Becoming American( formerly Life in the United States & the Philippines-1960 to the Present): Have You Heard of Environmental Assessments for New Drugs and Biologics?

WELCOME TO MY SITE AND HAVE A GOOD DAY

Welcome to Las Vegas, Nevada- the Gambling Capital of US and the City that never sleeps! So, what has this city have to do with this site. The answer is none. I just love the photo, I took during our vacation to this city a couple of years ago. In this site, you will find articles from my autobiography, global warming, senior citizens issues, tourism, politics in PI, music appreciation and articles about our current experiences as retirees enjoying the "snow bird" lifestyle between US and the Philippines. Your comments will be highly appreciated. Some of the photos and videos on this site, I do not own. However, I have no intention on infringement of your copyrights. Cheers!

Wednesday, January 18, 2023

Have You Heard of Environmental Assessments for New Drugs and Biologics?

The latest Climate Change Calamities that has ravaged the State of California starting 3 weeks ago reminded me of an article I wrote about Environmental Assessments. Today may be the end of this atmospheric river this year, but I am sure this will happen again in the future. Here's the article for your information.

I believe most of my readers in this blog have not heard of environmental assessments requirement for new drugs and biologics applications submitted to the FDA. At that time, part of my job as a Review Chemist is to evaluate the adequacy of the Environmental Assessment (EA) report submitted by an applicant for new drug application. An EA is a concise public document that evaluates the potential risk for the drug or feed additive to cause significant environmental impacts. Using fate, exposure, and effects data, the EA focuses on relevant environmental issues relating to the use and disposal of drugs or feed additives (21 CFR 25.40).

Here's a summary of the guidance published for the information of the public and the pharmaceutical industry, published July, 1998. I hope you are curious enough that you will read it.

GUIDANCE FOR INDUSTRY Environmental Assessment of Human Drug and Biologics Applications

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses.

The Food and Drug Administration (FDA) is required under NEPA to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process.

FDA's regulations in 21 CFR part 25 specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, investigational new drug applications (INDs) and for various other actions (see 21 CFR 25.20), unless the action qualifies for categorical exclusion.

Under the President's reinventing government (REGO) initiatives, announced in April 1995, FDA reevaluated and revised its environmental regulations to reduce the number of EAs required to be submitted by industry and, consequently, the number of findings of no significant impact(FONSIs) prepared by the Agency under NEPA. FDA issued for public comment a notice of proposed rule making on April 3, 1996 (61 FR 14922) (republished May 1, 1996 (61 FR 19476)),that proposed additional categorical exclusions for those actions that have been identified as normally not having a significant effect, individually or cumulatively, on the quality of the human environment.

The final rule was published on July 29, 1997 (62 FR 40569), and became effective August 28, 1997. All applications or petitions requesting Agency action (e.g., NDAs, abbreviated new drug applications (ANDAs),INDs, biologics license applications (BLAs), supplements to such applications) must be accompanied by either an EA or a claim of categorical exclusion.Failure to provide (1) a claim of categorical exclusion or (2) an adequate EA, is sufficient grounds for refusing to file or approve the application (21 CFR 314.101(d)(4), 601.2(a) and (c), and 25.15(a)). An EA that is adequate for filing is one that addresses the relevant environmental issues.

An EA adequate for approval is one that contains sufficient information to enable the Agency to determine whether the proposed action may affect significantly the quality of the human environment. This guidance provides information on when an EA should be submitted; it also makes recommendations on how to prepare EAs for submission of drug or biologics applications to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

This guidance has been prepared under the direction of the Chemistry Manufacturing Controls Coordinating Committee, Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. This guidance represents the Agency's current thinking on environmental assessments. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

For Details read:

https://www.fda.gov/media/70809/download

Meanwhile enjoy this photo from my collection:

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ABOUT ME

I am a retired (Chemistry Team Leader from USFDA) Filipino-American who loves writing, gardening and photography. My wife ( of 59 years) and I enjoy the snowbird lifestyle between the US and the Philippines. We have a small but very private beach resort in the beautiful island of Marinduque, Philippines. I have several blog sites (ten), a personal blog, blogs about Marinduque and about our beach resort and conference center-CHATEAU DU MER. I have also a writing account for Hubpages.com. I will appreciate very much any comments on my postings.

Genealogy of the Balleza and Katague Surnames

Several years ago, I started a genealogy of my mother's last name- “Balleza”. I was able to trace it back to the 15th century. The name originated from Bilbao, Spain. I then traced it to Mexico, then to US in Texas and then to the Philippines. I was able to locate a town in Mexico named Balleza, in the state of Chihuahua. The town was founded in 1640 and named after Fr. Mariano Balleza ,a Spanish friar.. I was able also to communicate with a radio announcer in Houston, Texas whose family name is also Balleza. I also found several Balleza families in Googles and recently in Face Book. Note that the name is similar to another name in the Philippines “ Belleza”, a Spanish word which means beautiful. But “Balleza” and “Belleza” are two different names in the Philippines. I am happy and satisfied with the origin of my mother's last name. When my mother was still alive, she told me that her grandfather was a Spanish soldier that participated in the Spanish colonization of the Philippines (1565 -1898). Today, I am curious on the genealogy of my father's last name. When my father was still alive, his last named was spelled with a “C” instead of the “K”. He changed it with the “K” when he was in high school. My father has two brothers who also changed it to start with a “ K”. But all of my father other relatives as far as I know has not change it. So there are a lot of “Catague's” in the Philippines, that are my relatives. The famous Catague is a painter named Fernando. His paintings are exhibited in the museum of Iloilo and Manila. My father has informed me that Fernando is a relative and originally was from Antique. . In the Philippines, I know there are Katagues in Iloilo, Negros Occidental, Bohol, Antique, Cavite and in Mindanao. I also found there is a Katague in Brazil from Googles. I just recently meet a niece in Face Book from Vancouver, B.C. She is the daughter of my first cousin from Bacolod, Negros Occidental. There are several Katagues in Face Book, and one in Twitter, but I do not know if we are related. Incidentally, there is a town in Bohol, named “Catague”. I am curious, how the town got its name, but I do not have the time to do research on it. If you know, please let me know. It will be highly appreciated.

There are several variations of the Katague name. These are: Catague, Catage, Catagi, Katagi, Katage, Kataque and Kata Gue ( from Indonesia). I know of a Japanese chemist with surname of Katagi. It may be true that Katague originated from Japan from the surname Katagi as my father once mentioned. So if your last name is any of the above or if you are married to someone with any of the names above, we may be related. I will appreciate if you contact me in Face Book or in this site. I will be delighted to meet you on line or in person.

Genealogy of the Nieva Clan-Macrine's Maternal Side of the Family

It is summer time and time for family reunions. The Nievas of the World will probably be have a reunion in the Philppines or here in US sometime this year or next year. Hopefully, Macrine and I could attend this time.

Macrine Nieva Jambalos and husband, David Balleza Katague of Marinduque and Northern California toasting champagne during their Golden Wedding Anniversary, Boac, Marinduque, Philippines,2007 In 2003, there was a reunion of the Nieva clan in the Philippines organized by Rene Elizalde Nieva, Macrine's first cousin. We were invited but not able to attend. Rene wrote in his invitation that he is in the process of writing a book about the Nieva clan. He said the book will be privately published with limited printing which will include a general history starting on the possible roots of the Nieva family as well as the achievements of various members of the clan and their contribution to the betterment of Marinduque and of the Philippines. As of this writing date, I have not heard on the status of Rene's book. In his invitation he invited all the direct and indirect descendants of the children and spouses of Calixto Nieva and Epifania Morente. Note that Rene is the great-grandson of Calixto Nieva and Macrine is also the great-granddaughter of Calixto Nieva , thus Rene and Macrine are first cousins. I just can not believe that my six grand children are now the great-great-great grand children of Calixto Nieva and Epifania Morente. Calixto and Epifania Morente had six children, four boys and two girls as follows (from oldest to youngest) along with their spouses. 1.Juan Nieva had two wives. The first wife was Isabel Decena. When Isabel died Juan remarried Elvira Sarmiento. Juan Nieva is both Macrine's and Rene's grandfather. He was the first governor of Marinduque and also the grandfather of the outgoing Governor. Rene and Macrine are first cousin of Jose Antonio (Bong) Nieva Carrion, the outgoing Governor of Marinduque. 2.Victoria Nieva married Doroteo Mercader 3.Dionisio Nieva married Salud de la Santa 4.Gregorio Nieva married Maria Arevalo 5.Jose Nieva married Trinidad Carmona 6.Rosita Nieva married Dr Angel Mayuga Rene's invitation also included the descendants of the brothers of Calixto, namely Pedro and Francisco Nieva. It also included the brothers and sisters of Epifania Morente, which included not just the Morentes but also the Roceses, Abadas, Trinidads and the Kasilags. Incidentally, the Reyeses are second cousins of Macrine and the other Nievas of Marinduque. This article will concentrate on the descendants of Juan Nieva and his two wives, Isabel Decena from Santa Cruz and Elvira Sarmiento from Buenavista.. Children of Juan Nieva and Isabel Decena ( from Oldest to Youngest) 1.Calixto Nieva married Juanita Jambalos 2.Blanca Nieva- single was killed by the Japanese during World War II 3.Elena Nieva married Bernardo Jambalos, Jr ( brother of Juanita) Children of Juan Nieva and Elvira Sarmiento(from Oldest to Youngest) 1.Guillermo ( Willie) Nieva married Dr Celina Elizalde 2.Rosario Nieva married Ramon Carrion 3.Ester Nieva married Rafael Seno 4.Monica Nieva married Conrado Luarca 5.Elizabeth Nieva married Romulo Santo Domingo 6.Asuncion Nieva married Dr. Rafael Ocampo 7.Fr Constantino Nieva- single For the purpose of this article, I will discuss only the descendants of Elena Nieva and Bernardo Jambalos, Jr. They have seven children as follows: ( From Oldest to Youngest) 1.Macrine Nieva Jambalos- married David B Katague from Iloilo ( that's me) 2.Sister Guia Jambalos- Order of the Cenacle-single 3.Bernardo Jambalos III married Loreta Mercader 4.Fe Jambalos married Edgardo Lazarte 5.Edgar Jambalos ( deceased) married Asuncion Pagalunan 6.Jean Jambalos married Mitch Maeda 7.Rosario Jambalos married Michael Levin Note that Rene Nieva is the oldest son of Guillermo Nieva and Dr. Celina Elizalde. The younger brother of Rene, Yong is my partner in our literary project, I left my Heart in Marinduque ( not San Francisco). http://marinduqueonmymind.blogspot.com Macrine's telephone buddy and first cousin from Vancouver, BC, Canada Olga Luarca Quiazon is the oldest daughter of Monica and Conrado Luarca The outgoing governor of Marinduque is the second son of Rosario Nieva and Ramon Carrion This posting continues with the offspring of Macrine Jambalos and David B. Katague. They have 4 children and six grandchildren as follows: 1.Dodie( Diosdado) Katague married Ruth Carver- They have 3 children, Philip Winchester, Alexandra and Marina Katague 2.Dinah E Katague married David E King- They have 2 children, Ian and Elaine King 3.David E III-single 4.Ditas Macrine Katague married Nick Thompson- They have one child, Carenna Nicole Thompson Fe Jambalos has two daughters, Lanie and Ella Jean Jambalos has two daughters, Yuri and Yuka Rosario has two children, Carlos and Zehara Asuncion and Edgar( deceased) Jambalos has three sons, Edmund, Nonoy and Jhun-Jhun and a daughter, Marilyn Bernardo Jambalos III has five children and three grandchildren as of this writing date. Accomplishments of the children of David B and Macrine J. Katague are discussed in detail at http://theintellectualmigrant.blogspot.com Some Interesting Vignettes: The marriage of Calixto and Juanita Jambalos was not approved by their father Don Juan Nieva. Juanita was the daughter of a barrio businessman from Laylay. During those time, if you are from the barrios, you are not welcome or accepted to the social group of the main town of Boac. The Jambalos family although well off were considered TAGABUKID ( from the bonies). Don Juan Nieva wanted his lawyer son to marry Enriqueta Nepomuceno, one of the popular socialites in Boac. When Juanita died, Calixto did not marry again. Soon Calixto also died and every one in town claimed he died with a broken heart. Enriqueta in the meantime was waiting for Calixto. Enriqueta never married and died as a spinster. Blanca Nieva graduated from Nursing School at Philippine General Hospital and was earning well. When their father died, she helped in sending her half-sister Rosario to College. She supported her sister and spoiled her by dressing her up to maintain her place in the high society of Boac at that time. Elena, is the third child of Isabel Decena from Santa Cruz. Isabel died giving birth to Elena. Elena was therefore nursed by the sister of Isabel, Regina Decena Reforma. Elena and Policarpio Reforma ( son of Regina) shared the same breast milk of Tia Regina. When Elena was five years old, she and sister Blanca as well as brother Calixto, were brought to Boac where their father Juan Nieva remarried Elvira Sarmiento from Buenavista. Elena grew up under the care of Lola Victoria ( sister of Juan Nieva). They lived in the old Nieva Building at the foot of the hill leading to Mataas Na Bayan. Elena later went to college at the University of the Philippines and finished her Bachelor Degree in Education. When Juanita Jambalos-Nieva( wife of Calixto) died during childbirth, Elena and Bernardo Jambalos II ( brother of Juanita) were made in-charged of bringing the corpse from Manila back to Marinduque. During the trip, people mistook them as husband and wife. Their romance started then and later were married at the Boac Catholic Church. Today, if I had to guess, there should be more than seven hundred members of the Nieva clan, just based on the six children of Calixto Nieva and Epifania Morente all over the world. If you include the descendants of Pedro and Francisco Nieva, the two brothers of Calixto, it could reached to more than a thousand Nievas all over the universe. If you are a member of this clan, please let me know. Someday, I may be able to trace the Nieva genealogy all the way to Spain, as I did with my mothers name "Balleza", several years ago. My e-mail is in this site and I am also in Face Book.

Death Valley National Park

Death Valley National Park is a national park located east of the Sierra Nevada in the arid Great Basin of the United States. Parts of the park are in southern Inyo County and northern San Bernardino County in Eastern California, with a small extension into southwestern Nye County and extreme southern Esmeralda County in Nevada. In addition, there is an exclave (Devil's Hole) in southern Nye County. The park covers 5,262 square miles (13,630 km2), encompassing Saline Valley, a large part of Panamint Valley, almost all of Death Valley, and parts of several mountain ranges. Death Valley National Monument was declared a U.S. National Monument in 1933, placing the area under federal protection. In 1994, the monument was redesignated a national park, as well as being substantially expanded to include Saline and Eureka valleys. It is the hottest and driest of the national parks in the United States. The second-lowest point in the Western Hemisphere is in Badwater Basin, which is 282 feet (86 m) below sea level. The park is home to many species of plants and animals that have adapted to this harsh desert environment. Some examples include creosote bush, Bighorn Sheep, Coyote, and the Death Valley Pupfish, a survivor of much wetter times. Approximately 95% of the park is designated as wilderness. Its wilderness area covers 4,774 square miles (12,360 km2), making it the largest in the Lower 48 states, and the sixth largest in the United States overall. Death Valley National Park is visited annually by more than 770,000 visitors who come to see its diverse geologic features, desert wildlife, historic sites, scenery, and clear night skies. Mining was the primary activity in the area before it was protected. The first documented non-Native Americans to enter Death Valley did so in the winter of 1849, thinking they would save time by taking a shortcut to the gold fields of California. They were stuck for weeks and in the process gave the valley its name, even though only one of their group died there. Several short-lived boom towns sprang up during the late 19th and early 20th centuries to exploit minor local bonanzas of gold. The only long-term profitable ore to be mined, however, was borax, a mineral used to make soap and an important industrial compound. Today, borax is an essential component of high-temperature resistant boro-silicate glass products, for example Pyrex cookware. Twenty-mule teams were used to transport ore out of the valley; helping to make it famous and the subject of books, radio programs, television series, and movies.

The natural environment of the area has been shaped largely by its geology. The valley itself is actually a graben. The oldest rocks are extensively metamorphosed and at least 1.7 billion years old. Ancient warm, shallow seas deposited marine sediments until rifting opened the Pacific Ocean. Additional sedimentation occurred until a subduction zone formed off the coast. This uplifted the region out of the sea and created a line of volcanoes. Later the crust started to pull apart, creating the current Basin and Range landform. Valleys filled with sediment and, during the wet times of glacial periods, with lakes, such as Lake Manly.

Note: This is No.9 of the series of articles on popular national parks in US.