutes to the gentleman from Michigan (Mr. Walberg), and I thank him also for his hard work on this legislation.

Mr. LATTA. Madam Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Carter).

Mr. LATTA. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H.R. 4500, the Promoting United States Wireless Leadership Act of 2019. Our communications networks are critically important assets for facilitating domestic and international commerce. For decades, the U.S. has led the development of wireless technology with like-minded nations. With the deployment of the next-generation wireless technology, 5G, expected to skyrocket in 2020, we must continue to focus on bolstering foundational elements to make sure the United States continues to lead on future advancements. As these standards are set in global, industry-led standards bodies, we must enhance participation by U.S. companies and remain vigilant that bad actors don't game the system for their own economic and national security interests. To keep accountability and ensure proper transparency, we must encourage participation by trusted parties. The National Telecommunications and Information Administration plays a central role in these efforts as the executive branch agency with technical experience. They have decades of expertise working with industry and other stakeholders to develop these technical standards globally. I would like to thank the dedicated career staff who work tirelessly to advance U.S. global wireless leadership. As we move into the next decade, it is vital that we continue to enhance participation in critical standards-setting bodies and preserve U.S. wireless leadership. I urge my colleagues to support this legislation. Madam Speaker, I reserve the balance of my time.

Mr. LATTA

Mr. LATTA. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H.R. 2881, the Secure 5G and Beyond Act of 2020. In today's digital age, we rely on our communications networks for everything from grocery shopping to applying for jobs. In the past decade, we have upgraded from 2G to 4G and are now in the process of entering the fifth generation of communications networks to accommodate Americans' demand for access. Making a simple transaction online is second nature for many Americans, and we expect the network on which the information is transmitted to be secure. The legislation before us is a step forward in enhancing network security. It requires the President, in consultation with appropriate Federal agencies, to develop a strategy to ensure the security of 5G and future generations of telecommunications systems and infrastructure. The administration must also identify potential security threats or vulnerabilities and promote responsible international development in deployment of networks. Lastly, the bill requires a strategy implementation plan and charges the National Telecommunications and Information Administration to carry it out. It is essential that the administration continues to take steps to secure our networks, and this bill provides direction to do just that. Madam Speaker, I urge my colleagues to support this piece of legislation, and I reserve the balance of my time.

Mr. LATTA. Madam Speaker, I yield 2 minutes to the gentleman from Utah (Mr. Curtis).

Mr. LATTA. Madam Speaker, I yield myself such time as I may consume. Again, I thank my colleague, the gentleman from Pennsylvania (Mr. Michael F. Doyle), the chairman of the subcommittee, for making sure this bill came to the floor today, because we have to win this race for 5G as a Nation, because we have to make sure that it helps every segment of our society. The legislation is going to help us develop a strategy to ensure the security of 5G and future generations of telecommunication systems and infrastructure. And we also must identify potential security threats for vulnerabilities and promote responsible international development and deployment of networks. So I urge my colleagues to support this legislation. Madam Speaker, I yield back the balance of my time.

Mr. LATTA

Mr. LATTA. Madam Speaker, I am prepared to close. Madam Speaker, from the comments that we have heard on the floor today, it is so important that we pass this piece of legislation. It is a good piece of bipartisan legislation, and I urge its support from this House. Madam Speaker, I yield back the balance of my time.

Mr. LATTA. Madam Speaker, I yield 3 minutes to the gentleman from Texas (Mr. Flores), and I applaud him on his hard work on this legislation.

Mr. LATTA. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H. Res. 575, a resolution to encourage all stakeholders involved in the deployment of 5G communications technology to adhere to the Prague Proposals. The Prague Proposals resulted from the Prague 5G Security Conference earlier last year, where representatives from 32 countries met to discuss concerns about equipment supplied by certain vendors that pose a threat to national security. With 5G poised to support an array of critical functions and services over the next decade, it is imperative that we ensure the equipment used to build these networks is secure. By encouraging all stakeholders at home and abroad to abide by these principles, we are sending a strong message that we are taking the security of our networks seriously. Madam Speaker, I urge my colleagues to support this resolution, and I reserve the balance of my time.

Mr. LATTA

Mr. LATTA. Madam Speaker, this is a sad day for our country, one that our forefathers warned us against. We have watched this illegitimate impeachment process unfold while making a mockery of our constitutional duties. House Democrats have conducted the most polarizing impeachment process in our Nation's history, and the men and women I represent are tired of this Democrat- run House putting political games above our Nation's interests. House Democrats held secret meetings, withheld important documents, deliberately misrepresented information to the public, and did not give due process to the President. This investigation was unfair, and the American people expect more out of Congress. The Articles of Impeachment are not based on facts but, instead, are entirely politically motivated. The truth is there was no pressure put on President Zelensky, and the transcripts confirm that there was no conditionality. This inquiry has been rigged from the start, lacking fairness, transparency, and truth. It has been a waste of taxpayers' dollars, and it is based off the opinion of an unnamed whistleblower and hearsay. The accusations in today's proceedings do not align with the facts. This impeachment process is out of step with existing precedent for Presidential impeachment proceedings, and it is not a process I will support. I urge my colleagues to put country first and vote in opposition to the Articles of Impeachment.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 4998, the Secure and Trusted Communications Networks Act. We must protect our critical communications infrastructure from vulnerabilities, and today we are taking further steps to remove suspected equipment from our networks and ensure its overall security going forward. This bill takes into account important concerns we have heard from small, rural providers that were previously unaware of possible security risks when selecting vendors and making purchasing decisions. H.R. 4998 will help fix this information gap by ensuring they have access to the information they need to keep their networks and Americans secure. It should not matter where you are trying to connect, whether you are in rural America or anywhere else. We must ensure the entire communications system is protected from bad actors. Mr. Speaker, I have no other speakers. I urge my colleagues to support H.R. 4998, and I yield back the balance of my time.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I also want to thank the chair for her work on this legislation. I urge support of H.R. 4779 from this House, and I yield back the balance of my time.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 3172, the Safe Sleep for Babies Act. H.R. 3172 addresses the risk of suffocation that infants face related to inclined sleepers. It bans all products with an inclined sleep surface greater than 10 degrees to address tragic deaths related to inclined sleepers. It also addresses the risk of suffocation infants face related to padded crib bumpers. I also want to thank the gentleman from California (Mr. Cardenas) for his work on this bill. I urge my colleagues to support this measure, the Safe Sleep for Babies Act. Mr. Speaker, I yield back the balance of my time.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in strong support of the MAPS Act. Combined with H.R. 4229, the Broadband DATA Act, this bill will bring further accountability to our broadband availability maps. With millions of dollars directed toward broadband subsidies, it is critical that those submitting coverage information to the Federal Communications Commission do not intentionally mislead policymakers with grossly inaccurate data. This bill is intended to deter truly bad actors from overstating their coverage, and it is an important piece to our overall goal to fix our Nation's broadband maps. Mr. Speaker, I urge my colleagues to support the MAPS Act, and I yield back the balance of my time.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 2647, the Safer Occupancy Furniture Flammability Act, or SOFFA. SOFFA adopts a national Federal standard for upholstered furniture. SOFFA is important to ensure uniformity in the regulation of flammability standards for upholstered furniture to avoid a patchwork of State laws. This provides necessary certainty to the industry and also safety for consumers who know, no matter what their ZIP Code is, they will enjoy the same protections. I am glad to see my friends across the aisle agree that the Federal Government must act to establish a national standard here. This debate is timely because we are having this very same discussion with respect to online privacy. As my good friends know, the internet knows no boundaries. Upholstered furniture, like privacy, should enjoy a national standard to avoid a patchwork of State laws. If it makes sense here, it must make sense with privacy. We do not want States regulating the internet differently. Consumer protections should not depend on Zip Codes. I am encouraged to see my colleagues agree today that, with upholstered furniture, a national framework makes sense. I urge them to apply the same to online privacy. Mr. Speaker, I thank the gentlewoman from California (Ms. Matsui) and the gentleman from Virginia (Mr. Griffith) for their bipartisan work on this bill, and the chair, the gentlewoman from Illinois (Ms. Schakowsky), for her work on this legislation. Mr. Speaker, I again urge my colleagues to support SOFFA, H.R. 2647, and pass this very important legislation, and I yield back the balance of my time.

Mr. LATTA

Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in strong support of the Broadband DATA Act. Over the last several Congresses, I have been focused on improving our broadband availability maps, so we not only inject fiscal responsibility into our Federal programs but to also connect thousands of my constituents who lack basic access to a meaningful internet connection. As we approach the end of the second decade in the 21st century, we must ensure all Americans are able to participate in the digital economy. Since passage of the 1996 Telecommunications Act, the private sector has invested roughly $1.7 trillion in their networks using different technologies. This private investment in rural broadband deployment is commendable and needed, but we must also make sure that government- supported solutions complement private investment instead of competing with it. The Broadband DATA Act will do just that. It will improve our Nation's coverage maps so that we can better pinpoint where internet access is and where it isn't. This accuracy is vital in directing Federal funds to communities that need it the most. That is why I am pleased to see this important broadband mapping legislation before us today. I have worked on this bill with my friends across the aisle--specifically my good friend, the gentleman from Iowa (Mr. Loebsack)--and in the Senate. I appreciate the renewed focus this Congress has on improving the broadband maps because it is critically important our future funding decisions are based upon data that is verified, accurate, and granular. As Members of Congress, we know our districts better than anyone, and we hear from those who do not have service. When we compared our knowledge with the existing maps, we recognized the need to take action and fix the maps to reflect reality. While the Broadband DATA Act will move us closer in that direction, it is an evolving landscape and inevitably we will need to continually evaluate their effectiveness. That is why this bill includes a robust, user-friendly challenge process to appropriately dispute potential inaccuracies within the coverage maps. The challenge process is yet another layer to ensuring Federal funds are going to communities that need it most and ultimately bridging the digital divide in Ohio and across the entire Nation. Mr. Speaker, today we are taking a meaningful step to promote broadband deployment in rural America. I urge my colleagues to support this measure, and I reserve the balance of my time.