Preliminary Information September 14, 2004 1 Enclosure 1 Listing of Counties by State that EPA Recommended as Nonattainment, Were Identified to EPA as Nonattainment by the relevant State Entity and Showing where EPA Disagreed with the State Recommendation as of December 2003 EPA Region 1 CT, MA, ME, NH, RI, VT There are no EPA changes to state recommendations for these states. There are no Early Action Compacts in this region. There are 11 state recommended partial county nonattainment areas shown in the tables below. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Connecticut The following table identifies the areas within Connecticut that the state recommended and EPA intended to designate as nonattainment as of December 2003. The nonattainment designation covers the entire state.

Area Connecticut Recommended Nonattainment Counties EPA Recommended Nonattainment Counties New York City Metropolitan Area Connecticut Portion) Fairfield County Middlesex County New Haven County Fairfield County Middlesex County New Haven County Greater Connecticut Area Hartford County Litchfield County New London County Tolland County Windham County Hartford County Litchfield County New London County Tolland County Windham County Preliminary Information September 14, 2004 2 Maine The following table identifies the areas within Maine that the state recommended and EPA intended to designate as nonattainment as of December 2003. Where the state recommended only a part of a county and EPA intended to include only part of a county in a nonattainment area, we have indicated the boundaries of the portion of the county that will be included.

Area Maine Recommended Nonattainment Cities and Towns EPA Recommended Nonattainment Cities and Towns Southwest Maine Coast Area York County ( includes only the following cities and towns): Alfred, Arundel, Berwick, Biddeford, Buxton, Dayton, Elliot, Hollis, Kennebunk, Kennebunkport, Kittery, Limington, Lyman, North Berwick, Ogunquit, Old Orchard Beach, Saco, Sanford, South Berwick, Wells, and York Cumberland County ( includes only the following cities and towns): Brunswick, Cape Elizabeth, Casco, Cumberland, Falmouth, Freeport, Frye Island, Gorham, Gray, Harpswell, Long Island, New Gloucester, North Yarmouth, Portland, Pownal, Raymond, Scarborough, South Portland, Standish, Westbrook, Windham, and Yarmouth Sagadahoc County ( includes all cities and towns)

Androscoggin County ( includes only the following town): Durham York County ( includes only the following cities and towns): Alfred, Arundel, Berwick, Biddeford, Buxton, Dayton, Elliot, Hollis, Kennebunk, Kennebunkport, Kittery, Limington, Lyman, North Berwick, Ogunquit, Old Orchard Beach, Saco, Sanford, South Berwick, Wells, and York Cumberland County ( includes only the following cities and towns): Brunswick, Cape Elizabeth, Casco, Cumberland, Falmouth, Freeport, Frye Island, Gorham, Gray, Harpswell, Long Island, New Gloucester, North Yarmouth, Portland, Pownal, Raymond, Scarborough, South Portland, Standish, Westbrook, Windham, and Yarmouth Sagadahoc County ( includes all cities and towns)

Androscoggin County ( includes only the following town): Durham Preliminary Information September 14, 2004 3 Area Maine Recommended Nonattainment Cities and Towns EPA Recommended Nonattainment Cities and Towns Central Maine Coast Area Hancock County ( includes only the following cities and towns): Bar Harbor, Blue Hill, Brooklin, Brooksville, Cranberry Isles, Deer Isle, Frenchboro, Gouldsboro, Hancock, Lamoine, Mount Desert, Sedgwick, Sorrento, Southwest Harbor, Stonington, Sullivan, Surry, Swans Island, Tremont, Trenton, and Winter Harbor Waldo County ( includes only the following town): Islesboro Knox County ( includes only the following cities and towns): Camden, Criehaven, Cushing, Friendship, Isle au Haut, Matinicus Isle, Muscle Ridge Shoals, North Haven, Owls Head, Rockland, Rockport, St. George, South Thomaston, Thomaston, Vinalhaven, and Warren Lincoln County ( includes only the following cities and towns): Alna, Boothbay, Boothbay Harbor, Breman, Bristol, Damariscotta, Dresden, Edgecomb, Monhegan, Newcastle, Nobleboro, South Bristol, Southport, Waldoboro, Westport, and Wiscasset Hancock County ( includes only the following cities and towns): Bar Harbor, Blue Hill, Brooklin, Brooksville, Cranberry Isles, Deer Isle, Frenchboro, Gouldsboro, Hancock, Lamoine, Mount Desert, Sedgwick, Sorrento, Southwest Harbor, Stonington, Sullivan, Surry, Swans Island, Tremont, Trenton, and Winter Harbor Waldo County ( includes only the following town): Islesboro Knox County ( includes only the following cities and towns): Camden, Criehaven, Cushing, Friendship, Isle au Haut, Matinicus Isle, Muscle Ridge Shoals, North Haven, Owls Head, Rockland, Rockport, St. George, South Thomaston, Thomaston, Vinalhaven, and Warren Lincoln County ( includes only the following cities and towns): Alna, Boothbay, Boothbay Harbor, Breman, Bristol, Damariscotta, Dresden, Edgecomb, Monhegan, Newcastle, Nobleboro, South Bristol, Southport, Waldoboro, Westport, and Wiscasset Massachusetts Preliminary Information September 14, 2004 4 The following table identifies the counties within Massachusetts that the Commonwealth recommended and EPA intended to designate as nonattainment as of December 2003. The nonattainment designation covers the entire state.

Area Massachusetts Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Eastern Massachusetts Area Barnstable County Bristol County Dukes County Essex County Middlesex County Nantucket County Norfolk County Plymouth County Suffolk County Worcester County Barnstable County Bristol County Dukes County Essex County Middlesex County Nantucket County Norfolk County Plymouth County Suffolk County Worcester County Western Massachusetts Area Berkshire County Franklin County Hamden County Hampshire County Berkshire County Franklin County Hamden County Hampshire County Preliminary Information September 14, 2004 5 New Hampshire The following table identifies the area within New Hampshire that the state recommended and EPA intended to designate as nonattainment as of December 2003. Where the state recommended only a part of a county and EPA intended to include only part of a county in a nonattainment area, we have indicated the boundaries of the portion of the county that will be included.

Area New Hampshire Recommended Nonattainment Cities and Towns EPA Recommended Nonattainment Cities and Towns Southern New Hampshire Area Hillsborough County ( includes only the following cities and towns): Amherst, Bedford, Brookline, Goffstown, Hollis, Hudson, Litchfield, Manchester, Merrimack, Milford, Nashua and Pelham Merrimack County ( includes only the following town): Hooksett Rockingham County ( includes only the following cities and towns): Atkinson, Auburn, Brentwood, Candia, Chester, Danville, Derry, East Kingston, Epping, Exeter, Fremont, Greenland, Hampstead, Hampton, Hampton Falls, Kensington, Kingston, Londonderry, New Castle, Newfields, Newington, Newmarket, Newton, North Hampton, Plaistow, Portsmouth, Raymond, Rye, Salem, Sandown, Seabrook, South Hampton, Stratham, and Windham Strafford County ( includes only the following cities and towns): Dover, Durham, Rochester, Rollinsford, and Somersworth Hillsborough County ( includes only the following cities and towns): Amherst, Bedford, Brookline, Goffstown, Hollis, Hudson, Litchfield, Manchester, Merrimack, Milford, Nashua and Pelham Merrimack County ( includes only the following town): Hooksett Rockingham County ( includes only the following cities and towns): Atkinson, Auburn, Brentwood, Candia, Chester, Danville, Derry, East Kingston, Epping, Exeter, Fremont, Greenland, Hampstead, Hampton, Hampton Falls, Kensington, Kingston, Londonderry, New Castle, Newfields, Newington, Newmarket, Newton, North Hampton, Plaistow, Portsmouth, Raymond, Rye, Salem, Sandown, Seabrook, South Hampton, Stratham, and Windham Strafford County ( includes only the following cities and towns): Dover, Durham, Rochester, Rollinsford, and Somersworth Preliminary Information September 14, 2004 6 Rhode Island The following table identifies the counties within Rhode Island that the state recommended and EPA intended to designate as nonattainment as of December 2003. The nonattainment designation covers the entire State.

Area Rhode Island Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Rhode Island Area Bristol County Kent County Newport County Providence County Washington County Bristol County Kent County Newport County Providence County Washington County Vermont Entire state is attainment Preliminary Information September 14, 2004 7 EPA Region 2 NY, NJ, VI, PR There are no Early Action Compacts or state recommended partial county nonattainment areas in this region. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

New York The following table identifies the areas within New York that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the state recommendation are shown in bold. Where the state recommended only a part of a county and EPA intended to include only part of a county in a nonattainment area, we have indicated the boundaries of the portion of the county that will be included.

Area New York Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Jamestown, NY Chautauqua Chautauqua Buffalo Niagara Falls, NY Erie, Niagara Erie, Niagara Rochester, NY Monroe, Orleans, Wayne, Genesee, Livingston, Ontario ( recommended as unclassifiable) Monroe, Orleans, Wayne, Genesee, Livingston, Ontario ( added to nonattainment area)

Syracuse, NY Recommended as attaining based on 2000 2002 data, preliminary data for 2003 in violation Onondaga, Oswego, Madison, Cayuga ( added as a nonattainment area based on violation in 2003 preliminary data)

Jefferson County, NY Jefferson Jefferson Preliminary Information September 14, 2004 8 Essex County, NY Whiteface Mountain above 4,000 foot elevation recommended as unclassifiable ( partial county) Whiteface Mountain in Essex County above 1,900 foot elevation ( based on violation in 2003 preliminary data)( partial county)

Albany Metropolitan Area, NY Recommended as attaining based on 2000 2002, preliminary data for 2003 in violation Albany, Saratoga, Rensselaer, Schnectady, Montgomery, Schoharie, Greene ( added as a nonattainment area based on violation in 2003 preliminary data)

New York City Metropolitan Area, New York's portion of the NY NJ CT PA area Manhattan, Bronx, Kings, Queens, Richmond, Westchester, Rockland, Nassau, Suffolk. Manhattan, Bronx, Kings, Queens, Richmond, Westchester, Rockland, Nassau, Suffolk; plus three counties Orange, Dutchess and Putnam ( recommended by NY as a separate nonattainment area)

Orange Putnam Dutchess Counties, NY Orange, Putnam, Dutchess Include in NYC nonattainment area. Preliminary Information September 14, 2004 9 New Jersey The following table identifies the areas within New Jersey that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the state recommendation are shown in bold. The nonattainment designation covers the entire state.

Area New Jersey Recommended Nonattainment Counties EPA Recommended Nonattainment Counties New York City Metropolitan  New Jersey's portion of NY NJ CT PA area Bergen, Sussex, Passaic, Essex, Hudson, Union, Morris, Warren, Hunterdon, Somerset, Middlesex, Monmouth Bergen, Sussex, Passaic, Essex, Hudson, Union, Morris, Warren, Hunterdon, Somerset, Middlesex, Monmouth, Ocean ( added to this nonattainment area instead of Philadelphia, PA area)

Philadelphia Metropolitan area  New Jersey portion of PA DE MD NJ area Mercer, Ocean, Burlington, Camden, Gloucester, Atlantic, Salem, Cumberland, Atlantic, Cape May Mercer, Burlington, Camden, Gloucester, Atlantic, Salem, Cumberland, Atlantic, Cape May Virgin Islands and Puerto Rico Entire areas are attainment Preliminary Information September 14, 2004 10 EPA Region 3 PA, WV, VA, DE, MD, DC There are three state recommended partial county nonattainment areas in this region shown in the tables below. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Delaware The following table identifies the counties within Delaware that the state recommended and EPA intended to designate as nonattainment as of December 2003. The nonattainment designation covers the entire state.

Area Delaware Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Philadelphia, DE MD NJ PA Kent County New Castle County Sussex County Kent County New Castle County Sussex County District of Columbia The following table identifies the area within the District of Columbia that the District recommended and EPA intended to designate as nonattainment as of December 2003. The nonattainment designation covers the entire District.

Area District of Columbia Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Washington, DC MD VA District of Columbia District of Columbia Preliminary Information September 14, 2004 11 Maryland The following table identifies the areas and counties within Maryland that the Commonwealth recommended and EPA intended to designate as nonattainment as of December 2003.

Area Maryland Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Baltimore, MD Anne Arundel County Baltimore City Baltimore County Carroll County Harford County Howard County Anne Arundel County Baltimore City Baltimore County Carroll County Harford County Howard County Hagerstown, MD Early Action Compact Area Washington County Washington County Baltimore, MD Kent County Queen Anne's County Kent County Queen Anne's County Philadelphia, DE MD NJ PA Cecil County Cecil County Washington, DC MD VA Calvert County Charles County Frederick County Montgomery County Prince George's County Calvert County Charles County Frederick County Montgomery County Prince George's County Preliminary Information September 14, 2004 12 Pennsylvania The following table identifies the counties that the Commonwealth recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the state recommendation are shown in bold.

Area Pennsylvania Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Adams York, PA Adams County York County Adams County York County Allentown Bethlehem, PA Carbon County Lehigh County Northampton County Carbon County Lehigh County Northampton County Altoona, PA Blair County Clearfield, PA Clearfield County Clearfield County Erie, PA Erie County Erie County Franklin, PA Franklin County Franklin County Greene, PA Greene County Greene County Harrisburg Lebanon Carlisle, PA Cumberland County Dauphin County Lebanon County Perry County Cumberland County Dauphin County Lebanon County Perry County Indiana, PA Indiana County Johnstown, PA Cambria County Cambria County Lancaster, PA Lancaster County Lancaster County Philadelphia, DE MD NJ PA Bucks County Chester County Delaware County Montgomery County Philadelphia County Bucks County Chester County Delaware County Montgomery County Philadelphia County Preliminary Information September 14, 2004 13 Pittsburgh, PA Allegheny County Armstrong County Beaver County Butler County Fayette County Washington County Westmoreland County Allegheny County Armstrong County Beaver County Butler County Fayette County Washington County Westmoreland County Reading, PA Berks County Berks County Scranton Wilkes Barre, PA Lackawanna County Luzerne County Wyoming County Lackawanna County Luzerne County Monroe County Wyoming County State College, PA Centre County Centre County Tioga, PA Tioga County Youngstown Warren Sharon, OH PA Mercer County Mercer County Williamsport, PA Lycoming County Preliminary Information September 14, 2004 14 Virginia The following table identifies the areas and counties within Virginia that the Commonwealth recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Virginia Recommended Nonattainment Cities and Counties EPA Recommended Nonattainment Cities and Counties Frederick County, VA Early Action Compact Area Frederick County City of Winchester Frederick County City of Winchester Fredericksburg, VA Caroline County Spotsylvania County Stafford County City of Fredericksburg Caroline County Spotsylvania County Stafford County City of Fredericksburg Norfolk Virginia Beach Newport News, VA James City County York County City of Chesapeake City of Hampton City of Newport News City of Norfolk City of Poquoson City of Portsmouth City of Suffolk City of Virginia Beach City of Williamsburg James City County York County City of Chesapeake City of Hampton City of Newport News City of Norfolk City of Poquoson City of Portsmouth City of Suffolk City of Virginia Beach City of Williamsburg Gloucester County Isle of Wight County ( added counties)

Richmond, VA Charles City County ( partial county) Chesterfield County Hanover County Henrico County City of Colonial Heights City of Hopewell City of Richmond Charles City County ( whole county) Chesterfield County Hanover County Henrico County City of Colonial Heights City of Hopewell City of Richmond City of Petersburg Prince George County ( added areas) Preliminary Information September 14, 2004 15 Roanoke, VA Early Action Compact Area Botetourt County Roanoke County City of Roanoke City of Salem Botetourt County Roanoke County City of Roanoke City of Salem Shenandoah National Park, VA Page County ( partial) Madison County ( partial) Page County ( partial) Madison County ( partial)

Washington, DC MD VA Alexandria City Arlington County Fairfax City Fairfax County Falls Church City Fauquier County Loudoun County Manassas City Manassas Park City Prince William County Alexandria City Arlington County Fairfax City Fairfax County Falls Church City Fauquier County Loudoun County Manassas City Manassas Park City Prince William County Preliminary Information September 14, 2004 16 West Virginia The following table identifies the counties within West Virginia that the state recommended and EPA intended to designate as nonattainment as of December 2003.

Area West Virginia Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Charleston, WV Kanawha County Putnam County Kanawha County Putnam County Huntington Ashland Ironton, KY OH WV Cabell County Wayne County Cabell County Wayne County Parkersburg Marietta, OH WV Wood County Wood County Steubenville Weirton, OH WV Brooke County Hancock County Brooke County Hancock County Wheeling, OH WV Marshall County Ohio County Marshall County Ohio County Berkeley & Jefferson, WV Berkeley County Jefferson County Berkeley County Jefferson County Preliminary Information September 14, 2004 17 EPA Region 4 KY, TN, MS, AL, GA, FL, SC, NC There are 27 state recommended partial county nonattainment areas in this region shown in the tables below. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Alabama This table identifies the counties within Alabama that the state recommended and EPA intended to designate as nonattainment as of December 2003.

Area Alabama Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Birmingham Jefferson Shelby Jefferson Shelby Florida Entire state is attainment Preliminary Information September 14, 2004 18 Georgia The following table identifies the counties within Georgia that the state recommended and EPA intended to designate as nonattainment as of December 2003. Where the state recommended only a part of a county and EPA intended to include only part of a county in a nonattainment area, we have indicated the boundaries of the portion of the county that will be included. EPA recommended nonattainment area that differ from the state recommendation are shown in bold.

Area Georgia Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Atlanta Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall, Henry, Newton, Paulding, Rockdale, Spalding and Walton Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall, Henry, Newton, Paulding, Rockdale, Spalding and Walton Chattanooga TNGA None Catoosa and Walker ( added counties)

Macon Bibb Bibb, Houston and Monroe ( added counties)

Murray County Murray County  all mountain peaks within the Chattahoochee National Forest area of Murray County that have an elevation greater than or equal to 2400 feet and that are enclosed by contour lines that close on themselves Murray County  all mountain peaks within the Chattahoochee National Forest area of Murray County that have an elevation greater than or equal to 2400 feet and that are enclosed by contour lines that close on themselves Preliminary Information September 14, 2004 19 Kentucky The following table identifies the counties within Kentucky that the Commonwealth recommended and EPA intended to designate as nonattainment as of December 2003.

Area Kentucky Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Bell County Bell Bell Warren County Warren Warren Cincinnati Hamilton, OH KY IN Boone Campbell Kenton Boone Campbell Kenton Clarkesville Hopkinsville, TN KY Christian Christian Huntington Ashland, KY WV Boyd Boyd Louisville, KY IN Bullitt Jefferson Oldham Bullitt Jefferson Oldham Mississippi The following table identifies the county within Mississippi that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the state recommendation are shown in bold.

Area Mississippi Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Memphis DeSoto ( separate) DeSoto ( included in the Memphis nonattainment area combined with other counties into one large nonattainment area) Preliminary Information September 14, 2004 20 North Carolina The following table identifies the areas and counties within North Carolina that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the state recommendation are shown in bold.

Area North Carolina Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Plott Balsam Mountains, NC Area above 4000 feet in Haywood Area above 4000 feet in Haywood.

Great Smoky Mountains National Park, NC Park area in Haywood, Swain Park area in Haywood, Swain Charlotte Gastonia Rock Hill, NC SC ( Early Action Compact Area) Gaston, Mecklenburg, Cabarrus except for the northeastern corner ( Rimertown, Gold Hill and Mount Pleasant Townships), Portion of Lincoln east of the South Fork of the Catawba River, Rowan County except the northwestern corner ( Cleveland, Mount Ulla, Scotch Irish, Steele, and Unity Townships), Portion of Union County covered by the MPO ( western portion of county), Portion of Iredell ( adjacent county) including Coddle Creek and Davidson Townships. Gaston, Mecklenburg, Cabarrus, Lincoln, Rowan, Union, and Iredell ( all included as full rather than partial counties)

Fayetteville, NC ( Early Action Compact Area) Cumberland Cumberland Greensboro Winston Salem High Point, NC ( Early Action Compact Area) Alamance, Davidson, Forsyth, Guilford, Jerusalem Township portion of Davie, Portion of Randolph north of Highway 64 and the Asheboro municipal boundary, Stoney Creek Township portion of Caswell ( adjacent), New Bethel Township portion of Rockingham ( adjacent) Alamance, Davidson, Forsyth, Guilford, Davie, Randolph, Caswell and Rockingham ( all included as full rather than partial counties); Stokes and Yadkin ( added counties) Preliminary Information September 14, 2004 21 Hickory Newton Conover, NC ( Early Action Compact Area) MPO portions of Burke, Caldwell, and Catawba and the municipality of Taylorsville in Alexander Burke, Caldwell, Catawba, and Alexander ( all included as full rather than partial counties)

Raleigh Durham Chapel Hill, NC Durham, Orange, Wake, eastern portion of Chatham ( Baldwin, Center, New Hope, and Williams Townships), southern portion of Franklin ( Franklinton and Youngsville Townships), western portion of Johnston ( west of I 95), Dutchville Township in Granville ( adjacent), Bushy Fork Township in Person ( adjacent) Durham, Orange, Wake, Chatham, Franklin, Johnston, Granville and Person ( all included as full rather than partial counties)

Rocky Mount, NC Municipality of Leggett portion of Edgecomb Edgecomb ( full county) and Nash ( added county) Preliminary Information September 14, 2004 22 South Carolina The following table identifies the areas and counties within South Carolina that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the state recommendation are shown in bold.

Area South Carolina Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Charlotte Gastonia Rock Hill NC SC1 ( Early Action Compact Area) None York ( added to the larger nonattainment area in NC)

Columbia ( Early Action Compact Area) Portion of Richland; Portion of Lexington Richland, Lexington ( both included as full rather than partial counties)

Greenville Spartanburg Anderson ( Early Action Compact Area) Portion of Anderson, based on MPO boundary, extended to encompass violating monitor; portion of Greenville based on MPO boundary; portion of Spartanburg, based on MPO boundary extended to encompass violating monitor; Anderson, Greenville, and Spartanburg ( all included as full rather than partial counties); Pickens, Cherokee ( added counties) Preliminary Information September 14, 2004 23 Tennessee The following table identifies the counties within Tennessee that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the state recommendation are shown in bold.

Area Tennessee Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Haywood County Haywood Haywood Putnam County Putnam Putnam Chattanooga TN GA ( Early Action Compact Area) Hamilton and Meigs Hamilton, Meigs and Marion ( added county)

Clarkesville Hopkinsville TN KY None Montgomery ( added to the nonattainment area)

Knoxville ( Early Action Compact Area) Blount, Knox, Loudon, Jefferson and Sevier Blount, Knox, Loudon, Jefferson, Sevier and Union ( added county)

Memphis TN AR MS ( Early Action Compact Area) Shelby Shelby, Fayette and Tipton ( added counties)

Nashville ( Early Action Compact Area) Davidson, Rutherford, Sumner, Williamson, and Wilson Davidson, Rutherford, Sumner, Williamson, Wilson, Cheatham, Dickson and Robertson ( added counties)

Johnson City Kingsport Bristol Area, TN ( Early Action Compact Area) Sullivan and Washington Sullivan, Washington, Hawkins and Unicoi ( added counties) Preliminary Information September 14, 2004 24 EPA Region 5 IL, IN, MI, MN, OH, WI There are no Early Action Compacts in this region. There are two state recommended partial county nonattainment areas shown in the tables below. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Illinois The following table identifies counties within Illinois that the state recommended and EPA intended to designate as nonattainment as of December 2003.

Area Illinois Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Chicago Gary Lake County, IL IN (*) Cook DuPage Kane Lake McHenry Will Grundy: Aux Sable Township Goose Lake Township Kendall: Oswego Township Cook DuPage Kane Lake McHenry Will Grundy: Aux Sable Township Goose Lake Township Kendall: Oswego Township St. Louis, MO IL Jersey Madison Monroe St. Clair Jersey Madison Monroe St. Clair * The ozone design value site for this area is the Chiwaukee Prairie monitoring site in Kenosha County, Wisconsin. Preliminary Information September 14, 2004 25 Indiana The following table identifies the counties within Indiana that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Indiana Recommended Nonattainment Counties EPA recommended Nonattainment Counties Chicago Gary Lake County IL IN (*) Lake Porter Lake Porter LaPorte IN LaPorte LaPorte South Bend/ Elkhart IN Elkhart St. Joseph Elkhart St. Joseph Louisville KY IN Clark Floyd Clark Floyd Fort Wayne IN Allen Allen Huntington ( added county)

Central Indiana Marion Boone Hendricks Morgan Johnson Shelby Hancock Madison Hamilton Marion Boone Hendricks Morgan Johnson Shelby Hancock Madison Hamilton Muncie IN Delaware Delaware Cincinnati OH KY IN None Dearborn ( added county)

Greene County IN County affected by Overwhelming Transport Greene ( added county)

Jackson County IN County affected by Overwhelming Transport Jackson ( added county)

Evansville IN KY None or only Warrick Warrick Vanderburgh ( added county) Preliminary Information September 14, 2004 26 Terre Haute IN Vigo Vigo * The ozone design value site for this area is the Chiwaukee Prairie monitoring site in Kenosha County, Wisconsin. Preliminary Information September 14, 2004 27 Michigan The following table identifies the counties within Michigan that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Michigan Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Benton Harbor Area  MI Berrien Berrien Benzie County Area  MI Benzie Benzie Cass County Area  MI Cass Cass Detroit Ann Arbor Area  MI Livingston Macomb Monroe Oakland St. Clair Washtenaw Wayne As a separate area: Genesee Lapeer As a separate area: Lenawee Livingston Macomb Monroe Oakland St. Clair Washtenaw Wayne Genesee Lapeer Lenawee ( combined with other counties as one nonattainment area)

Grand Rapids Muskegon Holland Area  MI As a separate area: Allegan As a separate area: Muskegon As a separate area: Ottawa Allegan Kent Muskegon Ottawa ( added Kent and combined as one nonattainment area)

Huron County Area  MI None Huron ( added county)

Kalamazoo Battle Creek Area  MI None Calhoun Kalamazoo Van Buren ( added counties) Preliminary Information September 14, 2004 28 Lansing East Lansing Area  MI None Clinton Eaton Ingham ( added counties)

Mason County Area  MI Mason Mason Preliminary Information September 14, 2004 29 Ohio The following table identifies the counties within Ohio that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Ohio Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Canton Massillion, OH Stark Stark Cincinnati Hamilton, OH KY IN Butler Clermont Clinton Hamilton Warren Butler Clermont Clinton Hamilton Warren Cleveland Akron, OH Ashtabula Cuyahoga Geauga Lake Lorain Medina As a separate area: Portage Summit Ashtabula Cuyahoga Geauga Lake Lorain Medina Portage Summit ( combined with other counties as one nonattainment area)

Columbus, OH Delaware Fairfield Franklin Licking Madison As a separate area: Knox Delaware Fairfield Franklin Licking Madison Knox ( combined with other counties as one nonattainment area)

Dayton Springfield, OH Clark Greene Miami Montgomery Clark Greene Miami Montgomery Preliminary Information September 14, 2004 30 Huntington Ashland, WV KY OH Lawrence Lawrence Lima, OH Allen Allen Parkersburg Marietta, WV OH Washington Washington Steubenville Weirton, OH WV Jefferson Jefferson Toledo, OH Lucas Wood Lucas Wood Youngstown Warren Sharon, PA OH As a separate area from Mercer, PA: Mahoning Trumbull As a separate area: Columbiana Mahoning Trumbull Columbiana ( combined all three counties as one nonattainment area)

Wheeling, WV OH no counties recommended Belmont ( added county) Preliminary Information September 14, 2004 31 Wisconsin The following table identifies the counties within Wisconsin that the state recommended and EPA intended to designate as nonattainment as of December 2003.

Area Wisconsin Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Door County Area, WI Door Door Jefferson County Area, WI Jefferson Kewaunee County Area, WI Kewaunee Kewaunee Manitowoc County Area, WI Manitowoc Manitowoc Milwaukee Racine Area, WI Kenosha Milwaukee Ozaukee Racine Washington Waukesha Kenosha Milwaukee Ozaukee Racine Washington Waukesha Sheboygan Area, WI Sheboygan Sheboygan Minnesota Entire state is attainment Preliminary Information September 14, 2004 32 EPA Region 6 NM, TX, OK, AR, LA There are no state recommended partial county nonattainment areas in this region. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Arkansas The following table identifies the counties comprising within Arkansas that the state recommended and EPA intended to designate as nonattainment as of December 2003.

Area Arkansas Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Memphis Area ( Early Action Compact Area) Crittenden Crittenden Little Rock Area  The area would be attainment if the State submits 2001 2003 data showing that the Little Rock CMSA is below the standard.

The State of Arkansas' recommendation was made to designate Faulkner, Lonoke, Pulaski and Saline Counties within the Little Rock MSA as nonattainment based on 2000 2002 monitoring data. Preliminary 2001 2003 ozone monitoring data indicate that the Little Rock Metropolitan Statistical Area ( MSA) is not currently violating the 8 hour standard. However, there is concern that through the remainder of the calendar year or through the quality assurance process of the monitoring data, the Little Rock MSA may show a violation. If this situation were to occur, we would consider the entire Little Rock MSA as nonattainment. It is important for Arkansas to expedite submittal of final quality assured 2003 monitoring data by December 1, 2003, in order to accurately reflect the air quality in this area. Preliminary Information September 14, 2004 33 Louisiana The following table identifies the counties within Louisiana that the state recommended and EPA intended to designate as nonattainment as of December 2003.

Area Louisiana Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Baton Rouge Ascension, East Baton Rouge, Iberville, Livingston and West Baton Rouge Ascension, East Baton Rouge, Iberville, Livingston and West Baton Rouge New Mexico Entire state is attainment Oklahoma Tulsa Area ( Early Action Compact Area)  The entire state would be attainment if the State submits 2001 2003 data showing that the Tulsa CMSA is below the standard.

The State's recommendation was to designate the Tulsa Transportation Management Area within the Tulsa Metropolitan Statistical Area ( MSA) as unclassifiable based on 2000 2002 ozone monitoring data. Preliminary 2001 2003 ozone monitoring data indicate that the Tulsa MSA is not currently violating the 8 hour standard. However, there is concern that through the remainder of the calendar year or through the quality assurance process of the monitoring data, the area may show a violation. If this situation were to occur, we would consider the entire Tulsa MSA as nonattainment because it is the presumptive nonattainment area. It is important for Oklahoma to expedite submittal of final quality assured 2003 monitoring data by December 1, 2003, in order to accurately reflect the air quality in this area. Preliminary Information September 14, 2004 34 Texas The following table identifies the individual counties within Texas that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Texas Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Beaumont/ Port Arthur area Hardin, Jefferson and Orange Hardin, Jefferson and Orange Dallas Fort Worth area Collin, Dallas, Denton, Ellis, Johnson, Parker and Tarrant Collin, Dallas, Denton, Ellis, Henderson, Hood, Hunt, Johnson, Kaufman, Parker, Rockwall and Tarrant ( added counties)

Houston Galveston Brazoria area Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery and Waller Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery and Waller San Antonio area ( Early Action Compact Area) Bexar Bexar, Comal, Guadalupe, Wilson ( added counties)

Longview Marshall Area  The area would be attainment if the State submits 2001 2003 data showing that the Longview Marshall CMSA is below the standard.

The State's recommendation was to designate Gregg County within the Longview Marshall Metropolitan Statistical Area ( MSA) as nonattainment based on 2000 2002 monitoring data. Preliminary 2001 2003 ozone monitoring data indicate that the Longview Marshall MSA may not be violating the 8 hour standard. While preliminary 2001 2003 ozone data indicate there are currently no monitors in the Longview Marshall MSA violating the 8 hr standard, there is concern that through the remainder of the calendar year or through the quality assurance process of the monitoring data, the area may show a violation. If this situation were to occur, we would consider the entire Longview Marshall MSA as nonattainment because this area is the presumptive nonattainment area. It is important for Texas to expedite submittal of final qualityassured 2003 monitoring data by December 1, 2003, in order to accurately reflect the air quality in this area. Preliminary Information September 14, 2004 35 Austin San Marcos Area  ( Early Action Compact Area)  The area would be attainment if the State submits 2001 2003 data showing that the Austin San Marcos CMSA is below the standard.

The State's recommendation was to designate Travis County within the Austin San Marcos MSA as nonattainment based on 2000 2002 monitoring data. Preliminary 2001 2003 ozone monitoring data indicate that the Austin San Marcos MSA may not be violating the 8 hour standard. While preliminary 2001 2003 ozone data indicate there are currently no monitors in the Austin San Marcos MSA violating the 8 hr standard, there is concern that through the remainder of the calendar year or through the quality assurance process of the monitoring data, the area may show a violation. If this situation were to occur, we would consider the entire Austin San Marcos MSA as nonattainment because this area is the presumptive nonattainment area. It is important for Texas to expedite submittal of final quality assured 2003 monitoring data by December 1, 2003, in order to accurately reflect the air quality in this area. Preliminary Information September 14, 2004 36 EPA Region 7 NE, KS, IA, MO There are no Early Action Compacts in this region. There is one state recommended partial county nonattainment areas shown in the tables below. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Kansas The following table identifies the counties within Kansas that the state recommended and EPA intended to designate as nonattainment areas as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Kansas Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Kansas City, MO KS Johnson and Wyandotte Counties Johnson, Linn, Miami, Wyandotte Counties ( added counties)

Missouri The following table identifies the counties within Missouri that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Missouri Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Kansas City, MO KS Cass ( partial county), Clay, Jackson, and Platte Counties Cass ( whole county), Clay, Jackson, and Platte Counties St. Louis, MO IL St. Charles, St. Louis, Franklin, and Jefferson Counties and St. Louis City St. Charles, St. Genevieve, St. Louis, Franklin, and Jefferson Counties and St. Louis City ( added county)

Nebraska and Iowa Entire states are attainment Preliminary Information September 14, 2004 37 EPA Region 8 UT, CO, WY, MT, ND, SD There are no state recommended partial county nonattainment areas in this region. The information in the tables below reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Colorado The following table identifies counties within Colorado that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Colorado Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Denver Metropolitan Area Recommended as attaining based on 2000 2002 data, preliminary data for 2003 in violation Adams, Arapahoe, Boulder, Broomfield, Denver, Douglas, Elbert, Jefferson, Larimer, Morgan, and Weld ( added as a nonattainment area based on violation in 2003 preliminary data)

Utah, Wyoming, Montana, North Dakota, South Dakota Entire states are attainment Preliminary Information September 14, 2004 38 EPA Region 9 AZ, CA, NV, HI There are no Early Action Compacts in this region. There are eight state recommended partial county nonattainment areas shown in the tables below. The information in the tables reflects EPA recommendations as of December 2003. EPA intended to designate as unclassifiable/ attainment all counties or parts thereof not identified in the tables.

Arizona The following table identifies counties within Arizona that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area Arizona Recommended Nonattainment Counties EPA Recommended Nonattainment Counties Phoenix Area Maricopa County ( excluding far western and southwestern portions) Maricopa County ( excluding far western and southwestern portions), Area A portion of northern Pinal County added Preliminary Information September 14, 2004 39 California The following table identifies counties within California that the state recommended and EPA intended to designate as nonattainment as of December 2003. EPA recommended nonattainment areas that differ from the recommendation are shown in bold.

Area California Recommended Nonattainment Counties EPA Recommended Nonattainment Counties South Coast Air Basin Los Angeles ( South Coast Air Basin portion which includes Santa Catalina and San Clemente Islands), Orange, San Bernardino ( South Coast Air Basin portion), Riverside ( South Coast Air Basin portion) Los Angeles ( South Coast Air Basin portion which includes Santa Catalina and San Clemente Islands), Orange, San Bernardino ( South Coast Air Basin portion), Riverside ( South Coast Air Basin portion)

San Joaquin Valley San Joaquin, Stanislaus, Merced, Madera, Fresno, Kings, Tulare, Kern ( San Joaquin Air Basin portion) San Joaquin, Stanislaus, Merced, Madera, Fresno, Kings, Tulare, Kern ( San Joaquin Air Basin portion), Amador, Calaveras, Tuolomne, Mariposa ( added to the other counties proposed as separate areas by the state )

Sacramento Region Sacramento, Yolo, Solano ( Sacramento Valley Air Basin portion), El Dorado ( Sacramento Valley Air Basin portion), Placer ( Sacramento Valley Air Basin portion) Sacramento, Yolo, Solano ( Sacramento Valley Air Basin portion), El Dorado ( Sacramento Valley Air Basin portion), Placer ( Sacramento Valley Air Basin portion), Nevada ( Sacramento Valley Air Basin portion) ( added to the other counties proposed as a separate area by the state)

Western Mojave Desert San Bernardino ( Mojave Desert Air Basin portion) San Bernardino ( Mojave Desert Air Basin portion), Los Angeles ( Antelope Valley portion aka Mojave Desert Air Basin portion) ( added partial county)

Coachella Valley Riverside ( Salton Sea Air Basin portion) Riverside ( Salton Sea Air Basin portion) Preliminary Information September 14, 2004 40 Ventura County Ventura Ventura Eastern Kern County Kern ( Eastern Kern aka Mojave Desert Air Basin portion) Kern ( Eastern Kern aka Mojave Desert Air Basin portion)

San Diego County San Diego San Diego Antelope Valley Los Angeles ( Antelope Valley portion aka Mojave Desert Air Basin portion) ( See Western Mojave Desert)

Imperial County Imperial Imperial Western Nevada County Nevada ( Sacramento Valley Air Basin portion) ( See Sacramento Region)

Central Mountain Counties Amador, Calaveras ( See San Joaquin Valley)

Southern Mountain Counties Tuolumne, Mariposa ( See San Joaquin Valley)

Butte County Butte Butte San Francisco Bay Area Not recommended based on attaining 2000 2002 data; 2003 in violation San Francisco, Marin, southern Sonoma ( San Francisco Bay Air Basin portion), Napa, western Solano ( San Francisco Bay Air Basin portion), Contra Costa, Alameda, Santa Clara, San Mateo ( added as a nonattainment area based on violation in 2003 data)

Yuba City Not recommended based on attaining 2000 2003 data; 2003 in violation Sutter, Yuba ( added as a nonattainment area based on 2003 data)

Nevada Entire state is attainment While there currently appears to be no areas violating the 8 hour ozone standard, we understand that Clark County and the associated MSA are close to violating. We will be following the monitoring of this area closely for 2003 and the foreseeable future, as 2003 appears to have been higher than several previous years, and as such will continue to affect the 3 year average design Preliminary Information September 14, 2004 41 value for the area for several years.

Hawaii Entire state is attainment Preliminary Information September 14, 2004 42 EPA Region 10 WA, OR, ID, AK Washington, Oregon, Idaho, Alaska Entire states are attainment


[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Notices]
[Pages 28016-28018]
[FR Doc No: 2022-10030]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0168]

Benefit-Risk Considerations for Product Quality Assessments;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Benefit-
Risk Considerations for Product Quality Assessments.'' This guidance
describes the benefit-risk principles applied by FDA when conducting
product quality-related assessments of chemistry, manufacturing, and
controls (CMC) information submitted for FDA assessment as part of
original new drug applications (NDAs), original biologics license
applications (BLAs), or supplements to such applications, in addition
to other information (e.g., inspectional findings) available to FDA
during its assessment. This guidance discusses how FDA assesses risks,
sources of uncertainty, and possible mitigation strategies for a
product quality-related issue and how those considerations inform FDA's
understanding of the potential effect on a product. This guidance also
discusses how unresolved product quality issues may be addressed in the
context of regulatory decision making. The guidance notes that product
quality assessments are also done for abbreviated new drug applications
(ANDAs), and it discusses how, in certain rare circumstances,
unresolved product quality issues may be addressed when there is an
urgent clinical need for

an ANDA (e.g., a public health emergency or a pervasive drug shortage).

DATES: Submit either electronic or written comments on the draft
guidance by July 11, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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 must include the Docket No.
FDA-2022-D-0168 for ``Benefit-Risk Considerations for Product Quality
Assessments.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    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. 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: Natalia Comella, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 301-
796-6226.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Benefit-Risk Considerations for Product Quality
Assessments.'' This guidance describes the benefit-risk principles
applied by FDA when conducting product quality-related assessments of
CMC information submitted for FDA assessment as part of original NDAs
under section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), original BLAs under section 351 of the Public Health
Service Act (42 U.S.C. 262), or supplements to such applications, in
addition to other information (e.g., inspectional findings) available
to FDA during its assessment. This guidance discusses how FDA assesses
risks, sources of uncertainty, and possible mitigation strategies for a
product quality-related issue and how those considerations inform FDA's
understanding of the potential effect on a product. The outcome of the
product quality assessment results in a determination as to whether an
applicant has developed a drug product, manufacturing process, and
control strategy that will consistently result in a product of
acceptable quality when manufactured at the facilities named in the
application.
    When a regulatory decision regarding the approval of an NDA or BLA
is made, FDA considers the overall benefit(s) and risks identified for
the product. This can include any residual risk related to unresolved
product quality issues if they directly affect the assessment. This
guidance also discusses how unresolved product quality issues may be
addressed in the context of regulatory decision making. The guidance
notes that product quality assessments are also done for ANDAs, and it
discusses how, in certain rare circumstances, unresolved product
quality issues may be addressed when there is an urgent clinical need
for an ANDA (e.g., a public health emergency or a pervasive drug
shortage).
    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 ``Benefit-Risk
Considerations for Product Quality Assessments.'' 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR parts 601 and 610 have been
approved under OMB control number 0910-0338.

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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10030 Filed 5-9-22; 8:45 am]
BILLING CODE 4164-01-P