Chlorine Dioxide Incident Reports Case 4023 Jonathan Chen, Ph. D. Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 February 23, 2006 TABLE OF CONTENTS 0.0 INTRODUCTION................................................................................................................................................ 3 1.0 INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS ............................................... 3 1.1 OPP =

S INCIDENT DATA SYSTEM ( IDS) .............................................................................................................. 4 1.2 POISON CONTROL CENTER ( 1993   2003)........................................................................................................ 4 1.3 CALIFORNIA DATA  1982 THROUGH 2003........................................................................................................ 5 1.4 NATIONAL PESTICIDE TELECOMMUNICATIONS NETWORK ( NPTN)................................................................. 5 1.5 INCIDENT REPORTS / EPIDEMIOLOGICAL STUDIES PUBLISHED IN SCIENTIFIC LITERATURE. ........................... 5 1.5.1 Respiratory Effects ........................................................................................................................................ 5 1.5.2 Ocular Effects................................................................................................................................................ 7 1.5.3 Dermal Effects............................................................................................................................................... 8 1.5.4 Oral Effects.................................................................................................................................................... 8 1.4.5 Other Related Effects .................................................................................................................................. 10 2.0 SUMMARY AND CONCLUSION.................................................................................................................. 11 3.0 REFERENCE...................................................................................................................................................... 18 Page 3 of 22 0.0 INTRODUCTION The chemical chlorine dioxide ( ClO2) is used as a biocide in bleaching cellulose, paper and pulp, flour, leather, fats and oils, textiles, and beeswax; in purification of water; for taste and odor control of water; in cleaning and detanning leather; in the manufacturing of chloride salts; as an oxidizing agent; as a bactericide, antiseptic and deodorizer ( The Merck Index, 2001). The purpose of this chapter is to review the evidence of health effects in humans resulting from exposure to chlorine dioxide.

Two approaches are used in this section:

1. The potential health effects of chlorine dioxide in humans, reported as incident reports from different sources, are summarized.

2. A literature search of chronic health effects associated with chlorine dioxide exposure, including results of epidemiological studies, is summarized.

1.0 INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS The following databases have been consulted for the poisoning incident data OPP Incident Data System ( IDS)  The Incident Data System of The Office of Pesticide Programs ( OPP) of the Environmental Protection Agency ( EPA) contains reports of incidents from various sources, including registrants, other federal and state health and environmental agencies, and individual consumers, submitted to OPP since 1992. Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated. Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects. Nevertheless, with enough cases and/ or enough documentation, risk mitigation measures may be suggested.

Poison Control Centers  as a result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 2003 for all pesticides. Most of the national Poison Control Centers ( PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System, which obtains data from about 65 70 centers at hospitals and universities. PCCs provide telephone consultation for individuals and health care providers on suspected poisonings, involving drugs, household products, pesticides, etc.

California Department of Pesticide Regulation  California has collected uniform data on suspected pesticide poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers. Information on exposure ( worker activity), type of illness ( systemic, eye, skin, eye/ skin and respiratory), likelihood of a causal relationship, and number of days off work and in the hospital are provided.

National Pesticide Telecommunications Network ( NPTN)  NPTN is a toll free information Page 4 of 22 service supported by OPP. A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984 1991, inclusive, has been prepared. The total number of calls was tabulated for the categories human incidents, animal incidents, calls for information, and others.

Published Incident Reports  Some incident reports associated with chlorine dioxide related human health hazards are published in the scientific literature.

1.1 OPP =

s Incident Data System ( IDS)

Four incidents have been reported that are associated with chlorine dioxide in the OPP incident data system. These incidents are listed below.

1) In October 1995, fogging was done in the air vents of an occupied apartment building with the product Envirocon. A woman complained that she had a headache afterwards.

2) In September 1995, a failure in the chlorine dioxide reservoir sensor caused a temporary overload of chlorine into the fish thawing line in the processing building of Bumble Bee Seafood. Sixty six employees were evacuated and three of those employees went to the doctor when they experienced symptoms of headache, nasal congestion, eye irritation, nausea and dizziness. All three employees were back at work the following day.

3) In July 2000, a power outage caused the chlorine system at a Smuckers plant to surge. The exhaust system was also not operational. The combination caused a strong odor of chlorine. Five workers on the strawberry processing line complained of the smell and experienced itchy watery eyes, runny nose, sore throat and headache. A total of six workers saw physicians.

4) In May 1999, equipment operators standing near a bottle cooler complained of fumes and said the fumes were giving them headaches and sore throats. The water in the bottle cooler had been treated with Akta Chlor 25 which contains chlorine dioxide as the active ingredient.

For comparison, these incidents are summarized in Table 1. Inhalation exposure is the primary route of exposure. Irritation type reactions and headache are the primary concerns that have been reported.

1.2 Poison Control Center  1993 through 2003 There are no chlorine dioxide specific incidents that have been reported. Page 5 of 22 1.3 California Data  1982 through 2003 There are 20 incidents that have been reported in the California Pesticide Surveillance Program Database ( 1982 2003) as possibly or probably chlorine dioxide related ( summarized in Table 2). Eleven of these reported incidences are not agriculturally related. Lightheadedness, headache, nausea, coughing, throat irritation, sinus tightness, difficulty breathing and chest tightness are the common symptoms reported in these incidents. Table 3 presents the types of illnesses reported by year. Table 4 gives the total number of workers that took time off work as a result of their illness and how many were hospitalized and for how long.

1.4 National Pesticide Telecommunications Network ( NPTN)

There is no incident reported in the NPTN database related to chlorine dioxide.

1.5 Incident Reports / Epidemiological Studies Published in Scientific Literature.

Both chlorine and chlorine dioxide dissolve in water, then hydrolyze to produce hypochlorous acid and hypochlorite ion. These breakdown products tend to react in a swimming pool with the organic content, temperature and pH to produce predominant breakdown by products which were identified in WHO ( 2000) as trihalomethanes ( e. g., chloroform), chloramines, haloacetic acids, haloacetonitriles, haloketones, chloropicrin, and chloral hydrate. When it is in an aqueous media, it is difficult to separate incidents associated with chlorine dioxide from incidents associated with chlorine, chlorite and hypochlorite ions. Therefore, some of the incidents associated with all the related chemicals will also be discussed.

1.5.1 Respiratory Effects The most common symptoms reported for cases of inhalation exposure were respiratory irritation/ burning, irritation to mouth/ throat/ nose, coughing/ choking, shortness of breath, dizziness, flu like symptoms, and headache. A chlorine dioxide concentration of 5 ppm was definitely irritating. Concentrations averaging between trace and 0.25 ppm were associated with minor respiratory ailments. A concentration of 19 ppm can cause death ( ACDIH, 2001).

A woman gardener 49 years of age suffered inhalation intoxication from chlorine dioxide while bleaching dried flowers. Preparation of the bleaching solutions was associated with a sharp pungent smell, coughing, pharyngeal irritation and headache. Seven hours later increasing cough and dyspnea led to hospitalization. Clinical findings were tachypnea, tachycardia, and rales of auscultation; clinical chemistry revealed marked leucocytosis. Chest X ray did not yield any abnormal findings. Initially the vital capacity and forced expiratory volume in 1 sec markedly reduced and the resistance correspondingly enhanced. Blood gas analysis showed hypoxemia despite alveolar hyperventilation. Administration of corticosteroids resulted in significant alleviation of complaints and in improved lung function with stabilization in a highly normal range, as Page 6 of 22 confirmed by follow up examination two years later. The chlorine dioxide intoxication had been due to pH level reduction resulting from an incorrect proportioning and handling of the individual bleaching agent components when preparing the solution ( Exner Freisfeld et al., 1986 cited in HSDB).

Potts ( 1996) reported that the general symptoms of complaints from most swimmers treated with chlorinated disinfectants are upper and lower respiratory tract symptoms such as coughing, chest tightness, wheezing and dyspnea. They stated that other symptoms may include headaches, nausea, lethargy, soar throat, and irritation of the eyes, nose and throat. Other complaints have been diagnosed to include mild bronchial irritation of the swimmer's airways ( Rycroft and Penny, 1983). Mustchin and Pickering ( 1979) found that many competitive swimmers experienced coughing, soar throat, and chest tightness. In one incident three children were diagnosed with reversible airway obstruction. Zwick et al. ( 1990) have reported that competitive swimmers had a higher prevalence of allergies and subclinical sensitization to aeroallergens, altered cellular immunity, and non specific bronchial hyper responsiveness.

Potts ( 1996) also reported the results of a comprehensive survey of 738 competitive swimmers conducted previously ( Potts, 1994) which indicated that bronchitis ( 24.9%), hay fever ( 16.9%), asthma ( 13.4%) and pneumonia ( 10.2%) were experienced most frequently among swimmers. Survey participants ( 73.8%) reported smelling a strong chemical odor in the swimming pool. The symptoms the swimmers associated with the odor included coughing ( 40.9%), breathing difficulty ( 36.4%), sore eyes ( 26.3%), sneezing ( 25.2%), sore throat ( 22.9%), headaches ( 22%), chest congestion ( 21.3%), chest tightness ( 21.0%) wheezing ( 20.9%) and nausea ( 11.7%).

Helenius et al. ( 1998), Drobnic et al. ( 1995), Rothery ( 1991), and Rycroft and Penny ( 1983) reported increased bronchial responsiveness in elite swimmers and also reported that long term and repeated exposure to chlorine compounds in swimming pools during training and competition may contribute to the increased occurrence of asthma, bronchial hyperresponsiveness and airway inflammation in swimmers.

Trichloramine levels were measured in the atmosphere of indoor swimming pools and the results indicated that life guards are at risk of developing irritant eyes, nasal and throat symptoms ( WHO, 2000). A relationship between bronchial hyperresponsiveness and exposure initially had not been found, however, WHO ( 2000) did not rule out the possibility that lifeguards may be at risk of developing transient bronchial hyperresponsiveness.

Small and Murray ( 1987) presented the results of a controlled trial of ten swimmers which studied the acute effects on nasal mucosa as a result of swimming in a chlorinated pool. The results are reported to indicate that sodium hypochlorinated water in concentrations of three parts per million does not have any short term effect on nasal mucosa, despite prolonged immersion. Morgan and Shenoi ( 1989) reported that swimming in chlorinated water does not affect eustachian tube function. Page 7 of 22 1.5.2 Ocular Effects From the cited literature, it appears that chloramines in the chlorinated pool water may cause ocular effects manifested by symptoms such as red, watery eyes. Chloramine causes irritation of the conjunctiva and effects the mucous membranes of the eye causing eye irritation ( conjunctival chemosis, hypermia, corneal epithelial erosions, and edema) and possibly temporary vision problems. One study ( Rylander et al., 1973) indicated that the difference in concentration of free chlorine and pH may cause increasing levels of eye irritation. Below is a summary of the literature for ocular hazards.

Chloramines are known to cause irritation of the conjunctiva and effects on mucous membranes of the nasopharynx. Haag and Gieser ( 1983) reported the results of their study which found that 68% of subjects saw rainbows and/ or halos around lights after swimming in a chlorinated pool. A large percentage ( 94%) of subjects had corneal epithelial erosions in a punctate or a linear pattern demonstrated by fluorescein staining on slit lamp examination. Visual acuity was not decreased in any of the subjects. Increasing the chlorine concentration from 0.05 to 0.5 ppm produced a slight increase in eye irritation.

Chiswell and Wildsoet ( 1989) reported that chloramines may be responsible for eye irritation such as conjunctival chemosis and hyperemia, along with corneal epithelial erosions and/ or edema. The symptoms may include blurred vision, halo effects, photophobia and sore or burning eyes. In another study, Chiswell and Wildsoet ( 1986) reported that superficial punctate keratitis may be caused by exposure to chlorinated swimming pool water. They noted that pool water toxicity, pH and a variety of chlorine species ( e. g., hypochlorite, chloramines) may impact such reactions. They also noted that a gaseous form of chloramines collect above pool water in sufficient concentration to cause eye irritation. Verhulst and Crotty ( 1971) also noted eye irritation from swimming in disinfected pools as a frequent occurrence.

Rylander et al. ( 1973) found slight eye irritation in certain subjects when water was applied containing 1.0 mg Cl2/ L. At 2.0 mg CL2/ L, the irritation was found to be greater. Variations of pH between seven and nine showed no significant influence. Different individuals showed different sensitivities to irritations of the eye. Eye irritation was decreased when the time spent in the pool was less than 30 minutes.

Hery et al. ( 1995) reported that chloramines, and specifically nitrogen trichloride, are the likely irritants ( ie. eye, lung and throat) and lachrymators in the atmosphere of indoor swimming pools. Good correlations were found for chloramine concentrations and irritation levels. The first complaints from participants in the study were registered at 0.5 mg/ m 3 of nitrogen trichloride. At 0.7 mg/ m 3 of nitrogen trichloride, all participants complained of irritation.

Momas et al. ( 1993) maintain the health effects for subjects attending a well kept school swimming pool, maintained according to French public health regulations. The authors found that bathers experienced fatigue and eye irritation significantly more often ( p < 0.001) than non bathers. The eyes were red ( 38% of bathers) and/ or watery ( 16%) after swimming, but this resolved Page 8 of 22 spontaneously within 24 hours. Bathing behavior ( bath duration, head immersion, wearing swimming goggles) did not affect these incident rates noticeably. There were no differences between bathers and non bathers with regard to other symptoms, especially otolaryngological ones.

1.5.3 Dermal Effects Dermal effects indicated in the cited literature include contact urticartia, a short burning sensation in the tip of the penis, and generalized rash. One author ( Fisher, 1987) indicated however that irritant dermatitis is uncommon and allergic reactions are rare. Below is a summary of the literature for dermal hazards.

Fisher ( 1987) noted that irritant dermatitis is uncommon and allergic reactions are extremely rare from chlorine. He reports that some men experience a burning sensation in the tip of their penis for a short time after swimming in chlorinated pools. During urination, this sensation is reported to be augmented. Dermatitis does not accompany these symptoms. One patient is reported to have acquired contact urticaria whenever he swam in a pool disinfected with sodium hypochlorite. The authors concluded that swimming pool water may result in contact urticaria.

Neering ( 1977) reported that a healthy 34 year old adult experienced intermittent urticaria after swimming in a pool disinfected with NaOCl. This reaction was further confirmed with patch tests. The authors recommended that contact urticaria from chlorinated swimming pool water should be borne in mind in patients suspected of aquagenic urticaria.

Ng and Goh ( 1989) reported that swimming in chlorinated water caused a generalized rash which lasted for one week in a 47 year old man. The individual was also found to have allergic contact dermatitis from flavine and from sodium hypochlorite.

Leung ( 1985) reported that a 3 year old girl developed erythema multiforme following swimming in an outdoor chlorinated pool. The erythematous rash occurred all over her body, face, and extremities. Generalized erythematous maculopapular eruption was noted after five days. The rash subsided within two weeks. The author cited other works that report chlorine may cause corneal epithelial erosions and bronchial irritation.

Sasseville et al. ( 1999) reported a case of diffuse dermatitis in an individual that swam in heavily chlorinated public pools and of hand dermatitis upon exposure to sodium hypochlorite bleach.

Valsecchi et al. ( 1985) reported an incidence of a pool worker that experienced a 6 month period of eczema affecting his feet and legs as a result of using Tego ( dodecylic aminoethyl glycine hydrochloride) ( 0.1% and 1% in water) for disinfecting the pool and baths.

1.5.4 Oral Effects Page 9 of 22 An investigation took place of workers exposed for 5 years to chlorine dioxide in a sulfite cellulose plant. Chlorine in small amounts was also present, as was sulfur dioxide. Symptoms and signs of irritation of the eyes and respiratory tract leading to slight bronchitis were found in a majority ( 7 of 12) of the workers. Some workers showed irritation of GI tract but no cerebral effects ( ACGIH, 2001 Cited in HSDB).

Two adults ingested 250 mL of chlorine dioxide in water containing concentration of 40 mg/ L. Within 5 min of ingestion, sudden headache, nausea, abdominal discomfort, and light headedness were observed. The reported effects disappeared within 5 min ( NRC, 1981).

Escartin et al. ( 2000) reported an increased prevalence of dental stains in competitive swimmers. They proposed that dental stains in swimmers are caused by the chemical used to disinfect the pool water. These disinfectants denature the saliva proteins which are deposited as a film on the surface of the tooth. Escartin et al. ( 2000) also proposed that the mixture of water with oral fluids produces inorganic substances which may be deposited together with the denaturized proteins on the teeth and that more than 6 hours of training per week increased the risks of dental stains.

Rose and Carey ( 1995) also reported that prolonged exposure to pool water can cause stains to develop on swimmers' teeth. ADAHF scientists have labeled brown dental deposits that form on the teeth of swimmers as " swimmers' calculus." Dental calculus is made up of organic and inorganic components. The relatively small organic components of calculus ( 15 to 25%) consist of plaque bacteria and bacterial remnants, as well as components from saliva and gingival fluid. The larger inorganic components consist of calcium phosphates, magnesium fluoride and carbonate. Dental calculus rarely forms in children younger than nine years of age. The authors reported that in a survey, approximately 58% of competitive swimmers between 6 and 18 years had swimmers calculus.

Centerwall et al. ( 1986) reported that erosion of dental enamel among competitive swimmers at a gas chlorinated swimming pool is due to prolonged exposure to pool water at low pH ( i. e. acidic). In another study, Prindle ( 1983) reported that a pool with a pH of 2.7 ( i. e. an acid concentration approximately 100,000 times that recommended for swimming pools) resulted in general enamel erosion in 13% of the subjects. Tooth enamel did not decalcify in acidic solutions unless the pH was below 6.0. Gabai et al. ( 1988) conducted a study investigating the effect of swimming pool water pH levels on the dissolution of powdered human tooth enamel and tooth surface morphology and concurred that frequent exposure to acidic swimming pool water may lead to possible tooth erosion.

Detweiler and Barelli ( 1995) reported that chlorinated swimming pool water may be linked to triggering the recurrent herpes simplex virus 1 ( HSV 1). The authors stated that the action of the chemical or chemicals in the swimming pool water on the oral mucosa or tongue may be responsible for the virus reactivation. They believed that chlorine or chlorine in combination with one or more of the chemicals frequently added to swimming pool waters ( e. g. bicarbonate of soda, calcium chloride, soda ash, muratic acid, alum, antioxidants and antifungal products) may be the triggering element for recurrent oral lingual herpes simplex virus 1. In a more recent report, Detweiler and Barelli ( 1997) reconfirmed that strenuous forty five to fifty minute swimming sessions in Page 10 of 22 chlorinated swimming pools will cause reactivation of oral lingual HSV 1.

1.4.5 Other Related Effects Other related effects of chlorinated pool water include inhalation of chloroform. At high doses, chloroform is toxic to the liver and kidneys and may be a chronic concern for sensitive individuals ( e. g. pregnant women) and people with liver and kidney problems. Chlorine gas and chlorine dioxide are strong irritants and may be of particular concern with accidental exposure to chlorine gas leaks in chlorination systems. At least one author concluded that chlorinated water may have acted as the oxidant trigger for an acute hemolytic crisis in a 7 year old boy with Down's syndrome and G 6 PD deficiency. Below is a summary of the literature.

Aiking, et al. ( 1994) reported that high doses of chloroform are toxic to the liver and kidneys. Since chloroform and other chlorinated compounds are volatile, high concentrations are found immediately above the water surface. Since inhalation is the main route of exposure, particularly high exposures are experienced by those who swim for a long time under high physical strain. They believed that people who swim in chlorinated swimming pools for many years at a stretch may be at risk and that swimming in chlorinated swimming pools at an early stage of development may also have undesirable consequences later in life.

Ong and Kearney ( 1994) reported that swimming in an indoor pool that used ozone and very high concentrations of sodium hypochlorite precipitated a hemolytic crisis in a 7 year old boy with Down's syndrome and G 6 PD deficiency. The authors concluded that the chlorinated water had acted as the oxidant trigger for the acute hemolytic crisis.

A study was carried out in 9 Italian towns between October 1999 and September 2000 that aimed to evaluate the association, if any, between chlorite and chlorate in drinking water and both preterm delivery and babies that are small for their gestational age at term. While controlling for numerous possible confounding factors, the study showed that there is an association between babies that are small for their gestational age at term and chlorite in drinking water when the chlorite levels are greater than 200 µ g/ L and there is high exposure from both ingestion and inhalation ( from daily showering and bathing). However, as the authors point out, this association may be due to a different disinfection byproduct produced by chlorine dioxide or to a not yet identified confounding factor. There was no correlation between preterm delivery and exposure to chlorite or chlorate in drinking water ( Aggazzotti et al. 2003).

A study was carried out to investigate the possible association between maternal periconceptional exposure to public drinking water chlorination byproducts and the incidence of congenital cardiac defects in a Swedish county between January 1, 1982 and December 31, 1996. Information in Swedish health registers was linked with information on municipal drinking water composition. Individual data on drinking water composition was obtained for 58,669 women. Among the infants born to these women, 753 had a cardiac defect. Chlorine dioxide use in disinfection was found to be an independent risk factor for cardiac defect and so was increasing trihalomethane concentrations ( THM concentrations higher than 10 µ g/ L were statistically significantly associated with cardiac Page 11 of 22 defects). The study concluded that the individual risk for cardiac defect caused by chlorine dioxide is small, but because a large population is exposed to public drinking water, " the attributable risk for cardiac defects may not be negligible" ( Cedergren et al., 2002).

An epidemiologic study of 198 persons exposed for 12 weeks to drinking water that had been disinfected with chlorine dioxide was conducted in a rural village. A control group of 118 nonexposed persons was also studied. Chlorite ions in the water averaged 5.28 ppm during the study period. Based on water consumption information, the mean chlorite dose received was 10.3 mg/ day and the range 0 39.4 mg/ day. Statistical analysis of multiple hematologic and serum clinical chemistry measurements failed to identify any significant adverse health effects related to exposure ( Michael et al., 1981).

A study of the blood chemistry parameters of 20 renal dialysis patients was conducted after it was found out that a local water district had introduced chlorine dioxide as a disinfectant for 12 months without informing the renal dialysis clinic. Renal dialysis patients are considered to be more sensitive to chemicals in tap water than the general population because not only are they in a compromised state of health, but while the average population consumes 1 2 liters of tap water per day, about 100 125 liters of tap water is used during the process of renal dialysis. However, the chlorination products measured at the clinic after it had purified the water used in the preparation of the dialysate consisted only of 0.02 0.08 mg/ L chlorite. No evidence of chlorine dioxide induced anemia was found and no other clinically significant effects were observed ( Ames and Stratton, 1987).

2.0 SUMMARY AND CONCLUSION There are incidents associated with chlorine dioxide exposure reported in both the OPP Incident Data System and the California Department of Pesticide Regulation Database ( 1982 2003). Among the reported incidents in these databases, inhalation is the primary route of exposure. Irritation is the primary reported symptom.

When it is in aqueous media, it is difficult to separate incidents associated with chlorine dioxide from incidents associated with chlorine, chlorite and hypochlorite ions. Therefore, some of the incidents associated with the related chemicals are also discussed. Inhalation, dermal, ocular, oral, and other health concerns are reported. Page 12 of 22 Table 1. Incidents Associated with Chlorine Dioxide  OPP Incident Data System ( IDS)

Package Information Route of Exposure Causality Incident Data Package ID Incident Number Product Name Data Incident was Reported Dermal Ocular Ingestion Inhalation Unknown Eye Irritation/

Burning Itching Vomiting/

Nausea Nasal Congestion/

Runny Nose Sore Throat Headache Dizziness Unknown Likely Possible Unlikely I002913 1 Envirocon 12/ 6/ 95 x x x I003377 16 Akta Klor 9/ 27/ 95 x x x x x x x I010817 1 Chlorine Dioxide 10/ 19/ 00 x x x x x x x I008802 2 Akta Klor 25 5/ 31/ 99 x x x x Page 13 of 22 Table 2. Case Reports Received by the California Pesticide Illness Surveillance Program, 1982   2003 in Which Health Effects Were Definitely, Probably, or Possibly Attributed to Exposure to Chlorine Dioxide Year Case Identified Case Number( a) Relationship( b) Days Lost from Work / Days Hospitalized ( c) Ag /

Non Ag ( d) Medical Description ( e) Narrative Description 1990 848 Probable 4 / 0 Non Ag SMELLED CHLORINE DEVELOPED BREATHING DIFICULTY, HEADACHE, COUGH, DIZZINESS.

DIAGNOSED BRONCHIAL IRRITATION. SAFETY EQUIPMENT NOT REPORTED. CHLORINE DIOXIDE DELIVERY SYSTEM DID NOT WORK CORRECTLY THAT DAY.

1990 1478 Probable 0 / 0 Non Ag WORKER APPLYING MATERIAL FROM SPRAY BOTTLE GOT FUMES IN EYES AND LUNGS CAUSING BURNING. SHE ALSO SUFFERED FROM COUGHING AND SHORTNESS OF BREATH. SHE WORE ONLY RUBBER GLOVES FOR PROTECTION.

NOV ISSUED FOR USE OF AN UNREGISTERED PRODUCT AND FOR NO TRAINING 1990 2474 Probable 0 / 0 Non Ag DISINFECTANT USED IN A MEAT PACKING FACILITY OVER A PERIOD OF TIME CAUSED A FEMALE EMPLOYEE TO DEVELOP SOB, LIGHT HEADEDNESS AND THROAT IRRITATION FROM CONSTANT EXPOSURE DUE TO INHALATION.

EMPLOYEE WEARING PROPER CLOTHING AND RUBBER GLOVES. DIAGNOSIS CHE 1991 2230 Possible UN / 0 Non Ag MODERATE CONJUNCTIVAL HYPEREMIA OF BOTH EYES. WORKER WAS SORTING TOMATOES ON A SORTING BELT. WATER FROM THE WATER BATH WAS SPLASHING ONTO THE SORTING BELT AND SOME SPLASHED UP INTO HER EYES. SHE IMMEDIATELY FLUSHED HER EYES OUT AND PUT EYE DROPS IN THEM. SHE THEN SOUGHT MEDICAL ATTENTION.

1991 2574 Probable 0 / 0 Ag BRONCHOSPASM. MECHANICAL PROBLEMS CAUSED BY A SORTING FLUME BACK UP, ALLOWING AN EXCESSIVE AMOUNT OF CHLORINE DIOXIDE TO BE INJECTED INTO THE SYSTEM. THREE WORKERS WERE EXPOSED TO THE CHLORINE FUMES AND SOUGHT MEDICAL ATTENTION. Page 14 of 22 1991 2575 Probable 0 / 0 Ag PNEUMONITIS,

VOMITING, COUGHING. MECHANICAL PROBLEMS CAUSED BY A SORTING FLUME BACK UP, ALLOWING AN EXCESSIVE AMOUNT OF CHLORINE DIOXIDE TO BE INJECTED INTO THE SYSTEM. THREE WORKERS WERE EXPOSED TO THE CHLORINE FUMES AND SOUGHT MEDICAL ATTENTION. Page 15 of 22 Table 2. Case Reports Received by the California Pesticide Illness Surveillance Program, 1982   2003 in Which Health Effects Were Definitely, Probably, or Possibly Attributed to Exposure to Chlorine Dioxide ( Continued)

Year Case Identified Case Number ( a) Relationship ( b) Days Lost from Work / Days Hospitalized ( c) Ag / Non Ag ( d) Medical Description ( e) Narrative Description 1994 847 Possible 0 / 0 Ag RESPIRATORY IRRITATION,

COUGHING,

DIZZINESS, SLIGHT BACK AND CHEST DISCOMFORT. FOUR WORKERS NOTICED AN ODOR WHILE INSPECTING ONIONS ON A CONVEYOR BELT AND BECAME ILL.

THE ONIONS ARE PRESSURE WASHED WITH CHLORINATED WATER UNDER A SHIELDED HOOD. SEE ALSO 94 848 TO 850.

1994 848 Possible 0 / 0 Ag THROAT IRRITATION,

DRY COUGH. SEE 94 847.

1994 849 Possible 0 / 0 Ag COUGHING, THROAT IRRITATION, NAUSEA. SEE 94 847.

1994 850 Possible 0 / 0 Ag COUGHING, MILD RHINORRHEA,

NAUSEA. SEE 94 847.

1994 930 Possible 0 / 0 Non Ag COUGHING, THROAT IRRITATION, SHORTNESS OF BREATH, WATERING EYES. WORKER SUFFERED RESPIRATORY AND EYE PROBLEMS WHILE INSPECTING ONIONS ON A CONVEYOR BELT. THE ONIONS HAD BEEN WASHED IN A CHLORINATED SOLUTION. SHE SOUGHT MEDICAL ATTENTION FOUR DAYS LATER.

1994 1030 Possible 0 / 0 Non Ag BURNING EYES,

COUGHING, NAUSEA,

HEADACHE. WORKER WAS INSPECTING ONIONS AND WAS EXPOSED TO FUMES FROM THE CHLORINE WASH. Page 16 of 22 Table 2. Case Reports Received by the California Pesticide Illness Surveillance Program, 1982   2003 in Which Health Effects Were Definitely, Probably, or Possibly Attributed to Exposure to Chlorine Dioxide ( Continued)

Year Case Identified Case Number ( a) Relationship ( b) Days Lost from Work / Days Hospitalized ( c) Ag / Non Ag ( d) Medical Description ( e) Narrative Description 1997 237 Probable UN / 0 Ag CHEST TIGHTNESS. A CHLORINE DIOXIDE PIPE EXPLODED IN A CARROT PACKING PLANT. FIFTEEN FEET AWAY, A WORKER CLEANING A TANK SMELLED CHLORINE AND JUMPED FROM THE TANK. THE JUMP INJURED HIS LEG AND BROKE HIS FOOT. HE ALSO COMPLAINED OF TRANSITORY CHEST TIGHTNESS.

1997 1040 Possible 4 / 0 Non Ag RESPIRATORY IRRITATION,

COUGHING, EYE IRRITATION. CHLORINE DIOXIDE WAS BEING ADDED TO WATER IN A TANK WHILE AN EMPLOYEE WAS OPERATING A CANNING MACHINE. SHE WAS EXPOSED TO THE FUMES AND DEVELOPED SYMPTOMS. SHE SOUGHT MEDICAL ATTENTION 4 DAYS LATER.

1997 1096 Probable 0 / 0 Non Ag SORE THROAT,

STOMACH ACHE, CONSTIPATION,

PAIN AND TIGHTNESS IN THE CHEST,

COUGHING. CHLORINE DIOXIDE WAS BEING USED AS A SANITIZING RINSE ON PACKING PLANT EQUIPMENT,

WHEN A POWER LOSS OCCURRED. THIS SHUT OFF A VENTING FAN SO THE CHLORINE DIOXIDE VENTED INTO A ROOM OF WORKERS. SEE 97 1103 AND 1104.

1997 1103 Probable 0 / 0 Non Ag WHEEZING, COUGHING. SEE 97 1096. THREE WORKERS DEVELOPED SYMPTOMS AND SOUGHT MEDICAL ATTENTION.

1997 1104 Probable 0 / 0 Non Ag SORE THROAT,

COUGHING, EYE IRRITATION,

NAUSEA. SEE 97 1096.

2001 354 Possible 0 / 0 Ag COUGHING, HEADACHE,

VOMITING. TWO PROCESSING PLANT EMPLOYEES DEVELOPED SYMPTOMS WHILE WORKING ON THE STRAWBERRY PROCESSING LINE. THIS EMPLOYEE SORTED STRAWBERRIES ON A CONVEYOR BELT. LAB REPORTS SHOWED THE WASH WATER CHLORINE LEVELS A LITTLE HIGH 5 TIMES THAT DAY. SEE 2001 355. Page 17 of 22 Table 2. Case Reports Received by the California Pesticide Illness Surveillance Program, 1982   2003 in Which Health Effects Were Definitely, Probably, or Possibly Attributed to Exposure to Chlorine Dioxide ( Continued)

Year Case Identified Case Number ( a) Relationship ( b) Days Lost from Work / Days Hospitalized ( c) Ag / Non Ag ( d) Medical Description ( e) Narrative Description 2001 355 Probable 0 / 0 Ag COUGHING, CHEST PAIN, SORE THROAT, HEADACHE. SEE 2001 354. THIS EMPLOYEE DUMPED CRATES OF STRAWBERRIES INTO THE CHLORINATED WASH TANK WATER.

2001 937 Possible UN / 0 Non Ag SORE THROAT, DRY AND IRRITATED NOSE, COUGHING,

NAUSEA, LIGHTHEADEDNESS. A MAILROOM CLERK DEVELOPED SYMPTOMS WHEN A TECHNICIAN DISINFECTED THE VENTILATION SYSTEM. THE NEXT DAY, SHE REPORTED HER SYMPTOMS TO THE SUPERVISOR WHO SENT HER FOR A MEDICAL EVALUATION. SHE NO LONGER WORKS AT THE COMPANY AND COULD NOT BE LOCATED.

Note:

( a) Case numbers are assigned sequentially from 1 each year.

( b) A relationship of ` Definite' indicates that both physical and medical evidence document exposure and consequent health effects.

` Probable' relationship indicates that limited or circumstantial evidence supports a relationship to pesticide exposure.

` Possible' relationship indicates that evidence neither supports nor contradicts a relationship .

( c) Counts full days only. An entry of ` Indefinite' indicates the event occurred, but the time period is not known. UN = unkown.

( d) The abbreviation ' Ag' stands for ' Agricultural' and indicates pesticide use intended to contribute to production of an agricultural commodity. All other situations are designated ' Non Ag'.

( e) The medical description field was added to the database in 1991. Page 18 of 22 Table 3: Cases Due to Chlorine Dioxide Exposure in California Reported by Type of Illness and Year, 1982 2003 Illness Type Year Systemic Mouth Eye Skin Respiratory Combinationa Total 1990     3  3 1991 1  1  2 1 3 1994 2    4 2 4 1997     4  4 2001 1 1 2 2  1 5 Total 4 1 3 2 13 4 19 a Category includes combined effects to eye, skin, mouth and respiratory systems.

Table 4: Number of Persons Disabled ( taking time off work) or Hospitalized for Indicated Number of Days after Chlorine Dioxide Exposure in California, 1982 2003.

Number of Persons Disabled Number of Persons Hospitalized One day

Two days

3 5 days 2

Unknown 3  Page 19 of 22 3.0 REFERENCES Aggazzotti, G; Fabiani, L.; Triassi, M,; Sciacca, S.; Ravera, G.; Kanitz, S.; Barbone, F.; Sansebastiano, K.; Battaglia, M. A.; and Leoni, V. 2003 Exposure to chlorite and chlorate in drinking water and adverse pregnancy outcomes in Italy. Epidemiology. 14 ( 5): S24.

Aiking H., Van Acker M. B., Scholten R. J. P. M., Feenstra J. F., and Valkenburg H. A. ( 1994) Swimming pool chlorination: A health hazard? Toxicology Letters ( 1 3): 375  380.

American Conference of Governmental Industrial Hygienists ( ACGIH) 2001. Documentation of Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices.

Ames, R. G. and Stratton, J. W, 1987.. Effect of chlorine dioxide water disinfection on hematologic and serum parameters of renal dialysis patients. Archives of Environmental Health.: 42( 5): 280 285.)

Cedergren, M. I.; Selbing, A. J.; Lofman, O.; and Kallen, B. A. J. 2002 Chlorination byproducts and nitrate in drinking water and risk for congenital cardiac defects. Environmental Research Section A. 89: 124 130.

Centerwall B. S., Armstrong C. W., Funkhouser L. S., and Elzay R. P. ( 1986) Erosion of dental enamel among competitive swimmers at a gas chlorinated swimming pool. American Journal of Epidemiology 123 ( 4): 641  647.

Chiswell B. and Wildsoet C. F. ( 1986) On the possible sources of ocular irritation in chlorinated swimming pools. Clinical and Experimental Optometry ( 5): 178  182.

Chiswell B., Wildsoet C. F., Lanfermann U., Erdinger L., and Sonntag H. G. ( 1989) The causes of eye irritation in swimming pools. Assessment of eye irritations by swimming pool water in the het cam test investigations. International Association on Water Pollution Research and Control Conference on Water Quality and Management for Recreation and Tourism 21( 2): 241  244.

Decker W. J. ( 1988) Chlorine poisoning at the swimming pool revisited: Anatomy of two minidisasters. Veterinary and Human Toxicology 30 ( 6): 584  585.

Decker W. J. and Koch H. F. ( 1978) Chlorine poisoning at the swimming pool: An overlooked hazard. Clinical Toxicology ( 3): 377  381.

Detweiler M. B. and Barelli A. ( 1995) Reactivation of oral lingual herpes by chlorinated swimming pool water: a case report [ see comments]. Cutis 56 ( 1): 49  50. Page 20 of 22 Detweiler M. B. and Barelli A. ( 1997) Reactivation of oral lingual herpes by chlorinated swimming pool water. A case report [ letter; comment]. Cutis 59 ( 5): 260.

Drobnic F., Freixa A., Casan P., Sanchis J., and Guardino X. ( 1996) Assessment of chlorine exposure in swimmers during training. Medicine and Science in Sports and Exercise 28 ( 2): 271  274.

Escartin J. L., Arnedo A., Pinto V., and Vela M. J. ( 2000) A study of dental staining among competitive swimmers. Community Dentistry and Oral Epidemiology 28 ( 1): 10  17. Exner Freisfeld H et al;. 1986. Dtsch Med Wochenschr 111 ( 50): 1927 30 Fisher A. A. ( 1987) Contact dermatitis to diving equipment, swimming pool chemicals, and other aquatic denizens. Clinics in Dermatology 5 ( 3): 36  40.

Gabai Y., Fattal B., Rahamin E., and Gedalia I. ( 1988) Effect of pH levels in swimming pools on enamel of human teeth. American Journal of Dentistry 1 ( 6): 241  243.

Haag J. R. and Gieser R. G. ( 1983) Effects of swimming pool water on the cornea. Journal of the American Medical Association ( 18): 2507  2508.

Helenius I. J., Rytila P., Metso T., Haahtela T., Venge P., and Tikkanen H. O. ( 1998) Respiratory symptoms, bronchial responsiveness, and cellular characteristics of induced sputum in elite swimmers. Allergy 53 ( 4): 346  352.

Hery et. al. ( 1995) Exposure to Chloramines in the Atmosphere or Indoor Swimming Pools pp. 427 439 Leung A. ( 1985) Erythema multiforme following swimming in a chlorinated pool [ letter]. Journal of the National Medical Association 77 ( 1): 13.

Michael, G. E.; Miday, R. K.; Bercz, J. P.; Miller, R. G.; Greathouse, D. G.; Kraemer, D. F.; and Lucas, J. B. 1981. Chlorine dioxide water disinfection: a prospective epidemiology study. Archives of Environmental Health. 36( 1): 20 27.

Momas I., Brette F., Spinasse A., Squinazi F., Dab W., and Festy B. ( 1993) Health effects of attending a public swimming pool: follow up of a cohort of pupils in Paris. Journal of Epidemiology and Community Health ( 6): 464  468.

Morgan D. W. and Shenoi P. M. ( 1989) Swimming in chlorinated water and its effect on eustachian tube function. Journal of Laryngology and Otology 103 ( 3): 257  258.

Mustchin C. P. and Pickering C. A. ( 1979) " Coughing Water": bronchial hyper reactivity induced by swimming in a chlorinated pool. Thorax 34 ( 5): 682  683. Page 21 of 22 National Research Council. ( NRC) 1981. Drinking Water & Health, Volume 4. Washington, DC: National Academy , p. 174 Neering H. ( 1977) Contact urticaria from chlorinated swimming pool water. Contact Dermatitis 3 ( 5): 279.

Ng S. K. and Goh C. L. ( 1989) Contact allergy to sodium hypochlorite in Eusol. Contact Dermatitis ( 4): 281.

Nieuwenhijsen and Chu, UK Team finds chloroform in indoor swimming pool. Health News. http:// www. billingsclinic. com/ health Ong S. J. and Kearney B. ( 1994) Local swimming pool and G 6 PD deficiency [ letter]. Medical Journal of Australia 161 ( 3): 226  227.

Penny P. T. ( 1983) Swimming pool wheezing. British Medical Journal 287 ( 6390): 461  462. Potts J. ( 1996) Factors associated with respiratory problems in swimmers. Sports Medicine 21 ( 4): 256  261.

Prindle, R. A. ( 1983) Leads from the MMWR: erosion of dental enamel among competitive swimmers Virginia. Journal of the American Medical Association ( 6): 716.

Robeck ( 1981) Chlorine, is there a better alternative. The Science of the Total Environment. 235 243.

Rose K. J. and Carey C. M. ( 1995) Intensive swimming: can it affect your patients' smiles? Journal of the American Dental Association 126 ( 10): 1402  1406.

Rothery S. P. ( 1991) Hazards of chlorine to asthmatic patients [ letter]. British Journal of General Practice 41 ( 342): 39.

Rylander R., Victorin K., and Sorensen S. ( 1973) The effect of saline on the eye irritation caused by swimming pool water. Journal of Hygiene 71 ( 3): 587  592.

Sasseville D., Geoffrion G., and Lowry R. N. ( 1999) Allergic contact dermatitis from chlorinated swimming pool water. Contact Dermatitis 41 ( 6): 347  348.

Small M. and Murray J. A. ( 1987) Nasal changes following immersion in chlorinated water. Rhinology 25 ( 3): 153  157.

The Merck Index  An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, O'Neil, M. J. ( ed.). Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 362 Page 22 of 22 Valsecchi R., Cassina G. P., and Migliori M. ( 1985) Tego dermatitis. Contact Dermatitis ( 4): 230.

Verhulst and Crolty ( 1971) Swimming Pool Disinfectants. Bulletin  National Clearinghouse for Poison Control Centers 3.

World Health Organization WHO ( 2000) Guidelines For Safe Recreational Water Environments. Volume 2: Swimming pools, spas and similar recreational water environments. http:// www. who. int/ water_ sanitation_ health/ Recreational_ water/ recreaII ch4. pdf.


[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66995-66999]
[FR Doc No: 2020-23290]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3771]

Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989; Draft Guidance for Industry; Availability; Agency Information
Collection Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Annual
Status Report Information and Other Submissions for Postmarketing
Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.''
Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and
Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and
Biologics, are intended to facilitate submissions by drug and
biological product application holders of complete and accurate
information on postmarketing requirements (PMRs) and postmarketing
commitments (PMCs) in a consistent format. Forms FDA 3988 and 3989 are
published in draft form in Appendix A and B of the draft guidance for
comment and are not intended to be used until the forms are finalized.
The forms were developed, in part, in response to the recommendations
from the Government Accountability Office (GAO) and the Department of
Health and Human Services (HHS) Office of the Inspector General (OIG)
regarding the need for comparable information across annual status
reports (ASRs) on PMRs and PMCs, to eliminate manual data entry, and to
enhance FDA's ability to track PMRs and PMCs. These forms are expected
to result in improved accuracy and timeliness of FDA's identification
and review of those submissions containing information on PMRs and
PMCs. This draft guidance covers the purpose of each form, when to use
these forms, and how to submit these forms. The draft guidance also
explains where applicants will be able to find the forms and
instructions for their completion once the forms and instructions are
finalized.

DATES: Submit either electronic or written comments on the draft
guidance by December 21, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the collection of information set forth in this document by December
21, 2020.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that

identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received should include the Docket
No. FDA-2018-N-3771 for ``Annual Status Report Information and Other
Submissions for Postmarketing Requirements and Commitments: Using Forms
FDA 3988 and FDA 3989.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989.'' This draft guidance is intended for applicants that are
required to report annually on the status of postmarketing studies and
clinical trials for human drug and biological products under section
506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
356b) and its implementing regulations at Sec. Sec.  314.81(b)(2)(vii)
and 601.70 (21 CFR 314.81(b)(2)(vii) and 601.70). These forms are
expected to result in improved accuracy and timeliness of FDA's
identification and review of those submissions containing information
on PMRs and PMCs. The purpose of the draft guidance is to explain why
Forms FDA 3988 and FDA 3989 were created, describe the contents of the
forms, and explain how to submit the forms electronically. The draft
guidance also explains where applicants will be able to find the forms
and instructions for their completion once the forms and instructions
are finalized. Forms FDA 3988 and 3989 are published in draft form in
Appendix A and B of the draft guidance for comment and are not intended
to be used until the forms are finalized.
    PMRs and PMCs are studies or clinical trials conducted by the
applicant after FDA has approved a drug or biological product for
marketing or licensing. These studies or clinical trials can be
required under statute or regulation (PMRs) or agreed upon in writing
by FDA and the applicant (PMCs). Section 130(a) of the Food and Drug
Administration Modernization Act of 1997 amended the FD&C Act by adding
section 506B of the FD&C Act (21 U.S.C. 356b). Under section 506B of
the FD&C Act and its implementing regulations at Sec. Sec.
314.81(b)(2)(vii) and 601.70, applicants must submit an ASR on PMRs and
PMCs.\1\ This report must address the progress of the PMR/PMC or the
reasons for failing to conduct the requirement or commitment (section
506B(a) of the FD&C Act).
---------------------------------------------------------------------------

    \1\ The FDA defines postmarketing studies or clinical trials for
which annual status reports (ASRs) must be submitted under section
506B of the FD&C Act as those concerning a human drug or biological
product's clinical safety, clinical efficacy, clinical pharmacology,
or nonclinical toxicology that are either required by FDA (PMRs) or
that are committed to, in writing, (PMCs) either at the time of
approval of an application or a supplement or after approval of an
application or supplement. See Sec. Sec.  314.81(b)(2)(vii) and
601.70. FDA interprets section 506B of the FD&C Act to apply to
postmarketing studies and clinical trials that are required under
the Pediatric Research Equity Act (section 505B of the FD&C Act (21
U.S.C. 355c); Sec. Sec.  314.55(b) and 601.27(b)), the animal
efficacy rule (Sec. Sec.  314.610(b)(1) and 601.91(b)(1)),
accelerated approval (section 506(c)(2)(A) of the FD&C Act;
Sec. Sec.  314.510 and 601.41), and the Food and Drug Administration
Amendments Act of 2007 (section 505(o)(3) of the FD&C Act (21 U.S.C.
355(o)(3)).
---------------------------------------------------------------------------

    This draft guidance does not apply to postmarketing studies or
clinical trials

that are not subject to the reporting requirements of section 506B of
the FD&C Act.\2\ For example, the draft guidance does not apply to
voluntary studies or clinical trials performed by an applicant or on an
applicant's behalf that are neither required nor agreed upon in
writing. This draft guidance also does not apply to PMCs related to
chemistry, manufacturing, and controls or stability studies.
---------------------------------------------------------------------------

    \2\ Under Sec.  314.81(b)(2)(viii), applicants submitting an
annual report for human drug products must include a status report
of postmarketing studies and clinical trials not included under
Sec.  314.81(b)(2)(vii) that are being performed by, or on behalf
of, the applicant.
---------------------------------------------------------------------------

    In a December 2015 report from the GAO entitled ``Drug Safety: FDA
Expedites Many Applications, but Data for Postapproval Oversight Need
Improvement,'' \3\ the GAO recommended that FDA improve its data
tracking to ensure the completeness, timeliness, and accuracy of
information in its database on PMRs/PMCs. Additionally, in a July 2016
HHS OIG study entitled ``FDA is Issuing More Postmarketing
Requirements, but Challenges with Oversight Persist,'' \4\ the HHS OIG
noted that FDA continued to have problems with its data management
system and work processes, thereby hindering its ability to track PMRs.
OIG recommended that FDA provide standardized forms for ASRs, ensure
that the forms are complete, and require applicants to submit the forms
electronically.
---------------------------------------------------------------------------

    \3\ Available at https://www.gao.gov/products/GAO-16-192.
    \4\ Available at https://oig.hhs.gov/oei/reports/oei-01-14-00390.asp.
---------------------------------------------------------------------------

    Based in part on the recommendations from GAO and HHS OIG, FDA
created Forms FDA 3988 and FDA 3989 to improve its collection,
identification, and use of information regarding PMRs and PMCs. Form
FDA 3988 was developed to accompany an applicant's PMR/PMC-related
submissions (e.g., draft protocols, final protocols, interim reports,
final reports, and PMR/PMC-related correspondence), except the ASR on
PMRs and PMCs. Form FDA 3988 allows applicants to identify, in a
standardized format, the type of PMR/PMC-related submission the
applicant is making (e.g., draft protocol) and the PMR or PMC to which
the submission applies. Form FDA 3989 was developed so that applicants
may provide ASR information on their PMRs and PMCs in a standardized
format. The purpose of these forms is to assist applicants in providing
clearly identified PMR/PMC-related submissions and in meeting their
annual reporting requirements under section 506B of the FD&C Act and
Sec. Sec.  314.81(b)(2)(vii) and 601.70.
    Use of Form FDA 3988 and 3989 is optional, but FDA encourages their
use because the forms should facilitate FDA management and review of
the applicant's submissions, as well as enhance the accuracy of data
within FDA's electronic document archiving systems. FDA uses these
archiving systems as a source from which to obtain data published
annually in the Federal Register as required under section 506B(c) of
the FD&C Act and to provide quarterly status updates of the PMR and PMC
data on FDA's Postmarket Requirements and Commitments public web page
(available at https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Annual
Status Report Information and Other Submissions for Postmarketing
Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989

    The draft guidance describes the purpose and content of Form FDA
3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and
Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics.
These forms are intended for applicants that are required by statute or
regulation, or that have agreed in writing, to conduct postmarketing
studies or clinical trials concerning the clinical safety, clinical
efficacy, clinical pharmacology, or nonclinical toxicology of a human
drug or biological product as PMRs or PMCs. Applicants are required to
submit ASRs on PMCs and PMRs under section 506B of the FD&C Act and its
implementing regulations at Sec. Sec.  314.81(b)(2)(vii) and 601.70,
and this information collection is approved under OMB control numbers
0910-0001 and 0910-0338, respectively. For this reason, these existing
control numbers will be updated to account for Forms FDA 3988 and FDA
3989.
    Form FDA 3988 would include the following information:
     Applicant's name, Center that approved or licensed the
application (Center for Drug Evaluation and Research or Center for
Biologics Evaluation and Research), application type (new drug
application (NDA), biologics license application (BLA), abbreviated new
drug application (ANDA), or investigational new drug application
(IND)), and submission date.
     Six-digit application number and supplement number(s) as
applicable.
     Drug or biologic product's established name (e.g., proper
name, U.S. Pharmacopeia/U.S. Adopted Name) and proprietary (trade)
name(s), if any.
     Information for all PMRs and PMCs addressed in the
submission, including type (PMR or PMC), PMR or PMC number,
establishment date, and National Clinical Trial (NCT) number (if
applicable).
     PMR/PMC submission type, including draft protocol, final
protocol, interim report, final report, general correspondence,
Pediatric Research

Equity Act PMR deferral extension request, response to information
request, request for revised milestones, and ``other,'' and a brief
description of the submission's content or rationale.
     Name and title of the applicant's Responsible Official,
and (as applicable) telephone and facsimile numbers, and email and
mailing addresses.
     Signature of the applicant's Responsible Official or other
Authorized Official, countersignature of the Authorized U.S. Agent, and
date that the form is signed.
    Form FDA 3989 would include the following information:
     Applicant's name, Center that approved or licensed the
application, application type, and submission date.
     Six-digit application number and date of U.S. approval.
     Drug or biologic product's established name (e.g., proper
name, U.S. Pharmacopeia/U.S. Adopted Name) and proprietary (trade)
name(s), if any.
     Alternate annual status report due date (i.e., a date
other than the approval date that FDA has allowed the applicant to use
for annual reporting).
     Period covered by the report.
     PMR/PMC update for each ``Open'' PMR/PMC. Information
includes PMR/PMC number, establishment date, supplement number as
applicable, description, study or clinical trial title as applicable,
current and expected enrollment of studies and clinical trials as
applicable, study or clinical trial status, explanation of status, and
milestone information (e.g., milestone type, original date, revised
date as applicable, the reason for the revision).
     Name and title of the applicant's Responsible Official,
and (as applicable) telephone and facsimile numbers, and email and
mailing addresses.
     Signature of the applicant's Responsible Official or other
Authorized Official, countersignature of the Authorized U.S. Agent, and
date that the form is signed.
    Forms FDA 3988 and FDA 3989 are fillable forms supporting
electronic signatures. Based on the number of applicants required by
statute or regulation, or that have agreed in writing, to conduct
postmarketing studies or clinical trials as PMRs or PMCs, and based on
the number of PMR/PMC-related submissions that we currently receive
annually, we estimate receiving approximately 1,908 Forms FDA 3988 and
636 Forms FDA 3989, annually, in accordance with the description in the
draft guidance. We estimate that approximately 318 \5\ applicants will
submit these forms, and that each form, as described in the draft
guidance, will take approximately 1 hour to prepare and electronically
submit to FDA.
---------------------------------------------------------------------------

    \5\ This number is based on information from ``The Food and Drug
Administration Report on the Performance of Drugs and Biologics
Firms in Conducting Postmarketing Requirements and Commitments.
Fiscal Year 2018'' available at https://www.fda.gov/media/129657/download.
---------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Reporting Burden \1\ \2\ \3\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
          Sec.   314.81              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Form FDA 3988...................             226               6           1,356               1           1,356
Form FDA 3989...................             226               2             452               1             452
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,808
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours for Form FDA 3989 in this table includes and replaces the burden that applicants currently incur
  to complete the ASR on PMRs and PMCs that is currently submitted as part of the annual report under Sec.
  314.81(b)(2).
\3\ Burden associated with OMB Control No. 0910-0001: Applications for FDA Approval to Market a New Drug.

                                 Table 2--Estimated Reporting Burden \1\ \2\ \3\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
          Sec.   601.70              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Form FDA 3988...................              92               6             552               1             552
Form FDA 3989...................              92               2             184               1             184
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             736
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours for Form FDA 3989 in this table includes and replaces the burden that applicants currently incur
  to complete the ASR on PMRs and PMCs that is currently submitted pursuant to Sec.   601.70.
\3\ Burden associated with OMB Control No. 0910-0338: General Licensing Provisions: Biologics License
  Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies
  Status Reports, and Form FDA 356h (21 CFR part 601).

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or
https://www.regulations.gov.

    Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23290 Filed 10-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49394-49395]
[FR Doc No: 2017-23149]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The date of March 6, 2018 has been established for the FIRM and,
where applicable, the supporting FIS report showing the new or modified
flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at www.msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: October 13, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.
    I. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Yavapai County, Arizona and Incorporated Areas
                         Docket No.: FEMA-B-1529
------------------------------------------------------------------------
City of Prescott.......................  Public Works Department, 201
                                          South Cortez Street, Prescott,
                                          AZ 86303.
Unincorporated Areas of Yavapai County.  Yavapai County Flood Control
                                          District Office, 1120 Commerce
                                          Drive, Prescott, AZ 86305.
------------------------------------------------------------------------
           Riverside County, California and Incorporated Areas
                         Docket No.: FEMA-B-1532
------------------------------------------------------------------------
City of Coachella......................  Community Development
                                          Department, 1515 Sixth Street,
                                          Coachella, CA 92236.
City of Indio..........................  Engineering Services Division,
                                          100 Civic Center Mall, Indio,
                                          CA 92201.
City of La Quinta......................  City Hall, Community
                                          Development Department, 78-495
                                          Calle Tampico, La Quinta, CA
                                          92253.
Unincorporated Areas of Riverside        Riverside County Flood Control
 County.                                  and Water Conservation
                                          District, 1995 Market Street,
                                          Riverside, CA 92501.
------------------------------------------------------------------------

[FR Doc. 2017-23149 Filed 10-24-17; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register: May 27, 2010 (Volume 75, Number 102)]
[Proposed Rules]
[Page 29699]
[DOCID:fr27my10-20]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2009-0612-200914(b); FRL-9155-4]

Approval and Promulgation of Air Quality Implementation Plans:
Florida; Approval of Section 110(a)(1) Maintenance Plan for the 1997 8-
Hour Ozone Standard for the Jacksonville, Tampa Bay, and Southeast
Florida Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to approve revisions to the Florida State
Implementation Plan (SIP) concerning the maintenance plans addressing
the 1997 8-hour ozone standards for the Jacksonville, Tampa Bay, and
Southeast Florida 1997 8-hour ozone attainment areas in Florida,
hereafter referred to as the ``Jacksonville Area,'' ``Tampa Bay Area,''
and ``Southeast Florida Area,'' respectively. The Jacksonville Area is
comprised of Duval County; the Tampa Bay Area comprises Hillsborough
and Pinellas Counties; and the Southeast Florida Area comprises
Broward, Dade, and Palm Beach Counties. These maintenance plans were
submitted to EPA on July 2, 2009, by the State of Florida, through the
Florida Department of Environmental Protection, and ensure the
continued attainment of the 1997 8-hour ozone national ambient air
quality standards (NAAQS) through the year 2014 in the Jacksonville,
Tampa Bay, and Southeast Florida Areas. EPA is proposing to approve the
SIP revisions pursuant to section 110 of the Clean Air Act. These
maintenance plans appear to meet all the statutory and regulatory
requirements, and are consistent with EPA's guidance. On March 12,
2008, EPA issued revised ozone standards. On September 16, 2009, EPA
announced it would reconsider the 2008 NAAQS for ozone and proposed a
new schedule for designations for a reconsidered standard. EPA
published a proposed rulemaking on January 19, 2010, for
reconsideration of the 2008 NAAQS, and expects to finalize the
reconsidered NAAQS by August 2010. The current proposed action,
however, is being taken to address requirements under the 1997 8-hour
ozone standards. Requirements for the Jacksonville, Tampa Bay, and
Southeast Florida Areas under the 2010 reconsidered ozone standards
will be addressed in the future.

DATES: Written comments must be received on or before June 28, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2009-0612, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2009-0612,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.
Please see the direct final rule which is located in the Rules section
of this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Twunjala Bradley, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Ms. Bradley can also be reached via electronic mail
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period on this document.
Any parties interested in commenting on this document should do so at
this time.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Incorporation by reference, Ozone, Nitrogen dioxides,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: May 11, 2010.
Beverly H. Banister,
Acting Regional Administrator, Region 4.
[FR Doc. 2010-12659 Filed 5-26-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Page 27339]
[FR Doc No: 2011-11516]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1971-DR; Docket ID FEMA-2011-0001]

Alabama; Amendment No. 8 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alabama (FEMA-1971-DR), dated April 28, 2011, and
related determinations.

DATES: Effective Date: May 4, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Alabama is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 28, 2011.

    Chambers County for Individual Assistance (already designated
for debris removal and emergency protective measures [Categories A
and B], including direct Federal assistance, under the Public
Assistance program).

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

    Dated: May 4, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-11516 Filed 5-10-11; 8:45 am]
BILLING CODE 9111-23-P