United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng PLAW Bills and Statutes An act to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes.;Food and Drug Administration Modernization Act of 1997;Public Law 105-115; 105_cong_public_laws legislative 2010-08-11 S. 830, 105th Congress S. 830, 105th Congress H.R. 1411, 105th Congress U.S. Government Printing Office 1997-11-21 monographic deposited born digital 86 digital object pages AE 2.110: AE 2.110/3: AE 2.110:105-115 https://www.govinfo.gov/app/details/PLAW-105publ115 P0b002ee180360bdc 000524864 f:publ115.105 DGPO 2010-08-11 2026-01-04 PLAW-105publ115 machine generated eng fdlp PUBLIC PLAW-105publ115 105 115 Food and Drug Administration Modernization Act of 1997 false LEGISLATIVE HISTORY--S. 830 (H.R. 1411):<br/><br/><br/>HOUSE REPORTS: Nos. 105-310, accompanying H.R. 1411 (Comm. on Commerce) <br/>and 105-399 (Comm. of Conference).<br/>SENATE REPORTS: No. 105-43 (Comm. on Labor and Human Resources).<br/>CONGRESSIONAL RECORD, Vol. 143 (1997):<br/> Sept. 11, 16, 18, 19, 23, 24, considered and passed Senate.<br/> Oct. 7, considered and passed House, amended, in lieu of <br/> H.R. 1411.<br/> Nov. 9, Senate and House agreed to conference report.<br/>WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 33 (1997):<br/> Nov. 21, Presidential remarks.<br/><br/> Committee on Commerce Commerce Committee on Labor and Human Resources Labor and Human Resources

U.S. Government Printing Office 1997-11-21 monographic deposited born digital 86 p. AE 2.110: AE 2.110/3: AE 2.110:105-115 P0b002ee180360bdc https://www.govinfo.gov/app/details/PLAW-105publ115 f:publ115.105 Public Law 105-115 https://www.govinfo.gov/app/details/PLAW-105publ115 https://www.govinfo.gov/content/pkg/PLAW-105publ115/html/PLAW-105publ115.htm https://www.govinfo.gov/content/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf fdlp DGPO 2010-08-11 2026-01-04 PLAW-105publ115 machine generated eng PUBLIC PLAW-105publ115 105 115 Food and Drug Administration Modernization Act of 1997 false LEGISLATIVE HISTORY--S. 830 (H.R. 1411):<br/><br/><br/>HOUSE REPORTS: Nos. 105-310, accompanying H.R. 1411 (Comm. on Commerce) <br/>and 105-399 (Comm. of Conference).<br/>SENATE REPORTS: No. 105-43 (Comm. on Labor and Human Resources).<br/>CONGRESSIONAL RECORD, Vol. 143 (1997):<br/> Sept. 11, 16, 18, 19, 23, 24, considered and passed Senate.<br/> Oct. 7, considered and passed House, amended, in lieu of <br/> H.R. 1411.<br/> Nov. 9, Senate and House agreed to conference report.<br/>WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 33 (1997):<br/> Nov. 21, Presidential remarks.<br/><br/> Committee on Commerce Commerce Committee on Labor and Human Resources Labor and Human Resources

S. 830 105 side note S. 830 105 legislative history H.R. 1411 105 legislative history Title 5 Section 552 Title 5 Section 5703 5 U.S.C. 552 5 U.S.C. 5703 Title 15 Section 1451 Title 15 Section 1451et seq. Title 15 Section 1471 Title 15 Section 1471et seq. 15 U.S.C. 1451 15 U.S.C. 1451et seq. 15 U.S.C. 1471 15 U.S.C. 1471et seq. Title 21 Section 301et seq. Title 21 Section 321 Title 21 Section 321(aa) Title 21 Section 321(dd) Title 21 Section 321(ff)(3)(A) Title 21 Section 331 Title 21 Section 331(e) Title 21 Section 331(i)(1) Title 21 Section 331(j) Title 21 Section 334(d)(1) Title 21 Section 335a(d)(4)(B)(ii) Title 21 Section 341et seq. Title 21 Section 343(r) Title 21 Section 343(r)(2) Title 21 Section 343(r)(2)(B) Title 21 Section 343(r)(3) Title 21 Section 343(r)(4)(A)(i) Title 21 Section 348 Title 21 Section 348(a) Title 21 Section 351(a) Title 21 Section 351(a)(2)(C) Title 21 Section 351(e) Title 21 Section 351et seq. Title 21 Section 352 Title 21 Section 352(a) Title 21 Section 352(d) Title 21 Section 352(e)(1) Title 21 Section 353 Title 21 Section 353(b)(1) Title 21 Section 353(b)(3) Title 21 Section 353(b)(4) Title 21 Section 353(g)(4) Title 21 Section 355 Title 21 Section 355(b) Title 21 Section 355(b)(1) Title 21 Section 355(c) Title 21 Section 355(d) Title 21 Section 355(i) Title 21 Section 355(j) Title 21 Section 356 Title 21 Section 357 Title 21 Section 360aa(a) Title 21 Section 360bb Title 21 Section 360bb(b) Title 21 Section 360b(c) Title 21 Section 360cc(a) Title 21 Section 360cc(b) Title 21 Section 360c(a)(3) Title 21 Section 360c(a)(3)(A) Title 21 Section 360c(b) Title 21 Section 360c(f) Title 21 Section 360c(i) Title 21 Section 360c(i)(1) Title 21 Section 360d Title 21 Section 360d(a) Title 21 Section 360 Title 21 Section 360(g) Title 21 Section 360(i) Title 21 Section 360(j)(1)(A) Title 21 Section 360(j)(1)(D) Title 21 Section 360e(d) Title 21 Section 360e(d)(1)(B) Title 21 Section 360e(f)(2) Title 21 Section 360ee(b)(1)(A) Title 21 Section 360ee(b)(1)(B) Title 21 Section 360g(a) Title 21 Section 360i Title 21 Section 360i(b) Title 21 Section 360i(e) Title 21 Section 360j(f)(1)(B) Title 21 Section 360j(g) Title 21 Section 360j(h)(4) Title 21 Section 360j(l) Title 21 Section 360j(m) Title 21 Section 360l Title 21 Section 371 Title 21 Section 371et seq. Title 21 Section 374 Title 21 Section 374(a)(1) Title 21 Section 379a Title 21 Section 379g Title 21 Section 379g(1)(C) Title 21 Section 379get seq. Title 21 Section 379h Title 21 Section 379h(a) Title 21 Section 379h(b) Title 21 Section 379h(c) Title 21 Section 379h(d) Title 21 Section 379h(f)(1) Title 21 Section 379h(g) Title 21 Section 381(d)(1) Title 21 Section 382 Title 21 Section 383 Title 21 Section 391et seq. Title 21 Section 393 Title 21 Section 802(9)(A) 21 U.S.C. 301et seq. 21 U.S.C. 321 21 U.S.C. 321(aa) 21 U.S.C. 321(dd) 21 U.S.C. 321(ff)(3)(A) 21 U.S.C. 331 21 U.S.C. 331(e) 21 U.S.C. 331(i)(1) 21 U.S.C. 331(j) 21 U.S.C. 334(d)(1) 21 U.S.C. 335a(d)(4)(B)(ii) 21 U.S.C. 341et seq. 21 U.S.C. 343(r) 21 U.S.C. 343(r)(2) 21 U.S.C. 343(r)(2)(B) 21 U.S.C. 343(r)(3) 21 U.S.C. 343(r)(4)(A)(i) 21 U.S.C. 348 21 U.S.C. 348(a) 21 U.S.C. 351(a) 21 U.S.C. 351(a)(2)(C) 21 U.S.C. 351(e) 21 U.S.C. 351et seq. 21 U.S.C. 352 21 U.S.C. 352(a) 21 U.S.C. 352(d) 21 U.S.C. 352(e)(1) 21 U.S.C. 353 21 U.S.C. 353(b)(1) 21 U.S.C. 353(b)(3) 21 U.S.C. 353(b)(4) 21 U.S.C. 353(g)(4) 21 U.S.C. 355 21 U.S.C. 355(b) 21 U.S.C. 355(b)(1) 21 U.S.C. 355(c) 21 U.S.C. 355(d) 21 U.S.C. 355(i) 21 U.S.C. 355(j) 21 U.S.C. 356 21 U.S.C. 357 21 U.S.C. 360aa(a) 21 U.S.C. 360bb 21 U.S.C. 360bb(b) 21 U.S.C. 360b(c) 21 U.S.C. 360cc(a) 21 U.S.C. 360cc(b) 21 U.S.C. 360c(a)(3) 21 U.S.C. 360c(a)(3)(A) 21 U.S.C. 360c(b) 21 U.S.C. 360c(f) 21 U.S.C. 360c(i) 21 U.S.C. 360c(i)(1) 21 U.S.C. 360d 21 U.S.C. 360d(a) 21 U.S.C. 360 21 U.S.C. 360(g) 21 U.S.C. 360(i) 21 U.S.C. 360(j)(1)(A) 21 U.S.C. 360(j)(1)(D) 21 U.S.C. 360e(d) 21 U.S.C. 360e(d)(1)(B) 21 U.S.C. 360e(f)(2) 21 U.S.C. 360ee(b)(1)(A) 21 U.S.C. 360ee(b)(1)(B) 21 U.S.C. 360g(a) 21 U.S.C. 360i 21 U.S.C. 360i(b) 21 U.S.C. 360i(e) 21 U.S.C. 360j(f)(1)(B) 21 U.S.C. 360j(g) 21 U.S.C. 360j(h)(4) 21 U.S.C. 360j(l) 21 U.S.C. 360j(m) 21 U.S.C. 360l 21 U.S.C. 371 21 U.S.C. 371et seq. 21 U.S.C. 374 21 U.S.C. 374(a)(1) 21 U.S.C. 379a 21 U.S.C. 379g 21 U.S.C. 379g(1)(C) 21 U.S.C. 379get seq. 21 U.S.C. 379h 21 U.S.C. 379h(a) 21 U.S.C. 379h(b) 21 U.S.C. 379h(c) 21 U.S.C. 379h(d) 21 U.S.C. 379h(f)(1) 21 U.S.C. 379h(g) 21 U.S.C. 381(d)(1) 21 U.S.C. 382 21 U.S.C. 383 21 U.S.C. 391et seq. 21 U.S.C. 393 21 U.S.C. 802(9)(A) Title 35 Section 156(f)(4)(B) 35 U.S.C. 156(f)(4)(B) Title 38 Section 8126(h)(2) 38 U.S.C. 8126(h)(2) Title 42 Section 201et seq. Title 42 Section 247b-7 Title 42 Section 262 Title 42 Section 262(a) Title 42 Section 262(b) Title 42 Section 262(c) Title 42 Section 262(d) Title 42 Section 263a(d) Title 42 Section 282 Title 42 Section 299et seq. Title 42 Section 379h Title 42 Section 4332(2)(C) 42 U.S.C. 201et seq. 42 U.S.C. 247b-7 42 U.S.C. 262 42 U.S.C. 262(a) 42 U.S.C. 262(b) 42 U.S.C. 262(c) 42 U.S.C. 262(d) 42 U.S.C. 263a(d) 42 U.S.C. 282 42 U.S.C. 299et seq. 42 U.S.C. 379h 42 U.S.C. 4332(2)(C) Volume 105 Page 1677 105 Stat. 1677 Volume 111 Page 2296 Volume 111 Page 2297 Volume 111 Page 2298 Volume 111 Page 2299 Volume 111 Page 2300 Volume 111 Page 2301 Volume 111 Page 2302 Volume 111 Page 2303 Volume 111 Page 2304 Volume 111 Page 2305 Volume 111 Page 2306 Volume 111 Page 2307 Volume 111 Page 2308 Volume 111 Page 2309 Volume 111 Page 2310 Volume 111 Page 2311 Volume 111 Page 2312 Volume 111 Page 2313 Volume 111 Page 2314 Volume 111 Page 2315 Volume 111 Page 2316 Volume 111 Page 2317 Volume 111 Page 2318 Volume 111 Page 2319 Volume 111 Page 2320 Volume 111 Page 2321 Volume 111 Page 2322 Volume 111 Page 2323 Volume 111 Page 2324 Volume 111 Page 2325 Volume 111 Page 2326 Volume 111 Page 2327 Volume 111 Page 2328 Volume 111 Page 2329 Volume 111 Page 2330 Volume 111 Page 2331 Volume 111 Page 2332 Volume 111 Page 2333 Volume 111 Page 2334 Volume 111 Page 2335 Volume 111 Page 2336 Volume 111 Page 2337 Volume 111 Page 2338 Volume 111 Page 2339 Volume 111 Page 2340 Volume 111 Page 2341 Volume 111 Page 2342 Volume 111 Page 2343 Volume 111 Page 2344 Volume 111 Page 2345 Volume 111 Page 2346 Volume 111 Page 2347 Volume 111 Page 2348 Volume 111 Page 2349 Volume 111 Page 2350 Volume 111 Page 2351 Volume 111 Page 2352 Volume 111 Page 2353 Volume 111 Page 2354 Volume 111 Page 2355 Volume 111 Page 2356 Volume 111 Page 2357 Volume 111 Page 2358 Volume 111 Page 2359 Volume 111 Page 2360 Volume 111 Page 2361 Volume 111 Page 2362 Volume 111 Page 2363 Volume 111 Page 2364 Volume 111 Page 2365 Volume 111 Page 2366 Volume 111 Page 2367 Volume 111 Page 2368 Volume 111 Page 2369 Volume 111 Page 2370 Volume 111 Page 2371 Volume 111 Page 2372 Volume 111 Page 2373 Volume 111 Page 2374 Volume 111 Page 2375 Volume 111 Page 2376 Volume 111 Page 2377 Volume 111 Page 2378 Volume 111 Page 2379 Volume 111 Page 2380 111 Stat. 2296 111 Stat. 2297 111 Stat. 2298 111 Stat. 2299 111 Stat. 2300 111 Stat. 2301 111 Stat. 2302 111 Stat. 2303 111 Stat. 2304 111 Stat. 2305 111 Stat. 2306 111 Stat. 2307 111 Stat. 2308 111 Stat. 2309 111 Stat. 2310 111 Stat. 2311 111 Stat. 2312 111 Stat. 2313 111 Stat. 2314 111 Stat. 2315 111 Stat. 2316 111 Stat. 2317 111 Stat. 2318 111 Stat. 2319 111 Stat. 2320 111 Stat. 2321 111 Stat. 2322 111 Stat. 2323 111 Stat. 2324 111 Stat. 2325 111 Stat. 2326 111 Stat. 2327 111 Stat. 2328 111 Stat. 2329 111 Stat. 2330 111 Stat. 2331 111 Stat. 2332 111 Stat. 2333 111 Stat. 2334 111 Stat. 2335 111 Stat. 2336 111 Stat. 2337 111 Stat. 2338 111 Stat. 2339 111 Stat. 2340 111 Stat. 2341 111 Stat. 2342 111 Stat. 2343 111 Stat. 2344 111 Stat. 2345 111 Stat. 2346 111 Stat. 2347 111 Stat. 2348 111 Stat. 2349 111 Stat. 2350 111 Stat. 2351 111 Stat. 2352 111 Stat. 2353 111 Stat. 2354 111 Stat. 2355 111 Stat. 2356 111 Stat. 2357 111 Stat. 2358 111 Stat. 2359 111 Stat. 2360 111 Stat. 2361 111 Stat. 2362 111 Stat. 2363 111 Stat. 2364 111 Stat. 2365 111 Stat. 2366 111 Stat. 2367 111 Stat. 2368 111 Stat. 2369 111 Stat. 2370 111 Stat. 2371 111 Stat. 2372 111 Stat. 2373 111 Stat. 2374 111 Stat. 2375 111 Stat. 2376 111 Stat. 2377 111 Stat. 2378 111 Stat. 2379 111 Stat. 2380 H. Rept. 105-399 S. Rept. 105-43